FDA Registration
Active
🇺🇸 United States
ConforMIS, Inc.
Reg #: 3004153240
·
FEI: 3004153240
·
Expires 2026
Products
12
Proprietary Names
580
Establishment Types
6
Classifications
12
Registration Details
- Registration Name
- ConforMIS, Inc.
- Registration Number
- 3004153240
- FEI Number
- 3004153240
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 600 Research Dr
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072586
Owner / Operator
- Firm Name
- restor3d, Inc.
- Operator Number
- 9058483
- Address
- 4001 NC-54, Suite 3160
- City
- Durham
- State
- NC
- Postal Code
- 27709
- Country
- US
- Correspondent
- Brianna Prindle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2010-12-02 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2021-05-20 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-05-20 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2021-05-20 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2010-12-02 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-12-29 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2025-12-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-12-29 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2025-12-29 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2017-03-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-08-24 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2023-08-01 |
Proprietary Names
IUNI IJIG INSTRUMENTS
IUNI KRS
IUNI IJIG COMPONENTS
IUNI UNICONDYLAR KNEE REPAIR SYSTEM
IUNI UNICONDYLAR KNEE REPLACEMENT
IUNI IJIG ANCILLARY INSTRUMENTS
IUNI UNICONDYLAR KNEE REPAIR
IUNI KNEE REPAIR
IUNI KNEE RESURFACING
IUNI
IUNI KNEE REPLACEMENT
IUNI PARTIAL KNEE REPLACEMENT
IUNI KNEE REPAIR SYSTEM
IUNI UNICONDYLAR KNEE RESURFACING
IUNI UNICONDYLAR KNEE RESURFACING SYSTEM
IUNI KNEE RESURFACING SYSTEM
IUNI IJIGS
IUNI PARTIAL KNEE REPLACEMENT SYSTEM
IUNI KNEE REPLACEMENT SYSTEM
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
Identity Imprint Knee Replacement System
iTotal PS Knee Replacement System
iTotal Posterior Stabilized Knee Replacement System
IUNI G2 UNICONDYLAR KNEE RESURFACING
IUNI G2
IUNI G2 IJIGS
IUNI G2 KNEE RESURFACING
IUNI G2 IJIG INSTRUMENTS
IUNI G2 KNEE REPLACEMENT SYSTEM
IUNI G2 UNICONDYLAR KNEE RESURFACING SYSTEM
IUNI G2 PARTIAL KNEE REPLACEMENT
IUNI G2 KNEE RESURFACING SYSTEM
IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM
IUNI G2 IJIG ANCILLARY INSTRUMENTS
IUNI G2 KNEE REPAIR
IUNI G2 PARTIAL KNEE REPLACEMENT SYSTEM
IUNI G2 KRS
IUNI G2 UNICONDYLAR KNEE REPAIR
IUNI G2 UNICONDYLAR KNEE REPLACEMENT
IUNI G2 IJIG COMPONENTS
IUNI G2 KNEE REPLACEMENT
IUNI G2 KNEE REPAIR SYSTEM
IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM
iTotal CR Knee Replacement System
ITOTAL CR KNEE REPLACEMENT SYSTEM
ITOTAL CR CRUCIATE RETAINING INSTRUMENT SET
ITOTAL CR CRUCIATE RETAINING IJIGS
ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM
ITOTAL CRUCIATE RETAINING INSTRUMENT SET
ITOTAL CR
ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM
ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY
ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE
ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT
ITOTAL CR KRS
ITOTAL CRUCIATE RETAINING KRS
ITOTAL CRUCIATE RETAINING IJIGS
ITOTAL CR KNEE REPLACEMENT
ITOTAL G2
ITOTAL G2 KNEE REPLACEMENT
ITOTAL G2 IJIG ANCILLARY INSTRUMENTS
ITOTAL CR TOTAL KNEE REPLACEMENT SYSTEM
ITOTAL CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS
ITOTAL KNEE REPLACEMENT SYSTEM
ITOTAL CR INSERT
ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT
ITOTAL CR CRUCIATE RETAINING IJIG INSTRUMENTS
ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT
ITOTAL IJIG ANCILLARY INSTRUMENTS
ITOTAL G2 IJIG COMPONENTS
ITOTAL KRS
ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM
ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM
iTotal: Tibial Component Extended Thickness Range
ITOTAL CR CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS
ITOTAL G2 IJIGS
ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM
ITOTAL CRUCIATE RETAINING TIBIAL TRAY
ITOTAL CR IJIG ANCILLARY INSTRUMENTS
ITOTAL G2 KRS
ITOTAL G2 CRUCIATE RETAINING KNEE REPLACEMENT
ITOTAL G2 CRUCIATE RETAINING IJIG COMPONENTS
ITOTAL G2 IJIG INSTRUMENTS
ITOTAL G2 CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS
ITOTAL KNEE REPLACEMENT
ITOTAL CR CRUCIATE RETAINING
CONFORMIS TOTAL KNEE REPAIR SYSTEM
ITOTAL CRUCIATE RETAINING IJIG COMPONENTS
ITOTAL G2 CRUCIATE RETAINING IJIG INSTRUMENTS
ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY
ITOTAL G2 CRUCIATE RETAINING KRS
ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT
ITOTAL CRUCIATE RETAINING IJIG INSTRUMENTS
ITOTAL G2 TOTAL KNEE REPLACEMENT
ITOTAL CR INSTRUMENT SET
ITOTAL G2 CRUCIATE RETAINING IJIGS
ITOTAL CRUCIATE RETAINING
ITOTAL
ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE
ITOTAL TOTAL KNEE REPLACEMENT
ITOTAL IJIG INSTRUMENTS
ITOTAL CR TOTAL KNEE REPLACEMENT
ITOTAL G2 CRUCIATE RETAINING
ITOTAL CR CRUCIATE RETAINING IJIG COMPONENTS
ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM
ITOTAL CR IJIG COMPONENTS
ITOTAL IJIGS
ITOTAL G2 KNEE REPLACEMENT SYSTEM
ITOTAL IJIG COMPONENTS
ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT
ITOTAL G2 CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM
ITOTAL TOTAL KNEE REPLACEMENT SYSTEM
ITOTAL CR CRUCIATE RETAINING KRS
ITOTAL CR IJIG INSTRUMENTS
ITOTAL CR IJIGS
IDUO G2 BICOMPARTMENTAL RESURFACING
IDUO IJIG COMPONENTS
IDUO G2 BICOMPARTMENTAL KNEE REPAIR
IDUO G2 KNEE REPLACEMENT SYSTEM
IDUO G2 KNEE RESURFACING
IDUO PARTIAL KNEE REPLACEMENT SYSTEM
IDUO BICOMPARTMENTAL KNEE REPLACEMENT
IDUO BICOMPARTMENTAL RESURFACING
IDUO G2
IDUO G2 IJIGS
IDUO KNEE REPAIR SYSTEM
IDUO BICOMPARTMENTAL KNEE REPAIR
IDUO G2 BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
IDUO PARTIAL KNEE REPLACEMENT
IDUO G2 PARTIAL KNEE REPLACEMENT
IDUO G2 BICOMPARTMENTAL RESURFACING SYSTEM
IDUO G2 IJIG ANCILLARY INSTRUMENTS
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
IDUO KRS
IDUO BICOMPARTMENTAL RESURFACING SYSTEM
IDUO G2 PARTIAL KNEE REPLACEMENT SYSTEM
IDUO G2 KRS
IDUO G2 BICOMPARTMENTAL KNEE REPAIR SYSTEM
IDUO KNEE REPAIR
IDUO G2 KNEE REPAIR
IDUO G2 BICOMPARTMENTAL KNEE REPLACEMENT
IDUO G2 KNEE REPLACEMENT
IDUO IJIGS
IDUO G2 IJIG INSTRUMENTS
IDUO BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
IDUO IJIG ANCILLARY INSTRUMENTS
IDUO KNEE RESURFACING
IDUO KNEE RESURFACING SYSTEM
IDUO IJIG INSTRUMENTS
IDUO KNEE REPLACEMENT SYSTEM
IDUO
IDUO KNEE REPLACEMENT
IDUO G2 KNEE RESURFACING SYSTEM
IDUO G2 IJIG COMPONENTS
IDUO G2 KNEE REPAIR SYSTEM
TRAY BASE, PATELLA INSTRUMENTS
iTotal Posterior Stabilitized (PS) Knee Replacement System
iTotal Posterior Stabilitized Knee Replacement System
Velora Acetabular Cup
Radel Liner Impactors 28mm
Cordera Hip System
Cordera Trial Neck 127Degree 36.5mm
Radel Liner Impactors 36mm
Cordera Trial Neck 132deg 36.5mm
Cordera Trial Neck 132degree 29mm
Cordera Trial Neck 127degree 29mm
Radel Liner Impactors 40mm
Radel Liner Impactors 32mm
Paragon Medical Surgical Instrument Delivery System
iTotal Hip Replacement System
ITOTAL IDENTITY CR KRS with CS INSERT
iTotal Identity Posterior Stabilized Knee Replacement System
iUni Unicondylar Knee Replacement System
iDuo Bicompartmental Knee Repair System
Identity Imprint CS Insert
Identity Imprint CR insert trial 18mm
Identity Imprint CS Insert trial
ACTERA (femoral stems sizes 0,1,10,11,12 and patient specific neck sizes 0-12)
Femoral Trial Heads, reusable
ACTERA Trial Necks
ACTERA Broaches 0,1,10,11,12
ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
ITOTAL KEEL PUNCH
ITOTAL CR INSERT IMPACTOR TIP
ITOTAL CR PATELLA REUSUABLE INSTRUMENT SET
ITOTAL CR CRUCIATE RETAINING IMPACTOR HANDLE
ITOTAL CR CRUCIATE RETAINING DRILL BIT WITH STOP
ITOTAL CR CRUCIATE RETAINING KEEL PUNCH TIPS
ITOTAL G2 CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE
ITOTAL G2 DRILL BIT
ITOTAL CR CRUCIATE RETAINING PATELLA SET
ITOTAL CRUCIATE RETAINING FEMORAL DRILL BIT
ITOTAL G2 STEINMAN PIN
ITOTAL UNIVERSAL IMPACTOR HANDLE
ITOTAL FEMORAL DRILL BIT
ITOTAL G2 CRUCIATE RETAINING TRAY IMPACTOR TIP
ITOTAL TACK PIN
ITOTAL CALIPER
IDUO PATELLA TRIAL
ITOTAL CR CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY
ITOTAL CRUCIATE RETAINING TIBIAL DRILL BIT
IDUO G2 PATELLAR OSTEOTOMY GUIDE
IDUO G2 INSTRUMENT TRAY
ITOTAL CRUCIATE RETAINING PATELLA INSTRUMENT TRAY
ITOTAL G2 TOWNLEY CALIPER
ITOTAL POLY IMPACTOR TIP
ITOTAL PATELLA INSTRUMENT TRAY
ITOTAL CRUCIATE RETAINING POLY INSERT IMPACTOR TIP
ITOTAL G2 UNIVERSAL IMPACTOR HEAD
ITOTAL G2 CRUCIATE RETAINING CORING TOOL
ITOTAL G2 TRAY IMPACTOR TIP
ITOTAL CRUCIATE RETAINING PATELLA SIZER
ITOTAL CR PIN PULLER
ITOTAL CR CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD
ITOTAL G2 CRUCIATE RETAINING INSTRUMENT SET
ITOTAL G2 CRUCIATE RETAINING POLY IMPACTOR TIP
ITOTAL CR CRUCIATE RETAINING STEINMAN PIN
ITOTAL CR STERILIZATION TRAY
IDUO G2 PATELLA SET
ITOTAL G2 CRUCIATE RETAINING CALIPER
ITOTAL CR CRUCIATE RETAINING INSTRUMENT TRAY
IDUO G2 TOWNLEY CALIPER
ITOTAL G2 CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE
ITOTAL G2 PIN PULLER
ITOTAL CR TIBIAL DRILL BIT
ITOTAL CRUCIATE RETAINING DRILL BIT
IDUO G2 PATELLA INSTRUMENT SET
ITOTAL CR PATELLAR OSTEOTOMY GUIDE
ITOTAL CR CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP
ITOTAL CRUCIATE RETAINING STEINMAN PIN
IDUO INSTRUMENT SET
ITOTAL G2 CRUCIATE RETAINING TIBIAL DRILL BIT
IDUO DRILL BIT WITH STOP
ITOTAL CRUCIATE RETAINING DRILL SLEEVE
IDUO G2 PATELLA DRILL BIT WITH STOP
ITOTAL CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD
ITOTAL G2 CRUCIATE RETAINING TIBIAL STEM DRILL BIT
IDUO PATELLA SIZER
ITOTAL CR STEINMAN PIN
ITOTAL G2 CRUCIATE RETAINING PATELLA TRIAL
ITOTAL G2 CRUCIATE RETAINING PATELLA INSTRUMENT SET
IDUO PATELLA DRILL BIT
ITOTAL DRILL SLEEVE
ITOTAL G2 CRUCIATE RETAINING STEM DRILL BIT
ITOTAL CR CRUCIATE RETAINING PATELLA INSTRUMENT TRAY
ITOTAL CR TIBIAL DRILL GUIDE SLEEVE
ITOTAL CR TRAY IMPACTOR TIP
ITOTAL G2 KEEL PUNCH TIPS
ITOTAL G2 PATELLA CLAMP
ITOTAL G2 CRUCIATE RETAINING PATELLA DRILL BIT
ITOTAL G2 TIBIAL INSERT IMPACTOR TIP
ITOTAL G2 CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP
ITOTAL CRUCIATE RETAINING POLY IMPACTOR TIP
IDUO PATELLA INSTRUMENT TRAY
ITOTAL CR CRUCIATE RETAINING STERILIZATION TRAY
ITOTAL CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY
ITOTAL CRUCIATE RETAINING TIBIAL STEM DRILL BIT
ITOTAL CR CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET
ITOTAL CRUCIATE RETAINING KEEL PUNCH TIPS
ITOTAL CRUCIATE RETAINING PATELLA DRILL BIT
ITOTAL STEINMAN PIN
ITOTAL CRUCIATE RETAINING CORING TOOL
ITOTAL G2 CRUCIATE RETAINING TOWNLEY CALIPER
ITOTAL CR CRUCIATE RETAINING GUIDANCE PLUG
ITOTAL G2 REUSABLE INSTRUMENT TRAY
ITOTAL G2 CALIPER
ITOTAL CR IMPACTOR HANDLE
ITOTAL G2 REUSABLE INSTRUMENT SET
ITOTAL G2 CRUCIATE RETAINING PATELLA SIZER
ITOTAL G2 CRUCIATE RETAINING PIN PULLER
ITOTAL PATELLA REUSUABLE INSTRUMENT SET
ITOTAL G2 IMPACTOR HANDLE
IDUO PATELLA CLAMP
ITOTAL PATELLA SIZER
ITOTAL PATELLA CLAMP
ITOTAL G2 KEEL PUNCH
ITOTAL CRUCIATE RETAINING PATELLA SET
IDUO STERILIZATION TRAY
IDUO G2 PATELLA CLAMP
ITOTAL REUSABLE INSTRUMENT TRAY
IDUO REUSABLE INSTRUMENT TRAY
ITOTAL CR CRUCIATE RETAINING DRILL SLEEVE
ITOTAL CR CRUCIATE RETAINING DRILL GUIDE SLEEVE
ITOTAL CR CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE
IDUO REUSABLE INSTRUMENT SET
ITOTAL CR CRUCIATE RETAINING PATELLA INSTRUMENT SET
ITOTAL CR CRUCIATE RETAINING POLY INSERT IMPACTOR TIP
ITOTAL CR CRUCIATE RETAINING POLY IMPACTOR TIP
ITOTAL G2 INSTRUMENT TRAY
ITOTAL CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP
ITOTAL G2 GUIDANCE PLUG
ITOTAL G2 CRUCIATE RETAINING STEINMAN PIN
ITOTAL TIBIAL INSERT IMPACTOR TIP
ITOTAL STERILIZATION TRAY
ITOTAL CR KEEL PUNCH TIPS
IDUO G2 DRILL BIT WITH STOP
ITOTAL G2 TIBIAL DRILL BIT
ITOTAL ALIGNMENT ROD
ITOTAL PATELLAR OSTEOTOMY GUIDE
IDUO PATELLA REUSUABLE INSTRUMENT TRAY
ITOTAL G2 PATELLA REUSUABLE INSTRUMENT SET
ITOTAL G2 CRUCIATE RETAINING PATELLA CLAMP
ITOTAL INSTRUMENT SET
IDUO G2 DRILL BIT
IDUO TOWNLEY CALIPER
IDUO G2 PATELLA REUSUABLE INSTRUMENT TRAY
ITOTAL G2 CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE
ITOTAL G2 CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY
IDUO PATELLA INSTRUMENT SET
ITOTAL CRUCIATE RETAINING PATELLA TRIAL
ITOTAL G2 PATELLAR OSTEOTOMY GUIDE
ITOTAL IMPACTOR HANDLE
IDUO G2 PATELLA TRAY
ITOTAL CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP
ITOTAL G2 CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD
ITOTAL CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY
ITOTAL CR CRUCIATE RETAINING PATELLA CLAMP
IDUO G2 PATELLA REUSUABLE INSTRUMENT SET
ITOTAL G2 TACK PIN
ITOTAL CRUCIATE RETAINING TACK PIN
ITOTAL UNIVERSAL IMPACTOR HEAD
ITOTAL PATELLA INSTRUMENT SET
IDUO PATELLA SET
IDUO G2 REUSABLE INSTRUMENT SET
IDUO G2 PATELLA DRILL BIT
ITOTAL CR CRUCIATE RETAINING KEEL PUNCH
ITOTAL PIN PULLER
IDUO OSTEOTOMY GUIDE
ITOTAL G2 POLY INSERT IMPACTOR TIP
ITOTAL PATELLA DRILL BIT
ITOTAL POLY INSERT IMPACTOR TIP
ITOTAL CR CRUCIATE RETAINING OSTEOTOMY GUIDE
ITOTAL G2 CRUCIATE RETAINING STERILIZATION TRAY
ITOTAL CR PATELLA TRAY
ITOTAL TRAY IMPACTOR TIP
ITOTAL G2 OSTEOTOMY GUIDE
ITOTAL G2 STERILIZATION TRAY
ITOTAL CRUCIATE RETAINING INSERT IMPACTOR TIP
ITOTAL INSTRUMENT TRAY
ITOTAL G2 INSTRUMENT SET
ITOTAL CR GUIDANCE PLUG
IDUO G2 CALIPER
ITOTAL REUSABLE INSTRUMENT SET
ITOTAL CR OSTEOTOMY GUIDE
ITOTAL CRUCIATE RETAINING CALIPER
ITOTAL TIBIAL DRILL GUIDE SLEEVE
ITOTAL CR DRILL BIT
IDUO G2 REUSABLE INSTRUMENT TRAY
ITOTAL G2 CRUCIATE RETAINING FEMORAL DRILL BIT
ITOTAL CR TOWNLEY CALIPER
ITOTAL G2 PATELLA DRILL BIT
ITOTAL CR PATELLA CLAMP
ITOTAL G2 PATELLA SET
ITOTAL CR POLY IMPACTOR TIP
ITOTAL CR REUSABLE INSTRUMENT TRAY
ITOTAL CR PATELLA INSTRUMENT TRAY
ITOTAL G2 CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET
ITOTAL CRUCIATE RETAINING GUIDANCE PLUG
ITOTAL CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP
ITOTAL KEEL PUNCH TIPS
IDUO CALIPER
ITOTAL CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE
ITOTAL G2 CRUCIATE RETAINING PATELLA TRAY
ITOTAL G2 UNIVERSAL IMPACTOR HANDLE
ITOTAL CR CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE
ITOTAL G2 CRUCIATE RETAINING INSTRUMENT TRAY
ITOTAL CR CRUCIATE RETAINING TRAY IMPACTOR TIP
ITOTAL CR CRUCIATE RETAINING ALIGNMENT ROD
ITOTAL OSTEOTOMY GUIDE
IDUO PATELLAR OSTEOTOMY GUIDE
ITOTAL G2 CRUCIATE RETAINING TACK PIN
ITOTAL CR CRUCIATE RETAINING PATELLA DRILL BIT
ITOTAL DRILL GUIDE SLEEVE
ITOTAL G2 PATELLA TRIAL
ITOTAL PATELLA TRIAL
ITOTAL CR INSTRUMENT TRAY
ITOTAL CR TACK PIN
ITOTAL GUIDANCE PLUG
ITOTAL G2 TIBIAL DRILL GUIDE SLEEVE
ITOTAL CR CRUCIATE RETAINING STEM DRILL BIT
ITOTAL G2 CRUCIATE RETAINING OSTEOTOMY GUIDE
ITOTAL G2 INSERT IMPACTOR TIP
ITOTAL CR PATELLA DRILL BIT
ITOTAL G2 CRUCIATE RETAINING IMPACTOR HANDLE
ITOTAL G2 CRUCIATE RETAINING GUIDANCE PLUG
ITOTAL CR CRUCIATE RETAINING REUSABLE INSTRUMENT SET
ITOTAL G2 FEMORAL DRILL BIT
ITOTAL TIBIAL STEM DRILL BIT
IDUO G2 INSTRUMENT SET
ITOTAL G2 CRUCIATE RETAINING DRILL BIT WITH STOP
ITOTAL CRUCIATE RETAINING STEM DRILL BIT
ITOTAL CR CRUCIATE RETAINING PATELLA TRAY
ITOTAL G2 PATELLA INSTRUMENT TRAY
ITOTAL G2 CRUCIATE RETAINING DRILL SLEEVE
ITOTAL CR CRUCIATE RETAINING CORING TOOL
ITOTAL CR TIBIAL INSERT IMPACTOR TIP
ITOTAL TOWNLEY CALIPER
IDUO PATELLA TRAY
ITOTAL G2 CRUCIATE RETAINING INSERT IMPACTOR TIP
ITOTAL CR CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY
ITOTAL CR UNIVERSAL IMPACTOR HEAD
ITOTAL CR CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP
ITOTAL CR CRUCIATE RETAINING TIBIAL STEM DRILL BIT
ITOTAL CR DRILL SLEEVE
ITOTAL G2 CRUCIATE RETAINING KEEL PUNCH TIPS
ITOTAL CR CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP
ITOTAL CR CRUCIATE RETAINING DRILL BIT
ITOTAL PATELLA REUSUABLE INSTRUMENT TRAY
ITOTAL CRUCIATE RETAINING IMPACTOR HANDLE
ITOTAL CR REUSABLE INSTRUMENT SET
ITOTAL CR CRUCIATE RETAINING TACK PIN
ITOTAL G2 PATELLA SIZER
ITOTAL CR DRILL BIT WITH STOP
ITOTAL CR CRUCIATE RETAINING PATELLA TRIAL
ITOTAL STEM DRILL BIT
ITOTAL G2 PATELLA INSTRUMENT SET
IDUO G2 PATELLA INSTRUMENT TRAY
IDUO INSTRUMENT TRAY
ITOTAL CR KEEL PUNCH
ITOTAL CRUCIATE RETAINING PIN PULLER
ITOTAL TIBIAL DRILL BIT
ITOTAL G2 CRUCIATE RETAINING POLY INSERT IMPACTOR TIP
ITOTAL G2 CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP
ITOTAL CR PATELLA REUSUABLE INSTRUMENT TRAY
ITOTAL CR CRUCIATE RETAINING FEMORAL DRILL BIT
ITOTAL CRUCIATE RETAINING PATELLA CLAMP
ITOTAL G2 PATELLA REUSUABLE INSTRUMENT TRAY
ITOTAL CR TIBIAL TRAY IMPACTOR TIP
ITOTAL CRUCIATE RETAINING KEEL PUNCH
ITOTAL G2 TIBIAL TRAY IMPACTOR TIP
ITOTAL G2 DRILL BIT WITH STOP
IDUO PATELLA DRILL BIT WITH STOP
ITOTAL G2 DRILL SLEEVE
ITOTAL DRILL BIT WITH STOP
ITOTAL CR CRUCIATE RETAINING TIBIAL DRILL BIT
IDUO G2 OSTEOTOMY GUIDE
ITOTAL CR CRUCIATE RETAINING PATELLA SIZER
ITOTAL G2 CRUCIATE RETAINING KEEL PUNCH
ITOTAL G2 CRUCIATE RETAINING DRILL BIT
ITOTAL CR DRILL GUIDE SLEEVE
ITOTAL PATELLA TRAY
ITOTAL G2 ALIGNMENT ROD
ITOTAL G2 CRUCIATE RETAINING DRILL GUIDE SLEEVE
ITOTAL CR ALIGNMENT ROD
ITOTAL CR PATELLA DRILL BIT WITH STOP
ITOTAL CR PATELLA SIZER
IDUO G2 PATELLA SIZER
ITOTAL CR CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE
ITOTAL CRUCIATE RETAINING OSTEOTOMY GUIDE
ITOTAL PATELLA SET
ITOTAL G2 CRUCIATE RETAINING PATELLA SET
ITOTAL CR PATELLA INSTRUMENT SET
ITOTAL CRUCIATE RETAINING STERILIZATION TRAY
ITOTAL CRUCIATE RETAINING INSTRUMENT TRAY
IDUO PATELLA REUSUABLE INSTRUMENT SET
ITOTAL CR CORING TOOL
ITOTAL PATELLA DRILL BIT WITH STOP
ITOTAL CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET
ITOTAL CR UNIVERSAL IMPACTOR HANDLE
ITOTAL CR CRUCIATE RETAINING TOWNLEY CALIPER
ITOTAL G2 CORING TOOL
ITOTAL INSERT IMPACTOR TIP
ITOTAL G2 CRUCIATE RETAINING REUSABLE INSTRUMENT SET
ITOTAL CRUCIATE RETAINING TOWNLEY CALIPER
ITOTAL CR TIBIAL STEM DRILL BIT
ITOTAL G2 TIBIAL STEM DRILL BIT
ITOTAL CR CRUCIATE RETAINING INSERT IMPACTOR TIP
ITOTAL CRUCIATE RETAINING ALIGNMENT ROD
IDUO G2 PATELLA TRIAL
ITOTAL CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE
ITOTAL CR PATELLA SET
ITOTAL CR CALIPER
ITOTAL CR CRUCIATE RETAINING CALIPER
ITOTAL DRILL BIT
ITOTAL G2 CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY
ITOTAL G2 CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP
ITOTAL G2 POLY IMPACTOR TIP
ITOTAL CRUCIATE RETAINING PATELLA TRAY
ITOTAL G2 PATELLA DRILL BIT WITH STOP
ITOTAL G2 DRILL GUIDE SLEEVE
ITOTAL TIBIAL TRAY IMPACTOR TIP
ITOTAL CR STEM DRILL BIT
ITOTAL CRUCIATE RETAINING DRILL GUIDE SLEEVE
ITOTAL CR POLY INSERT IMPACTOR TIP
ITOTAL CRUCIATE RETAINING DRILL BIT WITH STOP
ITOTAL CR PATELLA TRIAL
ITOTAL CR FEMORAL DRILL BIT
ITOTAL CRUCIATE RETAINING PATELLA INSTRUMENT SET
ITOTAL CR CRUCIATE RETAINING PIN PULLER
ITOTAL G2 CRUCIATE RETAINING ALIGNMENT ROD
ITOTAL G2 PATELLA TRAY
ITOTAL CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE
ITOTAL G2 STEM DRILL BIT
ITOTAL CRUCIATE RETAINING REUSABLE INSTRUMENT SET
ITOTAL CORING TOOL
ITOTAL G2 CRUCIATE RETAINING PATELLA INSTRUMENT TRAY
IDUO DRILL BIT
ITOTAL CRUCIATE RETAINING TRAY IMPACTOR TIP
IDUO G2 STERILIZATION TRAY
Trifecta Universal Reusable Instrument Lid 1080-125
OrthoGroup Cup Impactor
Femoral Stem Extractor Handle Extension
iTotal/ Identity/ Imprint Femoral Plug
Trifecta Identity Reusable Instrument Tray with Insert 1080-127
Cordera Acetabular Reusable Instrument Tray insert and base
Blunt Steinman Pins
Offset Cup Impactor Enztec
T-handle Quick Connect
Femoral Stem Extractor Straight Adaptor Threaded
Femoral Stem Extractor Loop Adaptor
iTotal iPoly Impactor Tip
iTotal Poly Impactor
Femoral Stem Extractor Handle
Cordera Femoral Reusable Instrument Tray insert and base
iTotal Patella Implant sizers
Offset Reamer Driver Enztec
Identity/ Imprint Patellar Osteotomy Guide
Identity Imprint Porous Patella Clamp
Hip Broach Handle Neutral
DRILL, DIA 5.5MM X 79MM, W/STOP
Flex drills: 3.5mm x 35mm; 3.5mm x 50mm; 5.5mm x 25mm
Femoral Head Remover
Calcar Planer Adaptor Short
Calcar Planer
Calcar Planer Adaptor
Acetabular reamer handle and sleeve
Drill Guide, double ended
iTotal Impactor Head
iTotal CORING TOOL W/ HUDSON ADAPTOR
iDuo Patella Trials
Tapered Femoral Reamer
PATELLA, DRILL BIT, 5.5MM W/ HUDSON ADAPTOR
Actera Trial Necks single Use
iTotal STEM DRILL 10MM W/ HUDSON ADAPTOR
Modular Box Osteotome 8MM X 20MM
Femoral canal finder
Acetabular Cup Impactor
iDuo Patella Implant Sizers
Screw driver- rigid and flexible
Broach Handles Gen 2 Neutral, offset right, offset left
Threaded Cup Impactor Long
Identity Imprint Porous half keel punches: small, medium, large
Drill Guide
Identity Imprint Porous Steering Femoral Inserter
3.5MM Hex U-Joint Driver
iTotal Patella trials
Bone Rasp
Hip Broach Handle Offset left
Femoral Stem Impactor, offset
Femoral Rasp
iTotal Keel Punch Tips, PS or CR, Serrated or Non-serrated
iTotal PS Tibial Tray Impactor tip
Pin Puller
Hip Broach Handle Offset right
Threaded Headed Pin
screw driver handle
Identity Imprint Porous Patella Drill bits
iTotal STEM DRILL 12MM W/ HUDSON ADAPTOR
Screw Holding forceps
Femoral Head Impactor
ANGEL WING RESECTION GUIDE
Ratcheting Quick-Connect Handle
ITOTAL FEMORAL DRILL BIT 8MM W/ HUDSON ADAPTOR
ITOTAL STEM DRILL 14MM W/ HUDSON ADAPTOR
Universal Trail Heads: 28MM, 32MM, 38MM, 40MM
iTotal Alignment Rod Taper 150mm
Depth gauge
PATELLA CLAMP ASSEMBLY
ITOTAL STEINMAN PIN 3.18MM
iTotal Identity Impactor Handle
Femoral Stem Impactor
Identity Imprint Porous CR Femoral implants
Identity Imprint Porous CR Round Patella Implants
Identity Imprint Porous CR Ancillary Reusable instrument tray with lid
Identity Imprint Porous CR iJigs
Identity Imprint Porous CR Oval Patella Implants
Identity Imprint Porous CR Tibial Implants
Identity Imprint Porous CR KRS
Triathlon AS-1
iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System
Establishment Types
Manufacture Medical Device
Reprocess Single-Use Device
Remanufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198