FDA Registration
Active
🇺🇸 United States
TOTAL JOINT ORTHOPEDICS, INC.
Reg #: 3008544874
·
FEI: 3008544874
·
Expires 2026
Products
21
Proprietary Names
340
Establishment Types
2
Classifications
21
Registration Details
- Registration Name
- TOTAL JOINT ORTHOPEDICS, INC.
- Registration Number
- 3008544874
- FEI Number
- 3008544874
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1567 E. Stratford Avenue
- City
- Salt Lake City
- State
- UT
- ZIP
- 84106
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161073
Owner / Operator
- Firm Name
- Total Joint Orthopedics, Inc
- Operator Number
- 10036774
- Address
- 1567 E. Stratford Avenue
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84106
- Country
- US
- Correspondent
- Brendan Perkins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2025-04-02 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2024-09-04 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2023-05-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2016-10-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2016-10-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2016-10-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2016-10-20 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2022-01-18 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2022-01-18 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-03-16 |
| Template | HWT | Class 1 | Orthopedic | No | 2025-04-02 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2019-09-11 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2015-07-30 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-04-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-05-24 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2024-09-04 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2014-02-20 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-05-23 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2025-04-02 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-04-02 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2025-04-02 |
Proprietary Names
Femoral Head Remover, Corkscrew
Cone Extractor
BiPolar Head Extractor
Femoral Stem Extractor Hoop
Modular Slap Hammer Extractor Impactor
Offset Femoral Stem Trial Extractor
Femoral Stem Adapter Wrench
Spline Wrench Handle Cover
Spline Wrench Handle
Spline Wrench, Closed
Spline Wrench
Klassic HD Acetabular Inserts with XLPE
Klassic Femur with Aurum
Klassic® All-Poly Tibias, Ultra-PS®, Std Poly
Klassic® All-Poly Tibia, CR/Congruent, Std Poly
BIOLOX OPTION Femoral Heads
Adapters for BIOLOX OPTION Femoral Heads
BIOLOX delta Femoral Heads
Klassic Tibial Insert, Ultra-PS, E-Link Poly
Klassic Domed Patella with E-Link
Klassic Sombrero Patella with E-LInk
Klassic Tibial Insert, CR/Congruent, E-Link Poly
Klassic Knee Tibial Insert, PS-Post, Std Poly
Klassic Knee Femur, PS-Post
Klassic Knee Femoral Peg
Klassic Knee Tibial Insert, PS-Post, E-Link Poly
Klassic Blade Femoral Stems, Sizes 10-12
Klassic Blade Offest Femoral Stems, Sizes 10-12
Klassic Knee Templates, Stem Extensions
Acetabular X-Ray Templates
Klassic Knee Templates, PS-Max
BiPolar X-Ray Template Set
Platform Cup X-ray Template
Femoral X-Ray Templates
Klassic Knee Template, Tibial Baseplate, Revision
Cone X-Ray Template
Offset Femoral Stem X-Ray Templates
BIOLOX CONTOURA Ceramic Femoral Head
Klassic Tibial Insert, CR/Congruent, Std Poly, sizes 1-6, 18mm
Klassic Tibial Insert, Ultra-PS, Std Poly, Sizes 1-6, 18mm
Klassic HD Low Profile Acetabular Insert with E-Link Poly
Klassic HD Hooded Acetabular Insert with E-Link Poly
Klassic BiPolar 22mm Femoral Head
Klassic BiPolar Head
Klassic BiPolar 28mm Femoral Head
Klassic HD Acetabular Insert with E-Link Poly, 28mm head
Klassic HD Hooded Acetabular Insert with E-Link Poly, 28mm head
Klassic HD Acetabular Cup with Ti-Coat, 44mm
Klassic HD Low Profile Acetabular Insert with E-Link Poly, 22mm head
Klassic HD Hooded Acetabular Insert with XLPE
28mm BIOLOX delta Ceramic Femoral Head
Klassic HD Low Profile Acetabular Insert with XLPE
Klassic HD Acetabular Insert with E-Link Poly, 22mm head
Klassic HD Acetabular Insert with XLPE, 22mm head
Klassic HD Low Profile Acetabular Insert with E-Link Poly, 28mm head
Klassic HD Acetabular Insert with XLPE, 28mm head
22mm BIOLOX delta Ceramic Femoral Head
Klassic HD Acetabular Cup with Ti-Coat, 46mm
Klassic HD Hooded Acetabular Insert with E-Link Poly, 22mm head
28mm BIOLOX OPTION Femoral Head, 16/18 taper
Acetabular U-Joint Screwdriver
3.5mm Hex Screwdriver, Klassic ONE
3.5mm Hex Screwdriver Metal Handle
3.5mm Hex Screwdriver
Klassic Tibial Insert, PS-Post, Std Poly
Klassic All-Poly Tibia, PS-Post, Std Poly
Klassic All Poly Tibia, PS-Post, E-Link Poly
Klassic Tibial Insert, PS-Post, E-Link Poly
Klassic Sombrero Patella with E-Link, Size 5, 10mm thickness
Klassic Sombrero Patella, Size 5, 10mm thickness
Klassic Tibial Insert, PS-Max, Standard Poly
Klassic HD Acetabular Insert with E-Link Poly
Distal Femoral Cut Block Connector
Tibial Reamer, Square Tip
Magnet Spacer, 5mm
Klassic BiPolar Femoral Head Trials
Femoral Neck Osteotomy Ruler
Sombrero Patella Trials
Universal Cut Block
Bent Retrators
Alignment Tower
Klassic BiPolar Sizing Ring Assembly
Klassic HD Acetabular Cup Sizers
Klassic BiPolar Trial
Flexion/Extension Cut Block
A/P Sizer
Domed Patella Trials
Tibial Stem Extension Reamer Shaft and Stop
Tibial Stem Extension Trials
Klassic Femoral Head Trials
Patella Sizer/Drill Guide/Tibial Stem Wrench
Intramedullary Rod (IM/Rod)
Klassic HD Acetabular Cup Positioner, Threaded Shaft
Quick Pins
Knee Slaphammer
Box Chisel
Femoral Neck Osteotomy Guide
Tibial Stem Extension Reamer Guide
Alignment Rod
Klassic BiPolar Sizing Plate
Tibial Baseplate Trials-Flat
Tibial Stylus
Pin Puller
Klassic HD Acetabular Insert Trials
Universal Handle
Calcar Planer
Patella Clamp
Femoral Cut Blocks
T-Handle
Modular Broach Holder, Single Offset
Femoral Stem Thread Adapter
Slap Hammer, Hip
Klassic HD Neck Trials
Tibial Alignment Guides
Femoral Adapter Sleeve Puller
Patella Calipers
Klassic HD Acetabular Cup Positioner, Handle
Tibial Baseplate Trials, Keeled
Patella Osteotomy Guide
Modular Broach Holder, Straight
Femur/Tibia Implant Impactor-Handle
Varus/Valgus Cut Block
Klassic BiPolar Sizing Handles
Klassic® Blade Box Chisel
Spiked Upper Tibial Tower
Femoral Trials
Klassic HD Offset Femoral Stem Trials
Femoral Head Remover
Klassic HD Cup Positioner, Tower
Distal Femoral Cut Guide
Patella Planers
Tibial Insert Trials
Angel Wing
Tibial Insert Assembly Clamp
Hip Retractors
Klassic HD Non Modular Broach Holder, Straight
All-Poly Tibial Broach Tower Assemblies
Klassic Blade Femoral Canal Finder Rasp
Anteversion Rod, Hip
Klassic Blade Neck Trials
Tibial Baseplate Sizers
Femoral Head Trials
Sterile Drill and Pin Sets
Klassic® Blade Box Chisel, Curved
Klassic® Blade Femoral Canal Finder Rasp, Curved
Hooded Acetabular Insert Trial
Tibial Stylus, Threaded
Klassic BiPolar Sizing Handles, Locking
MIS Cutblock - Right
Stem Impaction Adapter
Klassic BiPolar Trials, Locking
MIS Cutblock - Left
Modular Impactor Handle
Simple Gap Block, Straight
Modular Reamer Driver
Femoral Cut Block, Pegless
Tibial Insert Trial, PS-Post
PS-Post Box Trial
Pin Driver, 2.5mm Hex
Fluted Pin, Square Head
Acetabular Angled Drill Driver
Acetabular Angled Drill Guide
A/P Sizer, Pegless
Acetabular Depth Gage
Tibial Baseplate Trial, Pegless
Screw Pin, Hex Head
Distal Femoral Cut Guide, Modular
Femur Trial, PS-Post/Revision
Tibial Alignment Guide 0 degree Upper Tower
PS-Post Box Resection Guide
Klassic HD Femoral Canal Finder, Modular
Tibial Sizer, Captured Pin, Klassic ONE
Patella Sizer/ Clamp/ Drill Guide/ Reamer, Klassic ONE, Handle
Femoral Cut Block, Narrow
Alignment Rod, Klassic ONE
Tibial Alignment Guide 6 degrees Spike Upper Tower, Klassic ONE
Tibial Sizer and Trial, Klassic ONE
Tibial Low Profile Cut Block, Klassic ONE, Left
Tibial Broach Guide, Klassic ONE
Intramedullary Rod, Klassic ONE
Tibial Alignment Guide Upper Tower, 0 degree, Klassic ONE
AP Sizer, Klassic ONE
Pin Driver, Triangle
Tibial Alignment Guide Lower Tower, Klassic ONE, Ankle Strap
Tibial Insert Trial, PS-Max, Klassic ONE
Contoura Femoral Head Trial
Distal Femoral Cut Guide, Fixed
Patella Caliper, Klassic ONE
Fixed Distal Femoral Cut Guide, Klassic ONE
Flexion/ Extension Cut Block, Klassic ONE
Tibial Insert Trial, CR, Klassic ONE
Tibial Insert Trial, PS-Post, Klassic ONE
Universal Cut Block, Klassic ONE
PS-Post Box Trial, Klassic ONE
Tibial Alignment Guide Upper Tower, 6 degree, Klassic ONE
Tibial Stylus, Klassic ONE
3.2mm Stop Drill
Rotating Distal Femoral Cut Guide, Klassic ONE
Femoral Trial, PS-Post/ Revision, Klassic ONE
Tibial Alignment Guide 0 degrees Spike Upper Tower, Klassic ONE
Tibial Alignment Guide Lower Tower, Klassic ONE
Angel Wing, Klassic ONE
Modular Slap Hammer Rod, Klassic ONE
Tibial Alignment Guide Upper Tower, 3 degree, Klassic ONE
Tibial Baseplate Trial, Pegs, Klassic ONE
Varus/ Valgus Cut Block, Klassic ONE
Modular Handle/ Alignment Guide, Klassic ONE
Tibial Ream Guide, Klassic ONE, 25/50mm
Patella Sizer/ Clamp/ Drill Guide, Klassic ONE, Tip
Patella Cement Clamp, Klassic ONE, Tip
AP Sizer, Klassic ONE, Pegless
Tibial Low Profile Cut Block, Klassic ONE, Right
Tibial Alignment Guide 3 degrees Spike Upper Tower, Klassic ONE
Femoral Shift Block
Guide Pin, Triangle Head, 76mm
Femoral Cut Block, Central Capture, Klassic ONE
Platform® Acetabular Cup Sizers
Platform® Hooded Acetabular Insert Trials
Distal Femoral Augment Trial
Posterior Femoral Augment Trial
Universal Cone Trial
Platform® Neutral Acetabular Insert Trials
Femoral Stem Adapter Trial
Revision Tibial Baseplate Sizer and Trial
Intramedullary Resection Guide Adapter
Femur Trial/Stem Trial Adapter
Tibial Resection Tower
Femoral Stem Adapter Reamer Guide
Femoral Assembly Cradle
Femoral Augment Alignment Guide
Acetabular Reamer Adapter
Stem Trial
Tibial Sizer Resection Guide Adapter
Distal Femoral Cut Guide with Short Pins
Augment Trial, Tibial
Modular Frog Eyes
Klassic Sombrero Patellas
Klassic HD® Femoral Head Adapter Sleeve
Klassic HD® Cancellous Bone Screw
Klassic HD® Acetabular Insert XLPE
Klassic HD® Femoral Stem, Nonporous
Klassic HD® Acetabular Cup w/Ti-Coat
Klassic HD® Femoral Stem, Porous
Klassic HD® Femoral Head
Klassic HD® Acetabular Insert
Klassic Femoral Augment, Distal
Klassic Femoral Augment, Posterior
Klassic Femoral Augment Screw, Posterior
Klassic Tibial Augment
Klassic Stem Adapter, Femoral
Klassic Femoral Augment Screw, Distal
Universal Cone
Klassic Stem Extension, Cemented
Notched Femur Impactor, PS-Post
Femoral Stem Impactor with Anteversion
Femur/Tibia Implant Impactor Handle
Femur Extractor/Impactor
Curved Acetabular Cup Impactor
Modular Knee Impactor Head, Universal
Femur Extractor/Impactor Head
Acetabular Insert Impactor
Modular Liner Impactor Head
Modular Knee Impactor Head, All-Poly
Tibial Impactor Head
Femoral Head Impactor
Universal Impactor Head
Universal Cone Impactor Head
Tibial Broach Impactor, Revision
All-Poly Tibial Impactor Head
Notched Femur Impactor
Curved Acetabular Cup Impactor Ball Hex Driver
Modular Hip Impactor Head, Femoral Head
Modular Knee Impactor Head, Femur
Blade Femoral Stem Impactor, Ball Tip
Blade Femoral Stem Impactor, Angled Tip
Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert
Klassic Knee Instrument Set Sterilization Cases
Klassic HD Hip Instrument Set Sterilization Cases
Klassic HD Hip Offset Instrument Set Sterilization Case
Klassic BiPolar Instrument Set Sterilization Case
Klassic ONE Knee CR/Ultra PS Auxiliary Instrumentation Tray
Klassic ONE Knee CR/Ultra PS Primary Instrumentation Tray
PS-Post Knee Instrument Set
Klassic ONE Knee PS-Post Auxiliary Instrumentation Tray
Klassic ONE Knee PS-Post Primary Instrumentation Tray
Klassic® ONE, CR/Ultra-PS, PS-Post Conversion Instrumentation Tray
Klassic ONE Universal Cone & Revision Baseplate Tray
Klassic Knee PS-Max, Stems/Augments Instrumentation Tray
Universal Cone System Instrument Case
Klassic ONE Universal Cone & Revision Baseplate Tray, Pin Mat Insert
Intermedullary Reamer, Revision
Intramedullary Reamer
Cone Reamer Guide
Distal Hip Reamer
Modular Cone Reamer, Handle
Modular Cone Reamer, Handle Sleeve
Canal Finder Reamer
Universal Cone Reamer, Basket
Tibial Stem Extension Reamer, Combined Size 100 and 150mm
Tibial Reamer, Klassic ONE
Tibial Stem Extension Reamer
Hemispherical Acetabular Reamer
PS-Post Box Reamer, Trephine
PS-Post Box Reamer, Trephine, Klassic ONE
Femoral Head Adaptor Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
Klassic Blade Femoral Stem, Porous
Klassic Blade Offset Femoral Stem, Porous
Klassic® Tibial Baseplate, Revision, Cemented
Klassic® Femurs with Cobalt 3D
Klassic® Tibial Baseplates with Ti-Coat®
3.2mm Drill
8mm Drill
Femur/Patella Peg Drill
3.2mm Drill with Stop
3.2mm Drill Tip
3-in-1 Drill
Klassic HD Hip System, Offset Femoral Stem, Non-porous
Klassic HD Hip System, Offset Femoral Stem, Porous
Klassic Tibial Stem Extensions
PLATFORM® ACETABULAR CUP WITH TI-COAT®
PLATFORM® ACETABULAR INSERT, NEUTRAL, E-LINK POLY
PLATFORM® ACETABULAR INSERT, HOODED, E-LINK POLY
Femoral Broach
All-Poly Tibial Broach, Klassic ONE
Modular Tibial Broach, Klassic ONE
Tibial Broach Stem, Starter
Revision Modular Tibial Broach
All-Poly Tibial Broach Tower Assembly
Klassic Blade Femoral Broach
Klassic HD Modular Femoral Broach
Tibial Broach Stem
Anterior Starter Broach
Klassic Femur, Nonporous, size 7
Klassic Knee Tibial Baseplate
Klassic Knee Domed Patella
Klassic Knee Femur, Nonporous
Klassic Knee Tibial Set Screw
Klassic Knee Tibial Dome Extension
Klassic Knee Tibial Insert, Ultra-PS
Klassic Knee Tibial Insert, CR/Congruent
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198