FDA Registration
Active
🇺🇸 United States
MICROPORT ORTHOPEDICS INC.
Reg #: 3010536692
·
FEI: 3010536692
·
Expires 2026
Products
106
Proprietary Names
175
Establishment Types
7
Classifications
106
Registration Details
- Registration Name
- MICROPORT ORTHOPEDICS INC.
- Registration Number
- 3010536692
- FEI Number
- 3010536692
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5677 AIRLINE RD
- City
- Arlington
- State
- TN
- ZIP
- 38002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K926334
- PMA Number
- P030042
Owner / Operator
- Firm Name
- MicroPort Orthopedics Inc.
- Operator Number
- 10045253
- Address
- 5677 Airline Road
- City
- Arlington
- State
- TN
- Postal Code
- 38002
- Country
- US
- Correspondent
- Ryan Ross
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2014-02-02 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2014-02-02 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2014-02-02 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2014-02-03 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2014-02-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2014-02-02 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2014-02-02 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2014-02-02 |
| Cap, Bone | JDT | Class 1 | Orthopedic | No | 2014-02-03 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2014-08-14 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2014-02-01 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2014-02-02 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2014-02-02 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2014-02-02 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2020-12-17 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2014-02-03 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2023-10-16 |
| Prosthesis, Hip, Femoral, Resurfacing | KXA | Class 2 | Orthopedic | No | 2014-02-02 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2014-02-03 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2019-11-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | NXT | Class 3 | Unknown | No | 2014-02-02 |
| Template | HWT | Class 1 | Orthopedic | No | 2014-02-03 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2014-02-03 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2014-02-02 |
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | No | 2014-02-02 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2014-01-28 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-08-31 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2021-08-31 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2014-02-03 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2014-02-03 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2014-02-03 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2014-02-03 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2015-04-30 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2014-02-03 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2014-02-03 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2025-05-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-07-27 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2014-02-03 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2014-02-03 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Bender | HXW | Class 1 | Orthopedic | No | 2014-02-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented | LPF | Class 3 | Unknown | No | 2014-09-12 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-10-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2014-02-03 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2017-07-19 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2014-02-03 |
| Applier, Cerclage | HXN | Class 1 | Orthopedic | No | 2014-02-03 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2014-02-03 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2014-02-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | MRA | Class 3 | Unknown | No | 2014-02-11 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2014-02-04 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2014-02-02 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2014-02-01 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2014-02-03 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2019-11-20 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2014-02-03 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2014-02-03 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2014-02-03 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2014-02-03 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2014-02-01 |
| Probe | HXB | Class 1 | Orthopedic | No | 2014-02-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-02-03 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2022-02-07 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2014-02-03 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2014-02-03 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2014-02-03 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2014-02-03 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2014-02-03 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2014-02-03 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2014-02-03 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2014-01-18 |
| Skid, Bone | HWO | Class 1 | Orthopedic | No | 2014-02-03 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Prosthesis, Knee, Hinged (Metal-Metal) | HRZ | Class 3 | Orthopedic | No | 2014-02-02 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2014-02-02 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2014-02-02 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2014-02-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2014-02-03 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2019-11-20 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Tracheotome | LJW | Class 1 | Ear, Nose, Throat | No | 2014-02-02 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2014-02-03 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2014-02-03 |
| File | HTP | Class 1 | Orthopedic | No | 2014-02-03 |
Proprietary Names
EXTRACTOR
Impactor
Bone Cap
OSTEOTOME
SAW
Profemur Gladiator Cemented Classic Stem
Powered Accessory
osteotome
Evolution
retractor
EVOLUTION® Hinge Knee System
BIOLOX Delta Option Heads and Sleeves
BIOLOX Delta Option XL Heads
Awl
Forceps
ETIBCK00 - EVOLUTION® TIBIAL CEMENT KEEL
Conserve
Superpath
Odyssey
Template
Pusher
Bipolar Shell
18951018 ADVANTIM® POST STAB FEM LG LEFT NONPOROUS OPEN HOUSING
Dynasty Additive Manufacturing Shells
Prime Additive Manufacturing Shells
E1204403 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 3
ES01TR13 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY 3
E1204404 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 4
E2102007 EVOLUTION® TIBIA EM MOUNTED STABILIZER
E1503030 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 0MM
ES01TR11 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY
E1503024 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 4MM
ES011040 EVOLUTION® KA CADDY CLASSIC GAP SPACERS
E1503011 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 1MM
E1503034 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 4MM
E1503022 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 2MM
E1503023 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 3MM
ES00TR13 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY 3
E1501010 EVOLUTION® KA IM DISTAL FEM ALIGNMENT GUIDE W/ ADJ PADS
E1500030 EVOLUTION® KA EM ADJUSTABLE TIBIAL STYLUS
E1503014 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 4MM
E1503025 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 5MM
ES011041 EVOLUTION® KA CADDY DISTAL REF GAP SPACERS
E1501020 EVOLUTION® KA IM ADJUSTABLE VALGUS BUSHING
E1503031 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 1MM
EVOLUTION® Kinematic Alignment Instruments
E1204405 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 5
ES01TR12 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY 2
E150012R EVOLUTION® KA EM TIBIAL SLOTTED SHIM RIGHT
E110041R EVOLUTION® MA DCF POS REF FEM SIZING GUIDE RIGHT
E1500050 EVOLUTION® KA UNIVERSAL THICKNESS CALIPER
E110041L EVOLUTION® MA DCF POS REF FEM SIZING GUIDE LEFT
E1500040 EVOLUTION® KA CARTILAGE THICKNESS GAUGE
E2102008 EVOLUTION® TIBIA EM MOUNTED STABILIZER STRAP
E1502040 EVOLUTION® KA OFFSET EM TIBIAL ROD W/ STOP
E1503033 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 3MM
E1500020 EVOLUTION® KA EM TIBIAL SHIM UNIVERSAL
E1503013 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 3MM
E1502030 EVOLUTION® KA STRAIGHT EM TIBIAL ROD W/ STOP
E1503032 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 2MM
E1500031 EVOLUTION® KA EM ADJUSTABLE TIBIAL STYLUS W/SPOONS
E1503015 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 5MM
E1503035 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 5MM
E1204401 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK MONOLITHIC SIZE 1
E150012L EVOLUTION® KA EM TIBIAL SLOTTED SHIM LEFT
E2102009 EVOLUTION® KA TIBIA EM ANKLE CLAMP ASSEMBLY
E1204406 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 6
ES00TR11 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY
E1204407 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 7
E1500010 EVOLUTION® KA EM TIBIAL RESECTION GUIDE
E1503012 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 2MM
E1204402 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 2
ES00TR12 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY 2
E1100431 EVOLUTION® MA SKI TIP STYLUS FOR AR & PR FEM SIZING GUIDE
E1500060 EVOLUTION® KA RE-DRILL GUIDE SIZE 8
E1503021 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 1MM
EVOLUTION® REV CONE INSERTER (E233CN01-06)
EVOLUTION® REV SPACERS (E5101CN1-4)
EVOLUTION® REV CONE TRIALS (E3500CN1-6)
EVOLUTION® REV CONICAL BROACHES (E223CN01-06)
EVOLUTION® REV CONE EXTRACTOR (E233CN11)
EVOLUTION® REV CONICAL REAMERS (E2432CN01-06)
EVOLUTION® TIBIAL CONES (ETKNCN01-06)
EVOLUTION® REV BROACH ADAPTERS (E203CN01-03)
EVOLUTION® REV REAMER PILOT (E2432CN11-13)
EVOLUTION® REV CEMENT KEEL TRIAL (E3500CK1)
Mill
Trephine
Splint
Broach
goniometer
Bur
Wrench
Twister
Nexus Hip Stem
Prime Acetabular Cup System
STARTER, BONE SCREW
Hammer
AXIOM® Second Generation Knee System
Serrated Clip
Suture Button
Bender
Procotyl
Biolox
clamp
Reamer
Advance
Dynasty
General Use Manual Instrument
PROFEMUR® Preserve Sizes 1-3 Hip Stems
Compression Instrument
EVOLUTION REVISION CCK
Applier, Cerclage
BIT, DRILL
Punch
Profemur
PROFEMUR® TL Classic Long Neck Hip Stems
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
EVOLUTION Stemmed CS Femur
18711131 STRYKER SAW BLADE 2000 NARROW STERILE
18711133 HALL 7 HOLE SAW BLADE NARROW
18711132 STRYKER SAW BLADE 2000 WIDE STERILE
Brace, Drill
Advantim
Passer
Caliper
Pliers
chisel
Planar
rasp
PROCOTYL® L-O Acetabular System
ADVANCE® Double High Insert
Tap
Tamp
Probe
Manual Surgical Instrument
Elevator
Profemur Preserve Classic
REPIPHYSIS® Limb Salvage System
Profemur Gladiator Thin HA Classic Stems with Collar
Screwdriver
Stripper
PROFEMUR Renaissance Classic Long Neck Hip Stems
KNIFE, ORTHOPEDIC
Driver
Passer, Wire
PROFEMUR Z
RONGEUR
Mallet
Depth Gauge
ring cutter
Skid
RASP
guide
Spatula
Scissors
Interseal
Perfecta
Guardian
Transcend
Path
Lineage
tape, measuring
Prosthesis, hip, semi-constrained (metal cemented acetabular component
Cutter
Chisel
CANCELLOUS BONE SCREW
MicroPort CoCr Femoral Heads
saw blade
Axiom
Dynasty Dual Mobility System
drill bit
Countersink
File
EVOLUTION® BIOFOAM® Tibial System ADVANCE® BIOFOAM® Tibia
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Reprocess Single-Use Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198