FDA Registration
Active
🇺🇸 United States
MAXX ORTHOPEDICS INC.
Reg #: 3007311878
·
FEI: 3007311878
·
Expires 2026
Products
30
Proprietary Names
42
Establishment Types
4
Classifications
30
Registration Details
- Registration Name
- MAXX ORTHOPEDICS INC.
- Registration Number
- 3007311878
- FEI Number
- 3007311878
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2460 General Armistead Ave, Suite 100
- City
- Norristown
- State
- PA
- ZIP
- 19403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251717
Owner / Operator
- Firm Name
- Maxx Orthopedics Inc.
- Operator Number
- 10028575
- Address
- 2460 General Armistead Ave, Suite 100
- City
- Norristown
- State
- PA
- Postal Code
- 19403
- Country
- US
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 | 2025-08-27 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2025-12-19 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2015-10-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-09-03 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2026-03-05 |
| File | HTP | Class 1 | Orthopedic | No | 2026-03-05 |
| Goniometer, Ac-Powered | KQX | Class 1 | Orthopedic | No | 2025-12-31 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2015-10-20 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2023-08-10 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2015-10-20 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2015-10-20 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2026-03-05 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2020-11-04 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2020-11-04 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2026-03-05 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2026-03-05 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-03-05 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2026-03-05 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2015-10-20 |
| Fork | HXE | Class 1 | Orthopedic | No | 2026-03-05 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-03-03 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2014-03-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-10-10 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-07-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-10-20 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2026-04-27 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-07-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2026-01-20 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2015-10-20 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2015-10-20 |
Proprietary Names
Freedom Infinia Titanium Tibial Base Plate
Freedom Titanium Tibial Base Plate
Freedom Metaphyseal Cones
Freedom Knee
Libertas Hip
Freedom All-poly Baseplate
Libertas Driver
Freedom Driver
Infinia Driver
Freedom File
Infinia File
Libertas File
TracPatch Knee
Freedom Infinia Knee
Freedom Porous Tibia
Freedom Partial Knee
Titan PCK Components
Libertas Hammer
Infinia Hammer
Freedom Hammer
Libertas Pin
Freedom Pin
Infinia Pin
Infinia Caliper
Libertas Caliper
Freedom Caliper
Freedom Infinia
Infinia Surgical Tray
Freedom Surgical Tray
Libertas Surgical Tray
Freedom Pliers
Libertas Pliers
Infinia Pliers
Libertas Fork
Freedom Fork
Infinia Fork
Freedom
Infinia
Libertas Bipolar Hip
Freedom Bone Screw
Infinia Bone Screw
Libertas Keystone Hip Stem
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Remanufacture Medical Device