MAXX ORTHOPEDICS INC.
Registration 3007311878FEI 3007311878Norristown, PA
Owner/operator: Maxx Orthopedics Inc.
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Remanufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 55
- Added, last 12 months
- 17
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 55
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| OQG | Libertas HipHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class 2 | 21 CFR 888.3358 | K192989 |
| OQI | Libertas HipHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class 2 | 21 CFR 888.3353 | K192989 |
| OQI | Libertas Keystone Hip StemHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedAdded Jan 20, 2026 | Class 2 | 21 CFR 888.3353 | K253171 |
| KWY | Libertas Bipolar HipProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | 21 CFR 888.3390 | K243634 |
| KWY | Libertas HipProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | 21 CFR 888.3390 | K163081 |
| KWY | Libertas HipProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | 21 CFR 888.3390 | K133370 |
| LZO | Libertas HipProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | 21 CFR 888.3353 | K183365 |
| LZO | Libertas Keystone Hip StemProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedAdded Jan 20, 2026 | Class 2 | 21 CFR 888.3353 | K253171 |
| LZO | Libertas HipProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | 21 CFR 888.3353 | K192989 |
| LZO | Libertas HipProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | 21 CFR 888.3353 | K133370 |
| LZO | Libertas HipProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | 21 CFR 888.3353 | K183684 |
| LZO | Libertas HipProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | 21 CFR 888.3353 | K180973 |
and 43 more on your full dossier
What changed
- Jan 20, 2026Listing added: OQI — Libertas Keystone Hip Stem (K253171)
- Jan 20, 2026Listing added: LZO — Libertas Keystone Hip Stem (K253171)
- Jan 20, 2026Listing added: MEH — Libertas Keystone Hip Stem (K253171)
- Dec 19, 2025Listing added: MBH — Freedom Metaphyseal Cones (K252777)
- Dec 19, 2025Listing added: JWH — Titan PCK Components (K253144)
- Dec 19, 2025Listing added: JWH — Freedom Metaphyseal Cones (K252777)
- Mar 5, 2026Listing added: HWR — Freedom Driver
- Mar 5, 2026Listing added: GFC — Freedom Pin
- Mar 5, 2026Listing added: HTP — Freedom File
- Mar 5, 2026Listing added: HXE — Freedom Fork
- Dec 31, 2025Listing added: KQX — TracPatch Knee
- Mar 3, 2026Listing added: FZX — Freedom
- Mar 5, 2026Listing added: FZY — Freedom Hammer
- Mar 5, 2026Listing added: HTC — Freedom Pliers
- Apr 27, 2026Listing added: HWD — Freedom Bone Screw
- Mar 5, 2026Listing added: FTY — Freedom Caliper
- Mar 5, 2026Listing added: FSM — Freedom Surgical Tray