Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
FDA 510(k) K253171 · Maxx Orthopedics, Inc.
510(k) numberK253171
Submission
- Device name
- Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
- Applicant
- Maxx Orthopedics, Inc.
Norristown, PA, US - Received
- September 26, 2025
- Decision date
- January 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | United Orthopedic Corporation | 09/02/2026SE |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | Waldemar Link GmbH & Co. KG | 07/06/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | Zimmer, Inc. | 06/16/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | Zimmer, Inc. | 04/27/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | Implantcast GmbH | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | Implantcast GmbH | 03/12/2026SE |
| K250450 | Coated hip implantsLZO · Traditional | Medacta International S.A. | 09/19/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | Signature Orthopaedics Pty, Ltd. | 08/07/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | Zimmer, Inc. | 07/18/2025SE |
| K251292 | RECLAIM Monobloc Revision Femoral StemLZO · Special | Depuy Ireland UC | 05/23/2025SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | 08/07/2026SE |
| K261609 | Freedom Partial Knee SystemHSX · Traditional | 08/04/2026SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | 10/31/2025SE |
| K253314 | Freedom Infinia Total Knee SystemJWH · Special | 10/29/2025SE |
| K253144 | Freedom® Total Knee System Titan PCK ComponentsJWH · Special | 10/22/2025SE |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY · Traditional | 08/25/2025SE |
| K251717 | Freedom® Total Knee System Titanium Tibial Base PlateJWH · Special | 06/26/2025SE |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate)JWH · Special | 03/13/2025SE |
| K241597 | Freedom® Total Knee System - Porous Tibial Base PlateMBH · Traditional | 02/13/2025SE |
| K243277 | Freedom® Medial Congruent LinerJWH · Special | 11/19/2024SE |
Questions and answers
When was Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) cleared by the FDA?
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (K253171) received a 510(k) decision of Substantially Equivalent on January 15, 2026, 111 days after the submission was received.
What is the product code of K253171?
The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.