ceramys femoral head system
FDA 510(k) K241483 · Encore Medical L.P.
510(k) numberK241483
Submission
- Device name
- ceramys femoral head system
- Applicant
- Encore Medical L.P.
Austin, TX, US - Received
- May 24, 2024
- Decision date
- February 7, 2025
- 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 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional | Maxx Orthopedics, Inc. | 01/15/2026SE |
| 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 |
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|---|---|---|
| K252567 | AltiVate Reverse® ADLC GlenospherePHX · Traditional | 01/15/2026SE |
| K252974 | EMPOWR KneeJWH · Traditional | 12/19/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | 11/12/2025SE |
| K252141 | AltiVate Reverse® GlenoidPHX · Special | 08/05/2025SE |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)JWH · Special | 07/08/2025SE |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)JWH · Traditional | 07/02/2025SE |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…PHX · Special | 05/16/2025SE |
| K233481 | AltiVate Reverse® GlenoidPHX · Traditional | 05/29/2024SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | 06/23/2023SE |
| K213387 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Traditional | 07/07/2022SE |
Questions and answers
When was ceramys femoral head system cleared by the FDA?
ceramys femoral head system (K241483) received a 510(k) decision of Substantially Equivalent on February 7, 2025, 259 days after the submission was received.
What is the product code of K241483?
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.