Zimmer Zirconia Ceramic Femoral Head
FDA 510(k) K955877 · Zimmer, Inc.
510(k) numberK955877
Submission
- Device name
- Zimmer Zirconia Ceramic Femoral Head
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- December 26, 1995
- Decision date
- October 8, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | 06/16/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | 06/16/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | 05/28/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | 04/27/2026SE |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | 04/13/2026SE |
| K253566 | Affixus Retrograde Femoral Nailing SystemHSB · Traditional | 03/12/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | 03/09/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | 02/04/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | 08/11/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | 07/18/2025SE |
Questions and answers
When was Zimmer Zirconia Ceramic Femoral Head cleared by the FDA?
Zimmer Zirconia Ceramic Femoral Head (K955877) received a 510(k) decision of Substantially Equivalent for Some Indications on October 8, 1996, 287 days after the submission was received.
What is the product code of K955877?
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.