Ceramic Ball Heads, 28, 32 and 36 MM
FDA 510(k) K070928 · Plus Orthopedics AG
510(k) numberK070928
Submission
- Device name
- Ceramic Ball Heads, 28, 32 and 36 MM
- Applicant
- Plus Orthopedics AG
Norfolk, MA, US - Received
- April 3, 2007
- Decision date
- August 1, 2007
- 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 |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070731 | Pigalileo Total Hip Replacement (THR) SystemHAW · Traditional | 07/31/2007SE |
| K070278 | Polarcup Dual Mobility SystemLPH · Traditional | 04/16/2007SE |
| K063578 | Promos Modular Shoulder SystemHSD · Traditional | 03/02/2007SE |
| K061362 | Pigalileo Total Knee Replacement (TKR) SystemHAW · Traditional | 10/06/2006SE |
| K032126 | Promos ShoulderHSD · Traditional | 01/08/2004SE |
| K033763 | Modification to Slim Gliding Nail SystemKTT · Special | 12/18/2003SE |
| K032709 | Modular Plus Hip StemLWJ · Special | 09/23/2003SE |
| K032548 | Ip-Xs Compression Nail SystemHSB · Traditional | 09/10/2003SE |
| K032215 | Vks/Tc-Plus Revision KneeJWH · Special | 08/08/2003SE |
| K032052 | Uc-Plus Solution Unicondylar KneeHRY · Special | 07/25/2003SE |
Questions and answers
When was Ceramic Ball Heads, 28, 32 and 36 MM cleared by the FDA?
Ceramic Ball Heads, 28, 32 and 36 MM (K070928) received a 510(k) decision of Substantially Equivalent on August 1, 2007, 120 days after the submission was received.
What is the product code of K070928?
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.