SLT Femoral Head
FDA 510(k) K932222 · Dow Corning Wright
510(k) numberK932222
Submission
- Device name
- SLT Femoral Head
- Applicant
- Dow Corning Wright
Arlington, TN, US - Received
- May 7, 1993
- Decision date
- May 27, 1994
- 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 |
|---|---|---|
| K932210 | Ortholoc Advantim Revision Femoral ComponentJWH · Traditional | 09/07/1994SN |
| K932911 | Ortholoc Advantim L.S. Tibial ComponentJWH · Traditional | 06/30/1994SN |
| K934354 | Lacey All Polyethylene Tibial ComponentJWH · Traditional | 06/03/1994SE |
| K932858 | Ortholoc Advantim Tibial Base ComponentJWH · Traditional | 02/16/1994SE |
| K930228 | Ortholoc Advantim Tibial Stem 5 DegreeJWH · Traditional | 11/30/1993SE |
| K925900 | Lacey Revision Femoral ComponentJWH · Traditional | 08/24/1993SE |
| K930189 | Ortholoc(R) Advantim(Tm) Posterior Stab Femor CompJWH · Traditional | 08/06/1993SN |
| K930188 | Ortholoc(R) Advantim(Tm) Femoral ComponentJWH · Traditional | 08/03/1993SE |
| K930190 | Ortholoc(R) Advantim(Tm) Non-Por Coat Femor CompJWH · Traditional | 08/02/1993SE |
| K926257 | Ortholoc Advantim Thick Tibial Base ComponentJWH · Traditional | 05/18/1993SE |
Questions and answers
When was SLT Femoral Head cleared by the FDA?
SLT Femoral Head (K932222) received a 510(k) decision of Substantially Equivalent on May 27, 1994, 385 days after the submission was received.
What is the product code of K932222?
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.