Headloc Ceramic Femoral Heads
FDA 510(k) K971435 · Ortho Development Corp.
510(k) numberK971435
Submission
- Device name
- Headloc Ceramic Femoral Heads
- Applicant
- Ortho Development Corp.
Draper, UT, US - Received
- April 18, 1997
- Decision date
- July 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | 12/19/2025SE |
| K251052 | Trivicta® Hip StemMEH · Traditional | 05/22/2025SE |
| K242984 | BKS Revision SystemJWH · Special | 10/25/2024SE |
| K242833 | Legend® Acetabular ShellLPH · Special | 10/11/2024SE |
| K233758 | Trivicta Hip StemMEH · Traditional | 03/08/2024SE |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial InsertJWH · Special | 10/25/2023SE |
| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | 12/21/2021SE |
| K211471 | Balanced Knee System UniHSX · Traditional | 12/16/2021SE |
| K203023 | Pisces Spinal SystemNKB · Traditional | 07/14/2021SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | 03/31/2020SE |
Questions and answers
When was Headloc Ceramic Femoral Heads cleared by the FDA?
Headloc Ceramic Femoral Heads (K971435) received a 510(k) decision of Substantially Equivalent on July 9, 1997, 82 days after the submission was received.
What is the product code of K971435?
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.