Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head
FDA 510(k) K971721 · Whiteside Biomechanics, Inc.
510(k) numberK971721
Submission
- Device name
- Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head
- Applicant
- Whiteside Biomechanics, Inc.
Creve Coeur, MO, US - Received
- May 9, 1997
- Decision date
- July 30, 1997
- 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 |
|---|---|---|
| K033313 | Quatro M Femoral ComponentLWJ · Traditional | 07/28/2004SE |
| K012800 | Symmetric Unicompartmental Knee SystemHRY · Traditional | 05/03/2002SE |
| K003618 | Whiteside Biomechanics Low Profile Stainless Steel Cable System, Model BIO-1-1014NDD · Traditional | 05/23/2001SE |
| K993903 | Whiteside Biomechanics Titanium Low-Profile Cable, Model BIO-1-1013JDQ · Traditional | 02/14/2000SE |
| K991678 | Whiteside Biomechanics Spinal SystemKWQ · Traditional | 08/12/1999SE |
| K981238 | Bipolar Femoral HeadKWY · Traditional | 08/21/1998SE |
| K973261 | Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral HeadLZO · Traditional | 11/24/1997SE |
| K964616 | Quatroloc Plasma Sprayed Femoral ComponentLPH · Traditional | 08/07/1997SE |
| K971718 | Micro-Seal Acetabular SystemLPH · Traditional | 07/23/1997SE |
| K964150 | Whiteside Biomechanics Zirconia Ceramic Femoral HeadLZO · Traditional | 12/27/1996SE |
Questions and answers
When was Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head cleared by the FDA?
Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head (K971721) received a 510(k) decision of Substantially Equivalent on July 30, 1997, 82 days after the submission was received.
What is the product code of K971721?
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.