Kinamed 32MM Bioceram-Z Toatal Hip Femoral Ball
FDA 510(k) K920290 · Kinamed, Inc.
510(k) numberK920290
Submission
- Device name
- Kinamed 32MM Bioceram-Z Toatal Hip Femoral Ball
- Applicant
- Kinamed, Inc.
Newbury Park, CA, US - Received
- January 22, 1992
- Decision date
- November 3, 1992
- 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
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|---|---|---|---|
| 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 |
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| K102834 | Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)JDQ · Special | 01/12/2011SE |
| K072250 | Supercable Grip and Plate SystemKTT · Traditional | 11/09/2007SE |
| K050897 | Navipro Shoulder Software ModuleHAW · Traditional | 05/24/2005SE |
| K033668 | Navipro Knee Software ModuleHAW · Traditional | 03/11/2004SE |
| K032950 | Gem Inset Patellar ComponentJWH · Traditional | 12/19/2003SE |
| K030256 | Iso-Elastic Cerclage SystemJDQ · Traditional | 10/21/2003SE |
| K020764 | NaviproHAW · Traditional | 06/03/2002SE |
| K013982 | Kinematch Patello-Femoral Resurfacing ImpalantKRR · Traditional | 05/21/2002SE |
Questions and answers
When was Kinamed 32MM Bioceram-Z Toatal Hip Femoral Ball cleared by the FDA?
Kinamed 32MM Bioceram-Z Toatal Hip Femoral Ball (K920290) received a 510(k) decision of Substantially Equivalent on November 3, 1992, 286 days after the submission was received.
What is the product code of K920290?
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.