Kinamed Cemented CTH Stem
FDA 510(k) K902074 · Kinamed, Inc.
510(k) numberK902074
Submission
- Device name
- Kinamed Cemented CTH Stem
- Applicant
- Kinamed, Inc.
Newbury Park, CA, US - Received
- May 7, 1990
- Decision date
- June 8, 1990
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| K122049 | Neuropro Low Profile Cranial Plating SystemGWO · Traditional | 04/05/2013SE |
| 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 Cemented CTH Stem cleared by the FDA?
Kinamed Cemented CTH Stem (K902074) received a 510(k) decision of Substantially Equivalent for Some Indications on June 8, 1990, 32 days after the submission was received.
What is the product code of K902074?
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.