Corin MetaFix Hip Stem
FDA 510(k) K212069 · Corin U.S.A. Limited
510(k) numberK212069
Submission
- Device name
- Corin MetaFix Hip Stem
- Applicant
- Corin U.S.A. Limited
Tampa, FL, US - Received
- July 2, 2021
- Decision date
- April 7, 2022
- 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 |
|---|---|---|
| K242744 | Trinity EVO Acetabular ShellLPH · Traditional | 06/05/2025SE |
| K241808 | ApolloHipX (THR.SS.0001)LLZ · Traditional | 01/07/2025SE |
| K241472 | Icona Hip StemMEH · Traditional | 10/03/2024SE |
| K241570 | Unity Total Knee SystemJWH · Traditional | 09/23/2024SE |
| K240875 | Unity Knee PS-C Tibial InsertJWH · Traditional | 06/26/2024SE |
| K231172 | ApolloKneeOLO · Traditional | 07/26/2023SE |
| K191831 | MobiliT CupLZO · Traditional | 01/16/2020SE |
| K191374 | Revival Modular Hip StemLZO · Traditional | 07/22/2019SE |
| K183114 | Corin BiPolar-iKWY · Traditional | 06/05/2019SE |
| K183533 | Unity Total Knee SystemJWH · Traditional | 06/04/2019SE |
Questions and answers
When was Corin MetaFix Hip Stem cleared by the FDA?
Corin MetaFix Hip Stem (K212069) received a 510(k) decision of Substantially Equivalent on April 7, 2022, 279 days after the submission was received.
What is the product code of K212069?
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.