implaFit® hip stems
FDA 510(k) K210678 · Implantcast GmbH
510(k) numberK210678
Submission
- Device name
- implaFit® hip stems
- Applicant
- Implantcast GmbH
Buxtehude, DE - Received
- March 5, 2021
- Decision date
- August 17, 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 |
|---|---|---|
| K252451 | EPORE® XO cup systemOQI · Traditional | 04/24/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | 03/12/2026SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | 03/10/2025SE |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mmLZO · Traditional | 10/24/2024SE |
| K234044 | ACS® LD FB Knee SystemJWH · Traditional | 09/06/2024SE |
| K240834 | EcoFit® short stem cementless cpTiLZO · Traditional | 06/03/2024SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | 02/16/2024SE |
| K232371 | Actinia® hip stemsLZO · Traditional | 10/19/2023SE |
| K223103 | BethaLoc® stem cementless HALZO · Traditional | 06/20/2023SE |
Questions and answers
When was implaFit® hip stems cleared by the FDA?
implaFit® hip stems (K210678) received a 510(k) decision of Substantially Equivalent on August 17, 2022, 530 days after the submission was received.
What is the product code of K210678?
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.