Fitmore® Hip Stem
FDA 510(k) K170072 · Zimmer GmbH
510(k) numberK170072
Submission
- Device name
- Fitmore® Hip Stem
- Applicant
- Zimmer GmbH
Winterthur, CH - Received
- January 9, 2017
- Decision date
- February 7, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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| K253357 | b-ONE® Bipolar HeadKWY · Traditional | B-One Ortho, Corp. | 04/13/2026SE |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY · Traditional | Maxx Orthopedics, Inc. | 08/25/2025SE |
| K231526 | CORAIL Cemented Femoral StemKWY · Traditional | Depuy Ireland UC | 12/19/2023SE |
| K223441 | SpaceFlex Acetabular CupKWY · Traditional | G21, S.R.L. | 03/23/2023SE |
| K221794 | Vario-Cup SystemKWY · Special | Waldemar Link GmbH & Co. KG | 07/20/2022SE |
| K220492 | COPAL exchange G hip spacerKWY · Special | Heraeus Medical GmbH | 03/23/2022SE |
| K200709 | Kyocera Bipolar Hip SystemKWY · Special | Kyocera Medical Technologies, Inc. | 04/17/2020SE |
| K192236 | Fitmore Hip StemKWY · Special | Zimmer GmbH | 11/05/2019SE |
| K191016 | COPAL exchange G Hip and Knee SpacersKWY · Traditional | Heraeus Medical GmbH | 11/01/2019SE |
| K191297 | iNSitu Bipolar Hip SystemKWY · Traditional | Theken Companies, LLC | 09/17/2019SE |
More from Theken Companies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | 06/16/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | 06/16/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | 05/28/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | 04/27/2026SE |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | 04/13/2026SE |
| K253566 | Affixus Retrograde Femoral Nailing SystemHSB · Traditional | 03/12/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | 03/09/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | 02/04/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | 08/11/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | 07/18/2025SE |
Questions and answers
When was Fitmore® Hip Stem cleared by the FDA?
Fitmore® Hip Stem (K170072) received a 510(k) decision of Substantially Equivalent on February 7, 2017, 29 days after the submission was received.
What is the product code of K170072?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.