Hipstar Femoral Stem
FDA 510(k) K051223 · Stryker Orthopaedics
510(k) numberK051223
Submission
- Device name
- Hipstar Femoral Stem
- Applicant
- Stryker Orthopaedics
Mahwah, NJ, US - Received
- May 12, 2005
- Decision date
- May 10, 2006
- 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 |
|---|---|---|
| K211703 | Insignia Hip StemMEH · Traditional | 08/16/2021SE |
| K191414 | EXETER Centralizer, EXETER 2.5mm PlugJDI · Traditional | 08/28/2019SE |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsJDG · Traditional | 03/19/2018SE |
| K173849 | Triathlon Total Knee SystemMBH · Traditional | 02/02/2018SE |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemJWH · Traditional | 10/30/2017SE |
| K153345 | Stryker Orthopaedics Hip Systems Labeling UpdateLPH · Traditional | 05/25/2016SE |
| K151264 | Restoration Anatomic ShellLPH · Traditional | 08/10/2015SE |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…LPH · Traditional | 02/09/2015SE |
| K143393 | Triathlon Tritanium Cone AugmentsMBH · Traditional | 01/13/2015SE |
| K142462 | Restoration Anatomic ShellLPH · Traditional | 11/14/2014SE |
Questions and answers
When was Hipstar Femoral Stem cleared by the FDA?
Hipstar Femoral Stem (K051223) received a 510(k) decision of Substantially Equivalent on May 10, 2006, 363 days after the submission was received.
What is the product code of K051223?
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.