MasterLoc Stem
FDA 510(k) K160289 · Medacta International
510(k) numberK160289
Submission
- Device name
- MasterLoc Stem
- Applicant
- Medacta International
Castel San Pietro, CH - Received
- February 3, 2016
- Decision date
- May 20, 2016
- 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 |
|---|---|---|
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | 06/10/2026SE |
| K160605 | MectaLIF Anterior Stand-AloneOVD · Traditional | 07/21/2016SE |
| K153664 | M.U.S.T. Pedicle Screw SystemNKB · Special | 01/19/2016SE |
| K151531 | MasterLoc StemLZO · Traditional | 10/30/2015SE |
| K142744 | Mecta-C TiPEEKODP · Traditional | 05/07/2015SE |
| K143453 | Mpact Double Mobility SystemLPH · Traditional | 03/02/2015SE |
| K142069 | GMK ExtensionJWH · Traditional | 12/02/2014SE |
| K141988 | M.U.S.T Pedicle Screw SystemNKB · Special | 08/19/2014SE |
| K141044 | M.U.S.T. ExtensionNKB · Traditional | 08/18/2014SE |
| K140826 | GMK Sphere ExtensionJWH · Traditional | 07/15/2014SE |
Questions and answers
When was MasterLoc Stem cleared by the FDA?
MasterLoc Stem (K160289) received a 510(k) decision of Substantially Equivalent on May 20, 2016, 107 days after the submission was received.
What is the product code of K160289?
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.