Taperloc® Complete Hip Stems
FDA 510(k) K200196 · Biomet Orthopedics
510(k) numberK200196
Submission
- Device name
- Taperloc® Complete Hip Stems
- Applicant
- Biomet Orthopedics
Warsaw, IN, US - Received
- January 27, 2020
- Decision date
- December 8, 2020
- 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 |
|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | 08/24/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | 04/15/2026SE |
| K243761 | A.L.P.S. Small Fragment Plating SystemHRS · Traditional | 02/19/2025SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | 07/12/2023SE |
| K131393 | Mak Oss Femoral Knee ComponentsKRO · Traditional | 10/24/2013SE |
| K112905 | Compress(R) Segmental Humeral Replacement SystemMBF · Traditional | 05/24/2012SE |
| K080528 | E-Poly Tibial BearingsJWH · Traditional | 06/17/2008SE |
| K072879 | Innervue Diagnostic Scope SystemHRX · Traditional | 01/14/2008SE |
| K070955 | Acid Etched Lag ScrewsHSB · Traditional | 10/12/2007SE |
| K033355 | Lactoscrew Screw AnchorHWC · Traditional | 06/30/2004SE |
Questions and answers
When was Taperloc® Complete Hip Stems cleared by the FDA?
Taperloc® Complete Hip Stems (K200196) received a 510(k) decision of Substantially Equivalent on December 8, 2020, 316 days after the submission was received.
What is the product code of K200196?
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.