Consensus Hip System, Unisyn Hip System
FDA 510(k) K030151 · Hayes Medical, Inc.
510(k) numberK030151
Submission
- Device name
- Consensus Hip System, Unisyn Hip System
- Applicant
- Hayes Medical, Inc.
El Dorado Hills, CA, US - Received
- January 15, 2003
- Decision date
- April 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | 01/31/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | 12/21/2006SE |
| K060635 | Consensus Acetabular Shell SystemLPH · Special | 04/28/2006SE |
| K030205 | Consensus Unipolar Head, CocrKWL · Traditional | 04/01/2003SE |
| K021466 | Consensus Acetabular Insert, Cross-Linked PolyethyleneLPH · Traditional | 07/24/2002SE |
| K020153 | Consensus Acetablar Shell, Ti CoatedLPH · Traditional | 04/15/2002SE |
| K003649 | Triton Hip SystemLWJ · Traditional | 02/23/2001SE |
| K001456 | Consensus Knee SystemJWH · Traditional | 08/07/2000SE |
| K983004 | Consensus Femoral Component, Porous, Cocr/TiJWH · Traditional | 11/25/1998SE |
| K964395 | Patient Specific Implant (Psi) Hip Femoral ComponentLZO · Traditional | 01/27/1997SE |
Questions and answers
When was Consensus Hip System, Unisyn Hip System cleared by the FDA?
Consensus Hip System, Unisyn Hip System (K030151) received a 510(k) decision of Substantially Equivalent on April 10, 2003, 85 days after the submission was received.
What is the product code of K030151?
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.