Consensus Acetabular Shell System
FDA 510(k) K060635 · Hayes Medical, Inc.
510(k) numberK060635
Submission
- Device name
- Consensus Acetabular Shell System
- Applicant
- Hayes Medical, Inc.
El Dorado Hills, CA, US - Received
- March 10, 2006
- Decision date
- April 28, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | Encore Medical L.P. | 11/12/2025SE |
More from Encore Medical L.P.
| 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 |
| K030151 | Consensus Hip System, Unisyn Hip SystemLZO · Traditional | 04/10/2003SE |
| 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 Acetabular Shell System cleared by the FDA?
Consensus Acetabular Shell System (K060635) received a 510(k) decision of Substantially Equivalent on April 28, 2006, 49 days after the submission was received.
What is the product code of K060635?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.