Trabecular Metal Acetabular Augments
FDA 510(k) K061067 · Zimmer Trabecular
510(k) numberK061067
Submission
- Device name
- Trabecular Metal Acetabular Augments
- Applicant
- Zimmer Trabecular
Allendale, NJ, US - Received
- April 17, 2006
- Decision date
- May 25, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K061155 | Vista P Vertebral Body Replacement SystemMQP · Traditional | 09/22/2006SE |
| K053340 | Trabecular Metal Tibial and Femoral Cone AugmentsMBH · Traditional | 02/27/2006SE |
| K052950 | The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemMQP · Special | 11/16/2005SE |
| K051756 | Modification To:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZJWH · Special | 07/27/2005SE |
| K050766 | Explant Osteonecrosis Intervention Implant Removal SystemHWE · Traditional | 05/26/2005SE |
| K050937 | Trabecular Metal Acetabular Revision ShellsLPH · Special | 05/11/2005SE |
| K050101 | The Trabecular Metal Bone Stabilization Implant, Model 99-11197-XX-10HRS · Traditional | 04/15/2005SE |
| K042871 | Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3…LPH · Special | 12/21/2004SE |
| K043061 | The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model…KWS · Special | 11/23/2004SE |
Questions and answers
When was Trabecular Metal Acetabular Augments cleared by the FDA?
Trabecular Metal Acetabular Augments (K061067) received a 510(k) decision of Substantially Equivalent on May 25, 2006, 38 days after the submission was received.
What is the product code of K061067?
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.