Modification To:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ
FDA 510(k) K051756 · Zimmer Trabecular
510(k) numberK051756
Submission
- Device name
- Modification To:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ
- Applicant
- Zimmer Trabecular
Allendale, NJ, US - Received
- June 29, 2005
- Decision date
- July 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 510(k) | Device | Decision |
|---|---|---|
| K061155 | Vista P Vertebral Body Replacement SystemMQP · Traditional | 09/22/2006SE |
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| 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 |
| 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 Modification To:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ cleared by the FDA?
Modification To:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ (K051756) received a 510(k) decision of Substantially Equivalent on July 27, 2005, 28 days after the submission was received.
What is the product code of K051756?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.