Depuy Graduated Compartmental Knee (GCK)
FDA 510(k) K061648 · DePuy Orthopaedics, Inc.
510(k) numberK061648
Submission
- Device name
- Depuy Graduated Compartmental Knee (GCK)
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- June 13, 2006
- Decision date
- September 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPJ – Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Other 510(k)s with product code NPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150307 | RESTORIS Multicompartmental Knee SystemNPJ · Special | Mako Surgical Corp. | 03/10/2015SE |
| K133039 | Restoris Multicompartmental Knee SystemNPJ · Special | Mako Surgical Corporation | 12/10/2013SE |
| K093513 | Iduo Bicompartmental Knee Repair SystemNPJ · Special | Conformis, Inc. | 12/16/2009SE |
| K093056 | Smith & Nephew, Inc. Journey Select Knee SystemNPJ · Traditional | Smith & Nephew, Inc. | 12/15/2009SE |
| K090763 | Restoris Multicompartmental Knee (MCK) SystemNPJ · Traditional | Mako Surgical Corporation | 06/17/2009SE |
| K070849 | Depuy GCK Femoral and Tibial ComponentsNPJ · Traditional | DePuy Orthopaedics, Inc. | 06/26/2007SE |
| K061569 | Smith & Nephew Competitor Deuce Femoral ComponentsNPJ · Special | Smith & Nephew, Inc. | 07/06/2006SE |
| K053488 | Conformis Bicompartmental Knee Repair SystemNPJ · Traditional | Conformis, Inc. | 03/09/2006SE |
| K052917 | Stryker Compartmental Knee SystemNPJ · Traditional | Howmedica Osteonics Corp. | 12/27/2005SE |
| K052265 | Smith & Nephew Competitor Duo Knee FemoralNPJ · Abbreviated | Smith & Nephew, Inc. | 12/27/2005SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | 09/04/2026SE |
| K252887 | DePuy ATTUNE Knee SystemOIY · Traditional | 05/22/2026SE |
| K231503 | CUPTIMIZE AdvancedLLZ · Traditional | 08/22/2023SE |
| K213839 | DePuy Corail AMT Hip ProsthesisLZO · Special | 01/06/2022SE |
| K210167 | DELTA XTEND Reverse Shoulder SystemPHX · Special | 02/19/2021SE |
| K203167 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/19/2020SE |
| K202472 | ACTIS Duofix Hip ProsthesisLPH · Special | 10/21/2020SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | 06/18/2020SE |
| K193540 | TRUMATCH Personalized SolutionsJWH · Traditional | 06/16/2020SE |
| K193398 | Summit DuoFix HA CoatingMEH · Special | 02/04/2020SE |
Questions and answers
When was Depuy Graduated Compartmental Knee (GCK) cleared by the FDA?
Depuy Graduated Compartmental Knee (GCK) (K061648) received a 510(k) decision of Substantially Equivalent on September 11, 2006, 90 days after the submission was received.
What is the product code of K061648?
The FDA product code is NPJ – Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.