# K061648: Depuy Graduated Compartmental Knee (GCK)

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 11, 2006 after 90 days
- Product code: NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943462 (1994). 8 ancestors in all.
61 later devices descend from it; 6 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052917: Stryker Compartmental Knee System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K010810: Depuy Preservation Unicondylar Knee Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 1.
- K040166: Depuy Sigma XLK Tibial Inserts, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Most influential descendants
- K070849: Depuy GCK Femoral and Tibial Components (2007), 59 descendants of its own
- K082172: Mako Modular Knee Compartmental Implant System (2008), 51 descendants of its own
- K090763: Restoris Multicompartmental Knee (MCK) System (2009), 50 descendants of its own
- K133039: Restoris Multicompartmental Knee System (2013), 26 descendants of its own
- K150307: RESTORIS Multicompartmental Knee System (2015), 25 descendants of its own

## Recalls of this device
- Dec 21, 2017 · Class II · Z-1219-2018: The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market survei

## Indications for use
The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USE ONLY.

Source page: https://510kreport.com/device/K061648
Methodology: https://510kreport.com/methodology