# K070267: Depuy GCK Tibial Components

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 17, 2007 after 200 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943462 (1994). 12 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061648: Depuy Graduated Compartmental Knee (GCK), DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K040268: Depuy Preservation Unicondylar Tibia, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K910968: P.F.C. Unicondylar Knee System, Johnson & Johnson Orthopaedics, Inc. (1991) Summary page 1.

## Most influential descendants
- K093056: Smith & Nephew, Inc. Journey Select Knee System (2009), 9 descendants of its own
- K160738: ZUK Select Knee System (2016), 8 descendants of its own
- K190085: Journey II Unicompartmental Knee System (2019), 7 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K191211: JOURNEY II Unicompartmental Knee System (2019), 1 descendant of its own

## Indications for use
The Sigma High Performance Unity Knee Resurfacing System 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 Sigma High Performance Unity Knee Resurfacing System components are intended for CEMENTED USE ONLY.

Source page: https://510kreport.com/device/K070267
Methodology: https://510kreport.com/methodology