# K193549: SIGMA High Performance (HP) Partial Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Apr 16, 2020 after 118 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: 5 generations back to K943462 (1994). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070849: Depuy GCK Femoral and Tibial Components, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K070267: Depuy GCK Tibial Components, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K061648: Depuy Graduated Compartmental Knee (GCK), DePuy Orthopaedics, Inc. (2006) Summary page 4.
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 4.

## Indications for use
INDICATIONS The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral articular surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

Source page: https://510kreport.com/device/K193549
Methodology: https://510kreport.com/methodology