# K091196: GRS Glenoid Resurfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Oct 27, 2009 after 187 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- 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 K800494 (1980). 28 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 2.
- K060694: Modular Hybrid Glenoid, Biomet Manufacturing Corp (2006) Summary page 2.
- K072578: Synthes (Usa) Epoca Shoulder Prosthesis System, Synthes (Usa) (2007) Summary page 2.

## Most influential descendants
- K202716: Ignite Anatomic Shoulder System (2021), 13 descendants of its own
- K212737: INHANCE™ Reverse Shoulder System (2022), 9 descendants of its own
- K152825: Catalyst CSR Shoulder System (2016), 7 descendants of its own
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K181287: Catalyst CSR Shoulder System (2018), 3 descendants of its own

## Indications for use
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

Source page: https://510kreport.com/device/K091196
Methodology: https://510kreport.com/methodology