# K031971: Global Cap Resurfacing Replacement Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 24, 2003 after 90 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- 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 K800494 (1980). 8 ancestors in all.
141 later devices descend from it; 9 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010827: Copeland MB/HA Resurfacing Humeral Heads, Biomet Orthopedics, Inc. (2001)
- K911686: Global Total Shoulder, Uncement Humeral Hemi-Shoul, Depuy, Inc. (1991). Our reading of the summary gave K911656, FDA’s number for Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst (Pfizer Hospital Products Group, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DePuy Global Advantage Shoulder”.

## Most influential descendants
- K033516: Depuy Global Cap HA Resurfacing Shoulder Humeral Heads (2003), 135 descendants of its own
- K061862: Axiom Orthopaedics Shoulder Resurfacing System (2006), 121 descendants of its own
- K071147: Nexa Orthopedics Total Shoulder System (2007), 120 descendants of its own
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own

## Indications for use
The DePuy Global CAP Resurfacing Replacement Shoulder is intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy Global CAP Resurfacing Replacement Shoulder is indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (Le. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. CAUTION: The DePuy Global CAP Resurfacing Replacement Shoulder is intended for cementless use only.

Source page: https://510kreport.com/device/K031971
Methodology: https://510kreport.com/methodology