# K033516: Depuy Global Cap HA Resurfacing Shoulder Humeral Heads

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 3, 2003 after 26 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: 5 generations back to K800494 (1980). 9 ancestors in all.
135 later devices descend from it; 4 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031971: Global Cap Resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K113413: Ascend Shoulder System (2012), 105 descendants of its own

## Indications for use
The DePuy Global CAPTM HA Resurfacing Shoulder Humeral Heads are 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 CAPTM HA Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. CAUTION: The DePuy Global CAP T I HA Resurfacing Shoulder Humeral Heads are intended for cementless use only.

Source page: https://510kreport.com/device/K033516
Methodology: https://510kreport.com/methodology