# K061862: Axiom Orthopaedics Shoulder Resurfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Axiom Orthopaedics, Inc.
- Decided: Aug 28, 2006 after 59 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: 6 generations back to K800494 (1980). 11 ancestors in all.
121 later devices descend from it; 1 cites it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033516: Depuy Global Cap HA Resurfacing Shoulder Humeral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K010657: Copeland MB Resurfacing Humeral Heads, Biomet Manufacturing, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K120794: Ascend Shoulder System (2012), 98 descendants of its own

## Indications for use
The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi 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 will increase shoulder mobility by reducing pain, restoring alignment, restoring flexion and extension movement, and resisting dislocation. The Axiom Orthopaedics Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by 1. Rheumatoid arthritis with pain 2. Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) 3. Correction of functional deformity 4. Fractures of the humeral head 5. Traumatic arthritis. These components are single use only and are intended for cementless use.

Source page: https://510kreport.com/device/K061862
Methodology: https://510kreport.com/methodology