# K071064: Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HA

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Jun 22, 2007 after 67 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: 7 generations back to K800494 (1980). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010664: Copeland Resurfacing Humeral Heads, Biomet Manufacturing, Inc. (2001) Summary page 1.
- K010827: Copeland MB/HA Resurfacing Humeral Heads, Biomet Orthopedics, Inc. (2001) Summary page 1.
- K051843: Copeland Eas Humeral Resurfacing Heads, Biomet, Inc. (2005) Summary page 1.
- K031971: Global Cap Resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K033516: Depuy Global Cap HA Resurfacing Shoulder Humeral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K062861: Ascension Humeral Resurfacing Arthroplasty System, Ascension Orthopedics, Inc. (2006) Summary page 1.

## Indications for use
The Ascension® HRA® device is intended for resurfacing of the humeral head due to: Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis). Mild or moderate humeral head deformity and / or limited motion. Post-traumatic arthritis. Patients with an intact or reparable rotator cuff.

Source page: https://510kreport.com/device/K071064
Methodology: https://510kreport.com/methodology