# K062861: Ascension Humeral Resurfacing Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Oct 31, 2006 after 36 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K800494 (1980). 23 ancestors in all.
2 later devices descend from it; 2 cite it directly.
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 2.
- K051843: Copeland Eas Humeral Resurfacing Heads, Biomet, Inc. (2005) Summary page 2.
- K031971: Global Cap Resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K213827: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (2022), 0 descendants of its own
- K071064: Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HA (2007), 0 descendants of its own

## Recalls of this device
- Nov 16, 2018 · Class III · Z-0794-2019: The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).

## 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. * Malunions of the humeral head. * Acute fractures of the humeral head * Patients with an intact or reparable rotator cuff.

Source page: https://510kreport.com/device/K062861
Methodology: https://510kreport.com/methodology