# K142942: HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System

- Pathway: 510(k) (Special)
- Applicant: Arthrosurface, Inc.
- Decided: Dec 19, 2014 after 66 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). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023096: Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System, Std Mfg., Inc. (2003) Summary page 5.
- K003044: Copeland Resurfacing Heads, Biomet, Inc. (2000) Summary page 5.
- K010664: Copeland Resurfacing Humeral Heads, Biomet Manufacturing, Inc. (2001) Summary page 5.
- K031971: Global Cap Resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc. (2003) Summary page 5.

## Most influential descendants
- K173964: OVOMotion Shoulder Arthroplasty System (2018), 0 descendants of its own

## Indications for use
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

Source page: https://510kreport.com/device/K142942
Methodology: https://510kreport.com/methodology