# K023096: Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Std Mfg., Inc.
- Decided: Apr 10, 2003 after 204 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003044 (2000). 3 ancestors in all.
10 later devices descend from it; 3 cite 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)
- K003044: Copeland Resurfacing Heads, Biomet, Inc. (2000) Summary page 3.
- K010664: Copeland Resurfacing Humeral Heads, Biomet Manufacturing, Inc. (2001)
- K992394: Buechel-Pappas Humeral Head Resurfacing Component, Endotec, Inc. (1999) Summary page 3.

## Most influential descendants
- K131298: Exactech Equinoxe Resurfacing Humeral Head System (2013), 8 descendants of its own
- K152825: Catalyst CSR Shoulder System (2016), 7 descendants of its own
- K181287: Catalyst CSR Shoulder System (2018), 3 descendants of its own
- K182500: Catalyst CSR Press-Fit Humeral Components (2019), 2 descendants of its own
- K222317: Catalyst EA Convertible Stemmed Shoulder (2022), 1 descendant of its own

## Recalls of this device
- Nov 24, 2014 · Class II · Z-1112-2015: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- Nov 24, 2014 · Class II · Z-1114-2015: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- Nov 24, 2014 · Class II · Z-1113-2015: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- Nov 24, 2014 · Class II · Z-1111-2015: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- Nov 24, 2014 · Class II · Z-1110-2015: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.

## 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/K023096
Methodology: https://510kreport.com/methodology