# K193122: Biocore9 Humeral Resurfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Biocore9, LLC
- Decided: May 15, 2020 after 185 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: 1 generation back to K992394 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992394: Buechel-Pappas Humeral Head Resurfacing Component, Endotec, Inc. (1999) Summary page 4.

## Indications for use
The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.

Source page: https://510kreport.com/device/K193122
Methodology: https://510kreport.com/methodology