# K992394: Buechel-Pappas Humeral Head Resurfacing Component

- Pathway: 510(k) (Traditional)
- Applicant: Endotec, Inc.
- Decided: Oct 15, 1999 after 88 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
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023096: Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System (2003), 10 descendants of its own
- 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

## Indications for use
The BUECHEL-PAPPAS™ 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. Biocoat® porous coated components are intended for cemented use only.

Source page: https://510kreport.com/device/K992394
Methodology: https://510kreport.com/methodology