# K991009: RC Buttress

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 23, 1999 after 89 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K024185: Biodhoc (2004), 0 descendants of its own

## Indications for use
The RC Buttress is intended for use to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder.

Source page: https://510kreport.com/device/K991009
Methodology: https://510kreport.com/methodology