# K213958: Bioabsorbable Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Embody, Inc.
- Decided: Apr 8, 2022 after 112 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
Longest line of descent: 8 generations back to K961555 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131635: Rotation Medical Bone Staple (RMB Staple), Rotation Medical, Inc. (2013) Summary page 4.

## Indications for use
The Bioabsorbable Anchor is indicated for the fixation of soft tissue grafts in various minimally invasive and open orthopedic surgical procedures in shoulder.

Source page: https://510kreport.com/device/K213958
Methodology: https://510kreport.com/methodology