# K011299: Smith and Nephew 5.00MM Absorbable Polymer Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 27, 2001 after 58 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.
48 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) (2011), 40 descendants of its own
- K133671: Iconix All Suture Anchors (2014), 25 descendants of its own
- K032197: Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212 (2003), 20 descendants of its own
- K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor (2010), 16 descendants of its own
- K112526: Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors (2012), 13 descendants of its own

Source page: https://510kreport.com/device/K011299
Methodology: https://510kreport.com/methodology