# K233730: Footprint Mini PK, 3.5mm Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew
- Decided: Jan 17, 2024 after 57 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093428: Smith & Nephew Knotless Instability Anchor, Smith & Nephew Endoscopy, Inc. (2009) Summary page 5.
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 5.

## Indications for use
The FOOTPRINT MINI PK, 3.5mm Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle: * Medial or lateral instability repairs/reconstructions * Achilles tendon repairs/reconstructions Knee: * Extra-capsular repairs -Medial collateral ligament -Lateral collateral ligament -Posterior oblique ligament

Source page: https://510kreport.com/device/K233730
Methodology: https://510kreport.com/methodology