# K123579: Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 23, 2013 after 65 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: 5 generations back to K971723 (1997). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113274: Footprint Ultra PK Suture Anchor, Smith & Nephew, Inc. (2012) Summary page 1.
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 1.

## Most influential descendants
- K173269: KATOR Suture Anchor (2018), 2 descendants of its own
- K242477: Shoulder Soft Tissue Anchors (2025), 0 descendants of its own
- K182736: OIC Suture Anchor System (2018), 0 descendants of its own
- K171964: LigaMetrics Suture Anchors (2017), 0 descendants of its own

## Indications for use
The Smith & Nephew, Inc. FOOTPRINT Ultra PK< Suture Anchor, SL is intended for use in the fixation of soft tissue to bone for the following indications: Shoulder Rotator Cuff repair, Bankart repair, Slap lesion repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or capsulolabral reconstruction Foot and Ankle Lateral stabilization, Medial stabilization, Achilles tendon repair, H-allux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair Knee Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis

Source page: https://510kreport.com/device/K123579
Methodology: https://510kreport.com/methodology