# K113274: Footprint Ultra PK Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 6, 2012 after 120 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: 4 generations back to K971723 (1997). 9 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 1.
- K061665: Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- K152566: PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor,  HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors (2015), 6 descendants of its own
- K180951: Responsive Arthroscopy Suture Anchor System (2019), 4 descendants of its own
- K123579: Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL (2013), 4 descendants of its own
- K173269: KATOR Suture Anchor (2018), 2 descendants of its own
- K222763: Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (2022), 1 descendant of its own

## Indications for use
The Smith & Nephew FOOTPRINT Ultra PK suture anchor family is intended for use for the reattachment 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/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux 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. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction. Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction. Hip: Distal row abductor tendon repair

Source page: https://510kreport.com/device/K113274
Methodology: https://510kreport.com/methodology