# K113294: Smith & Nephew Healicoil PK Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 20, 2012 after 73 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
No predicates in its family tree.
23 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K105454: Smith & Nephew Next Generation Fully Threaded PK Suture Anchor. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K143745: Arthrex Corkscrew and SwiveLock Suture Anchors (2015), 10 descendants of its own
- 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
- K123393: Healicoil Suture Anchor with Regenesorb (2013), 4 descendants of its own
- K202763: Fix2Lock (PEEK Self Punching) (2021), 2 descendants of its own

## Indications for use
The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Iliotibial band tenodesis. Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Hip: Gluteal tendon repairs Gluteus medius and gluteus minimus repair

Source page: https://510kreport.com/device/K113294
Methodology: https://510kreport.com/methodology