# K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 24, 2011 after 119 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: 7 generations back to K961555 (1996). 14 ancestors in all.
40 later devices descend from it; 2 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072785: Twinfix FT PK, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 1.
- K011299: Smith and Nephew 5.00MM Absorbable Polymer Anchor, Smith & Nephew, Inc. (2001) Summary page 2.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 1.

## Most influential descendants
- K133671: Iconix All Suture Anchors (2014), 25 descendants of its own
- K112526: Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors (2012), 13 descendants of its own
- K151201: Stryker ICONIX with Needles (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
- K173074: ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor (2018), 5 descendants of its own

## Indications for use
The 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 mnedialis 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/K110545
Methodology: https://510kreport.com/methodology