# K112526: Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 31, 2012 after 153 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: 8 generations back to K961555 (1996). 26 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK), Smith & Nephew, Inc. (2011)
- K100159: Smith and Nephew Twinfix Ultra TI Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 1.
- K093228: Smith & Nephew Twinfix Ultra PK Suture Anchor, Smith & Nephew, Inc. (2009) Summary page 1.
- K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor, Smith & Nephew, Inc. (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
- K222763: Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (2022), 1 descendant of its own
- K202153: Responsive Arthroscopy Suture Anchor System (2020), 1 descendant of its own
- K253010: Mini Superhawk Suture Anchor System (2025), 0 descendants of its own

## Indications for use
The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs; SLAP lesion repairs; Acromnioclavicular separation repairs; Rotator cuff tear repairs; Capsular shift or capsulolabral reconstructions; Biceps tenodesis; Deltoid repairs. Foot and Ankle: Hallux valgus repairs; Medial or lateral instability repairs/reconstructions; Achilles tendon repairs/reconstructions; Midfoot reconstructions; Metatarsal ligament/tendon repairs/reconstructions. Elbow: Ulnar or radial collateral ligament reconstructions; Lateral epicondylitis repair; Biceps tendon reattachment. Knee: Extra-capsular repairs: Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament; Iliotibial band tenodesis; Patellar realignment and tendon repairs: Vastus medialis oblicjous advancement. Hip: Abductor tendon repair

Source page: https://510kreport.com/device/K112526
Methodology: https://510kreport.com/methodology