# K072785: Twinfix FT PK

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Division
- Decided: Dec 10, 2007 after 70 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 K961555 (1996). 7 ancestors in all.
59 later devices descend from it; 6 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070908: Smith & Nephew Kinsa RC Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 1.
- K011219: Ascent Knee System, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) (2011), 40 descendants of its own
- K133671: Iconix All Suture Anchors (2014), 25 descendants of its own
- K093228: Smith & Nephew Twinfix Ultra PK Suture Anchor (2009), 19 descendants of its own
- K100159: Smith and Nephew Twinfix Ultra TI Suture Anchor (2010), 17 descendants of its own
- K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor (2010), 16 descendants of its own

## Indications for use
The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Bankhart Repair SLAP lesion repairs Capsular Shift or capsulolabral Reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis 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 Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis

Source page: https://510kreport.com/device/K072785
Methodology: https://510kreport.com/methodology