# K073509: Twinfix PK FP Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 4, 2008 after 82 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: 2 generations back to K971723 (1997). 3 ancestors in all.
64 later devices descend from it; 6 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051219: Pushlock, Arthrex, Inc. (2005) Summary page 2.

## Most influential descendants
- K093428: Smith & Nephew Knotless Instability Anchor (2009), 41 descendants of its own
- K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an (2012), 29 descendants of its own
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor (2010), 29 descendants of its own
- K113274: Footprint Ultra PK Suture Anchor (2012), 16 descendants of its own
- K093925: Lifenet System (2010), 8 descendants of its own

## Indications for use
The Smith & Nephew TWINFLX PK FP Suture Anchor 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, Illoiotibial 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.

Source page: https://510kreport.com/device/K073509
Methodology: https://510kreport.com/methodology