# K123425: Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SL

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 20, 2013 after 105 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: 3 generations back to K961555 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.
- K972326: Peba Anchor/Suture Combination, Orthopaedic Biosystems, Ltd. (1998) Summary page 1.

## Indications for use
Smith &Nephew TWINFIX* Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications. Shoulder Bankari lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs Foot and Ankle Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions Elbow. Wrist and Hand Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment Knee Extra-capsular repairs: Medial collateral ligament repair, Lateral collateral ligament repair, Posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement

Source page: https://510kreport.com/device/K123425
Methodology: https://510kreport.com/methodology