# K070882: Stryker Peek Twinloop Tac

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Jul 20, 2007 after 112 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: 4 generations back to K961555 (1996). 11 ancestors in all.
35 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971723: Fastak Suture Anchor (11.7MM)/(7.5MM), Arthrex, Inc. (1997) Summary page 1.
- K000506: Bio-Fastak Suture Anchor, Model AR-1324B, Arthrex, Inc. (2000) Summary page 1.
- K050749: Arthrex Tak Family, Arthrex, Inc. (2005) Summary page 1.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 1.
- K043337: Arthrex Bio-Corkscrew FT Suture Anchor, Arthrex, Inc. (2004) Summary page 1.

## Most influential descendants
- K120509: Stryker All Suture Anchors (2012), 27 descendants of its own
- K133671: Iconix All Suture Anchors (2014), 25 descendants of its own
- K151201: Stryker ICONIX with Needles (2015), 10 descendants of its own
- K173074: ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor (2018), 5 descendants of its own
- K231078: All-Suture Anchor (2023), 3 descendants of its own

## Indications for use
The Stryker PEEK TwinLoop Tac is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, digital tendon transfers, Mid-foot reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Pelvis: Bladder Neck Suspension for Female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency. Hip: Capsular repair, acetabular labral repair. The Stryker PEEK TwinLoop Tac is intended for single-use only.

Source page: https://510kreport.com/device/K070882
Methodology: https://510kreport.com/methodology