# K141290: Helical Ridge Peek Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Sep 29, 2014 after 133 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: 7 generations back to K961555 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091202: Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying Diameters,, Medshape Solutions (2009) Summary page 4.
- K123350: Eclipse Soft Tissue Fastener, MedShape, Inc. (2013) Summary page 4.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 4.
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005) Summary page 4.

## Indications for use
The MedShape PEEK Interference Screw is intended for soft tissue to bone reattachment in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically; Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, llliotibial Band Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (Basal Thumb Joint Arthroplasty), Carpal Ligament Reconstructions and Repairs, Tendon Transfer in the Hand/Wrist

Source page: https://510kreport.com/device/K141290
Methodology: https://510kreport.com/methodology