# K083792: Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055

- Pathway: 510(k) (Traditional)
- Applicant: Medshape Solutions
- Decided: Mar 25, 2009 after 96 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: 3 generations back to K990088 (1999). 11 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 16 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 1.
- K021434: Arthrex Fiberwire in Usp Sizes, Arthrex, Inc. (2002) Summary page 1.

## Most influential descendants
- K091202: Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying Diameters, (2009), 3 descendants of its own
- K141290: Helical Ridge Peek Interference Screw (2014), 0 descendants of its own
- K130467: Porous Morphix Suture Anchor with Force Fiber Suture (2013), 0 descendants of its own
- K092914: Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber Sutures (2009), 0 descendants of its own

## Indications for use
The MedShape Solutions, Inc., WedgeLoc T M Suture Anchor with Opti-FiberM Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis in the following procedures: Shoulder: Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K083792
Methodology: https://510kreport.com/methodology