# K101808: Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue Fastner

- Pathway: 510(k) (Traditional)
- Applicant: Medshape Solutions
- Decided: Nov 8, 2010 after 132 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 K052607 (2005). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062466: Arthrex Interference Screw, Arthrex, Inc. (2006) Summary page 2.

## Most influential descendants
- K123350: Eclipse Soft Tissue Fastener (2013), 2 descendants of its own
- K111471: Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size) (2011), 1 descendant of its own
- K141290: Helical Ridge Peek Interference Screw (2014), 0 descendants of its own
- K132783: Exoshape Duo Soft Tissue Fastener (2013), 0 descendants of its own

## Indications for use
The MedShape Solutions, Inc., ShapeLaC TM Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures: 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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers Knee: Cruciate Ligament Repair, 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, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K101808
Methodology: https://510kreport.com/methodology