# K132783: Exoshape Duo Soft Tissue Fastener

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Dec 9, 2013 after 94 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: 8 generations back to K961555 (1996). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101808: Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue Fastner, Medshape Solutions (2010) Summary page 1.
- K111471: Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size), Medshape Solutions, Inc. (2011) Summary page 1.
- K123350: Eclipse Soft Tissue Fastener, MedShape, Inc. (2013) Summary page 1.

## Indications for use
The MedShape, Inc., ExoShape Duo 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, Acromia-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 Achilles 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 Elbow: Biceps Tendon Reattachment and 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 and Tendon Transfers

Source page: https://510kreport.com/device/K132783
Methodology: https://510kreport.com/methodology