# K111471: Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)

- Pathway: 510(k) (Special)
- Applicant: Medshape Solutions, Inc.
- Decided: Jun 10, 2011 after 14 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K961555 (1996). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 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.
- K091093: Parcus Ppek CF Interference Screw, Parcus Medical, LLC (2009) Summary page 1.
- K062466: Arthrex Interference Screw, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- K132783: Exoshape Duo Soft Tissue Fastener (2013), 0 descendants of its own

## Recalls of this device
- Apr 4, 2013 · Class II · Z-1276-2013: Expiration date on the patient label and date on the product carton were not the same.

## Indications for use
The MedShape Solutions, Inc., ExoShape TM -XL Interference Fixation Device is intended for fixation of soft tissue to bone 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, Hailux 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/K111471
Methodology: https://510kreport.com/methodology