# K123350: Eclipse Soft Tissue Fastener

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Mar 7, 2013 after 127 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: 3 generations back to K052607 (2005). 4 ancestors in all.
2 later devices descend from it; 2 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)
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005) Summary page 1.
- K101808: Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue Fastner, Medshape Solutions (2010) Summary page 2.

## Most influential descendants
- 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, Inc., Eclipse 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, Acromnio-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, Carpomnetacarpal 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/K123350
Methodology: https://510kreport.com/methodology