# K041189: Arthrex Trimit Family

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 4, 2004 after 182 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
No predicates in its family tree.
40 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K061925: Mini Tightrope Repair Kit, Model AR-8911DS (2006), 33 descendants of its own
- K071978: Mini Tightrope FT Repair Kit (2007), 22 descendants of its own
- K090107: Mini Tightrope (2009), 21 descendants of its own
- K133275: Mini Tightrope (2014), 11 descendants of its own
- K140328: CMC Mini Tightrope (2014), 6 descendants of its own

## Indications for use
The Arthrex TRIMit TM Family, made of polylactide (PLLA), are implants for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts of the foot, ankle, hand, wrist, elbow, and shoulder in the presence of appropriate brace and/or immobilization. More specific surgeries include: 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 (proximal and chevron), Midfoot Reconstruction, Metacarpal and Metatarsal fusions and Ligament Repair, Tendon transfer in the foot/ankle such as Posterior Tibial Tendon Transfer for Posterior Tibial Tendon Dysfunction, Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Dysfunction, Kidner transfer, Extensor Hallucis Longus transfer, Flexor Hallucis Longus for Achilles Tendon reconstruction, Weber A and B fractures, Lateral and Medial Malleolus Ankle Fracture, Osteochondritis Dissecans, Fractures of the Distal Radius, tibial tubercle avulsions in adolescence Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, phalangeal fracture and fusion, metacarpal fracture and fusion, carpal fusion and fracture, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures

Source page: https://510kreport.com/device/K041189
Methodology: https://510kreport.com/methodology