# K170868: FIXIT Threaded Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: S.B.M Sas Science For Bio Materials
- Decided: Nov 30, 2017 after 252 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew, Arthrex, Inc. (2009) Summary page 4.

## Most influential descendants
- K180960: FIXIT / ComposiTCP Threaded Anchor System (2018), 1 descendant of its own
- K231787: ecoFIX® (2023), 0 descendants of its own

## Indications for use
The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction; Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ; Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; TennLs Elbow Repair and Lateral Epicondylitis Repair

Source page: https://510kreport.com/device/K170868
Methodology: https://510kreport.com/methodology