# K222574: Simparo Anchor Line Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Simparo, Inc.
- Decided: Feb 4, 2023 after 163 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: 12 generations back to K792022 (1979). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140328: CMC Mini Tightrope, Arthrex, Inc. (2014) Summary page 5.
- K060970: Axyaloop Nonabsorbable Bone Anchor, Axya Medical, Inc. (2006) Summary page 5.

## Indications for use
The Simparo Anchor Line Fixation System, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as an anchor fixation system, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Simparo Anchor Line Fixation System is indicated for carpometacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis.

Source page: https://510kreport.com/device/K222574
Methodology: https://510kreport.com/methodology