# K172620: SyndesMetrics Syndesmosis Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Mortise Medical, LLC
- Decided: Nov 8, 2017 after 69 days
- Product code: HTN (Washer, Bolt Nut)
- 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: 12 generations back to K792022 (1979). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 4.
- K141219: Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits, Biomet Manufacturing Corp (2014) Summary page 4.

## Indications for use
The SyndesMetrics Syndesmosis Repair System is intended for repair in the ankle including indications for: Ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.

Source page: https://510kreport.com/device/K172620
Methodology: https://510kreport.com/methodology