# K240947: TENSOR®  Suture Button System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jun 3, 2024 after 56 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). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System, Arthrex, Inc. (2020) Summary page 5.
- K213644: Arthrex Knotless Mini TightRopes, Arthrex, Inc. (2021) Summary page 5.
- K173278: ToggleLoc System, Biomet, Inc. (2018) Summary page 5.

## Indications for use
The TENSOR® Suture Button System is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the TENSOR® implants are intended to provide fixation during the healing process for the following indications: Syndesmotic trauma, such as ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures; fixation of dorsal distal radioulnar ligament (DRUL) disruptions; Acromioclavicular separations due to coracoclavicular ligament disruptions; Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal-2nd metatarsal intermetatarsal angle; and, Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process.

Source page: https://510kreport.com/device/K240947
Methodology: https://510kreport.com/methodology