# K143092: Tensyn Plug

- Pathway: 510(k) (Traditional)
- Applicant: Dallen Medical, Inc.
- Decided: Feb 11, 2015 after 106 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: 14 generations back to K954385 (1996). 178 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141264: Tensyn Band, Tensyn Fracture Plates, Dallen Medical, Inc. (2014) Summary page 4.
- K131850: Tensyn Band, Dallen Medical, Inc. (2013) Summary page 4.
- K061925: Mini Tightrope Repair Kit, Model AR-8911DS, Arthrex, Inc. (2006) Summary page 4.
- K140328: CMC Mini Tightrope, Arthrex, Inc. (2014) Summary page 4.
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 4.

## Most influential descendants
- K150359: Tensyn Plug (2015), 0 descendants of its own

## Indications for use
Tensyn Plug is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn Plug apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn Plug is used in conjunction with, but not connected to, supplemental fixation. The subject device is intended 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 Tensyn Plug is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. The Tensyn Plug, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (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 metacarpal when the trapezium has been excised due to osteoarthritis.

Source page: https://510kreport.com/device/K143092
Methodology: https://510kreport.com/methodology