# K132733: Orthohelix Syndesmosis Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Jan 3, 2014 after 122 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 K954385 (1996). 101 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123203: Maxlock Extreme System Model MXL, Orthohelix Surgical Designs, Inc. (2012) Summary page 1.
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007). Our reading of the summary gave K063178, FDA’s number for Bard Collamend Implant, Models 1175102, 1175103, 1175104… (C.R. Bard, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Teleflex Force Fiber Polyethylene Non-Absorbable Surgical Suture”.
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 1.
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 1.
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 1.

## Most influential descendants
- K141264: Tensyn Band, Tensyn Fracture Plates (2014), 2 descendants of its own
- K143092: Tensyn Plug (2015), 1 descendant of its own
- K150359: Tensyn Plug (2015), 0 descendants of its own

## Indications for use
The OrthoHelix Syndesmosis Fixation Devices are indicated as adjunct fixation in repair involving metaphyseal and periarticular small bone fragments and surrounding soft-tissues 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 Syndesmosis Fixation Devices are intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of ankle syndesmosis disruptions in connection with Weber B and C ankle fractures, as well as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

Source page: https://510kreport.com/device/K132733
Methodology: https://510kreport.com/methodology