# K171703: PUMA System

- Pathway: 510(k) (Traditional)
- Applicant: Panther Orthopedics, Inc.
- Decided: Mar 1, 2018 after 266 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: 10 generations back to K792022 (1979). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090107: Mini Tightrope, Arthrex, Inc. (2009) Summary page 5.
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 5.
- K142727: CrossCLIP Implant System, Orthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems (2014) Summary page 5.

## Indications for use
The PUMA System 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. The PUMA System 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 PUMA System is indicated to provide fixation during the healing process for the following: • Fixation of Syndesmosis disruptions in connection with Weber B and C ankle fractures. • Fixation of Syndesmosis disruptions in connection with dorsal distal radioulnar ligament (DRUL) disruptions. • Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc Injury. • Hallux Valgus reconstruction by providing for the reduction of 1st and 2nd metatarsal intermetatarsal angle.

Source page: https://510kreport.com/device/K171703
Methodology: https://510kreport.com/methodology