# K132510: Biopro - Infinity Plate Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Oct 24, 2013 after 73 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: 2 generations back to K914472 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013806: Synthes Metallic Spiked Washers, Synthes (Usa) (2002) Summary page 1.

## Indications for use
The BioPro - InfinityTM Plate Anchor System is indicated for ligament reattachment or fixation. The BioPro Infinity TM Plate and Screw(s) is supplied 'sterile' and intended for 'single-use' only. The system is not intended for spinal use.

Source page: https://510kreport.com/device/K132510
Methodology: https://510kreport.com/methodology