# K131834: Wolf Long Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Toby Orthopaedics
- Decided: Nov 4, 2013 after 137 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 4 generations back to K981372 (1998). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 1.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 1.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011) Summary page 1.

## Indications for use
The WOLF® Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses.

Source page: https://510kreport.com/device/K131834
Methodology: https://510kreport.com/methodology