# K200513: DAC Dynamic Active Compression Plate

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc., Dba Rti Surgical
- Decided: Jul 22, 2020 after 142 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: 9 generations back to K954385 (1996). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws, Wrightmedicaltechnologyinc (2012) Summary page 4.

## Indications for use
The DAC plate system with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, osteotomies, arthrodeses and reconstruction of small bones of the foot such as: • Midfoot and hindfoot arthrodeses or osteotomies • Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus) • Intercuneiform arthrodeses • Naviculocuneiform arthrodeses • Talonavicular arthrodeses • Calcaneocuboid arthrodeses • Linsfranc arthrodeses • Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot • First metatarsophalangeal arthrodeses

Source page: https://510kreport.com/device/K200513
Methodology: https://510kreport.com/methodology