# K202959: PolyLock Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics, LLC
- Decided: Nov 24, 2020 after 55 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: 13 generations back to K954385 (1996). 72 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192323: PolyLock Small Bone Plating System, Fusion Orthopedics, LLC (2019) Summary page 4.
- K151235: Medline Foot Plates and Screws, Medline Industries, Inc. (2015) Summary page 4.
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K172148: Anchorage Bone Plating System, Stryker GmbH (2018) Summary page 4.

## Most influential descendants
- K211843: PolyLock Plating System (2022), 0 descendants of its own

## Indications for use
The PolyLock Plating System is indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.

Source page: https://510kreport.com/device/K202959
Methodology: https://510kreport.com/methodology