# K192323: PolyLock Small Bone Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics, LLC
- Decided: Nov 18, 2019 after 83 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) N.O. Modular Foot-Osteosynthesis System: named in the summary without a submission number
- (no number) Medline Mini Foot Plating System: named in the summary without a submission number
- (no number) Medline Foot Recon Plating System: named in the summary without a submission number
- (no number) Wright Medical PRO? Small Bone Plating System: named in the summary without a submission number
- (no number) Wright Medical MaxLock Extreme: named in the summary without a submission number
- (no number) DePuy Synthes LCP ForeFoot/MidFoot: named in the summary without a submission number
- (no number) DePuy Synthes Locking Foot Module: named in the summary without a submission number

## Most influential descendants
- K202959: PolyLock Plating System (2020), 1 descendant of its own
- K211843: PolyLock Plating System (2022), 0 descendants of its own

## Indications for use
The PolyLock 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, calcanco-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/K192323
Methodology: https://510kreport.com/methodology