# K211843: PolyLock Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics
- Decided: Mar 4, 2022 after 262 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: 14 generations back to K954385 (1996). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202959: PolyLock Plating System, Fusion Orthopedics, LLC (2020) Summary page 4.
- K203511: Baby Gorilla/Gorilla Plating System, Paragon 28, Inc. (2020) Summary page 4.

## 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, foot, and ankle, including the distal tibia, fibula, talus, and calcaneus. 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/K211843
Methodology: https://510kreport.com/methodology