# K210159: IntraLock System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics, LLC
- Decided: Jul 23, 2021 after 183 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K000684 (2000). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182342: IntraLock Lapidus System, Fusion Orthopedics, LLC (2019) Summary page 4.
- K170038: FuzeFix Screw System, Fusion Orthopedics, LLC (2017) Summary page 4.

## Indications for use
IntraLock is indicated for reduction and internal fixation of arthrodesis, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints of the foot. The three-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform Arthrodesis.

Source page: https://510kreport.com/device/K210159
Methodology: https://510kreport.com/methodology