# K182342: IntraLock Lapidus System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics, LLC
- Decided: May 21, 2019 after 266 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T, Quality Electrodynamics (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K090317: Babi*Plus Bubble Pap Valve, A Plus Medical (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K210159: IntraLock System (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K182342
Methodology: https://510kreport.com/methodology