# K131670: Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 3, 2013 after 26 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: 3 generations back to K041081 (2004). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010) Summary page 1.
- K091294: Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010, Compression Fusion Plate,, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K061748: Fragment Plate System, Hand Innovations, LLC (2006) Summary page 1.

## Most influential descendants
- K182201: Stratum™ Foot Plating System (2018), 4 descendants of its own
- K212979: CalcShift™ Displacement Calcaneal Osteotomy System (2022), 0 descendants of its own
- K213301: InCore Subtalar System (2021), 0 descendants of its own
- K212640: Stratum® Ankle Fusion Plating System (2021), 0 descendants of its own
- K200785: Stratum™ Reduced Size Foot Plating System (2020), 0 descendants of its own

## Indications for use
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 -21 years of age)), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Source page: https://510kreport.com/device/K131670
Methodology: https://510kreport.com/methodology