# K231314: Fine Osteotomy™

- Pathway: 510(k) (Special)
- Applicant: Bodycad Laboratories, Inc.
- Decided: Jun 2, 2023 after 28 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- 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: 17 generations back to K954385 (1996). 286 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211646: FINE Osteotomy, Bodycad Laboratories, Inc. (2021) Summary page 4.

## Most influential descendants
- K240066: Fine Osteotomy™ (2024), 1 descendant of its own
- K240703: Fine Osteotomy™ (2024), 0 descendants of its own

## Indications for use
Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia. Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee. Fine Osteotomy™ is a patient-specific device.

Source page: https://510kreport.com/device/K231314
Methodology: https://510kreport.com/methodology