# K211646: FINE Osteotomy

- Pathway: 510(k) (Traditional)
- Applicant: Bodycad Laboratories, Inc.
- Decided: Jul 28, 2021 after 61 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: 16 generations back to K954385 (1996). 285 ancestors in all.
3 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)
- K193614: FINE Osteotomy around the knee, Bodycad Laboratories, Inc. (2020) Summary page 4.

## Most influential descendants
- K231314: Fine Osteotomy™ (2023), 2 descendants of its own
- K240066: Fine Osteotomy™ (2024), 1 descendant of its own
- K240703: Fine Osteotomy™ (2024), 0 descendants of its own

## Indications for use
Fine Osteotomy M 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/K211646
Methodology: https://510kreport.com/methodology