# K193614: FINE Osteotomy around the knee

- Pathway: 510(k) (Traditional)
- Applicant: Bodycad Laboratories, Inc.
- Decided: Mar 25, 2020 after 90 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: 15 generations back to K954385 (1996). 284 ancestors in all.
4 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)
- K081353: Synthes (Usa) Tomofix Medial Distal Femur Plates, Synthes (Usa) (2008) Summary page 4.
- K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 4.
- K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates, Additive Orthopaedics (2019) Summary page 4.
- K132290: Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides, Materialise NV (2014) Summary page 4.

## Most influential descendants
- K211646: FINE Osteotomy (2021), 3 descendants of its own
- 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 is a system intended for 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. Specifically, - The Fine Osteotomy tibial plates are indicated for open- and closed-wedge osteotomies of the medial proximal tibia, treatment of bone and joint deformities, fractures, non-unions, and malalignment caused by injury or disease, such as osteoarthritis, of the proximal tibia. - The Fine Osteotomy femoral plates are indicated for open- and closed wedge osteotomies of the medial and lateral distal femur, treatment of bone and joint deformities, fractures, non-unions, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur. - Fine Osteotomy instrument guides are 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/K193614
Methodology: https://510kreport.com/methodology