# K250394: Fine TTO™

- Pathway: 510(k) (Traditional)
- Applicant: Bodycad Laboratories, Inc.
- Decided: Oct 21, 2025 after 251 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: 3 generations back to K000682 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241356: Fine Osteotomy™, Bodycad Laboratories, Inc. (2024) Summary page 5.

## Indications for use
Fine TTO™ is a patient-specific system intended for tibial tuberosity osteotomies (TTO) in skeletally mature patients. The device is intended to assist in pre-operative planning and in guiding surgical instruments during the procedure, and should be used only when the anatomical landmarks required for planning can be clearly identified on the patient's radiographic images.

Source page: https://510kreport.com/device/K250394
Methodology: https://510kreport.com/methodology