# K250767: Newclip Patient-matched instrumentation non sterile PSI

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Oct 1, 2025 after 202 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: 10 generations back to K924630 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243912: Newclip Patient-matched instrumentation non sterile PSI, Newclip Technics (2025) Summary page 5.

## Indications for use
The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in Distal Tibial Medial Opening or Closing Wedge Osteotomy, Distal Tibial Lateral Closing Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient’s radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip Activmotion S DTO Range.

Source page: https://510kreport.com/device/K250767
Methodology: https://510kreport.com/methodology