# K221615: Newclip Patient-matched instrumentation non sterile PSI

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Oct 25, 2023 after 509 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: 7 generations back to K924630 (1993). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163156: SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, Materialise NV (2017) Summary page 4.

## Most influential descendants
- K240415: Newclip Patient-matched instrumentation non sterile PSI (2024), 2 descendants of its own
- K243912: Newclip Patient-matched instrumentation non sterile PSI (2025), 1 descendant of its own
- K250767: Newclip Patient-matched instrumentation non sterile PSI (2025), 0 descendants of its own

## 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 High Tibial Medial Opening Wedge Osteotomy and Distal Femoral Lateral Opening Wedge 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 High Tibial Osteotomy System or the Newclip Activmotion Range.

Source page: https://510kreport.com/device/K221615
Methodology: https://510kreport.com/methodology