510(k) · Cleared
ClearedNewclip Patient-matched instrumentation non sterile PSI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newclip Technics · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Oct 1, 2025 as substantially equivalent to K243912 (Newclip Technics, 2025) after a 202-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Oct 1, 2025
- Review
- 202 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K924630 (1993). 14 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations between
- 3 generations backK221615 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2023
- 2 generations backK240415 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2024
- 1 generation backK243912 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025
- This deviceK250767 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025
Show all 10 generations
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 9 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 8 generations backK033849 Simplant SystemMaterialise NV · 2004
- 7 generations backK073449 SurgicaseMaterialise NV · 2008
- 6 generations backK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- 5 generations backK132290 Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV · 2014
- 4 generations backK163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV · 2017
- 3 generations backK221615 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2023
- 2 generations backK240415 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2024
- 1 generation backK243912 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025
- This deviceK250767 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −9 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −8 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −7 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −6 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| −5 | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise NV | 2014 | — |
| −4 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017 | — |
| −3 | K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023 | — |
| −2 | K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2024 | — |
| −1 | K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025 | — |
| 0 (this device) | K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PBF device
- #1 K241811 MedCAD® AccuStride™ Systemscore 17.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243912 | Newclip Patient-matched instrumentation non sterile PSISummary page 5…bone fixation appliances and accessories Classification Panel: Orthopedic Regulation: 21 CFR 888.3030 C. PREDICATE DEVICE K243912 Newclip Patient-matched instrumentation non sterile PSI… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All PBF devicesPBF Orthopaedic Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PBF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBF
227in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBF
No recall names PBF since 2007.
Adverse event reports per year · PBF
62in 2025
MAUDE reports naming product code PBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 12 |
| 2022 | 3 | 435 | 0 | 53 |
| 2023 | 5 | 314 | 0 | 45 |
| 2024 | 3 | 62 | 0 | 34 |
| 2025 | 8 | 227 | 0 | 62 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250767 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250767: Newclip Patient-matched instrumentation non sterile PSI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250767
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026