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 25, 2023 as substantially equivalent to K163156 (Materialise NV, 2017) after a 509-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.
- Decided
- Oct 25, 2023
- Review
- 509 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 11 ancestors in all, the oldest K924810 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK073449 SurgicaseMaterialise NV · 2008
- 3 generations backK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- 2 generations backK132290 Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV · 2014
- 1 generation backK163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV · 2017
- This deviceK221615 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2023
- Descendant · cites it directly · 2 of its ownK240415 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2024
- Descendant · 2 generations on · 1 of its ownK243912 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025
- Descendant · 3 generations on · 0 of its ownK250767 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025
Most influential descendants
Showing 3 of 3 · See all- K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2024 · cites it directly2descendants
- K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025 · 2 generations on1descendant
- K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −3 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| −2 | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise NV | 2014 | — |
| −1 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017 | — |
| 0 (this device) | K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023 | — |
| +1 | K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2024 | — |
| +2 | K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesSummary page 4…c bone fixation appliances and accessories Classification Panel: Orthopedic Regulation: 21 CFR 888.3030 C. PREDICATE DEVICE K163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides (Materialise N.V). === Pag… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | 2024 | 2 |
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 30 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K240415 (Newclip Technics, 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K163156.
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. 2023, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221615: Newclip Patient-matched instrumentation non sterile PSI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221615
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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