510(k) · Cleared
ClearedSurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Jan 18, 2017 as substantially equivalent to K132290 (Materialise NV, 2014) after a 69-day review. Its family tree reaches back 6 generations to 1993. 8 later devices descend from it.
- Decided
- Jan 18, 2017
- Review
- 69 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 10 ancestors in all, the oldest K924810 (1993). 8 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK073449 SurgicaseMaterialise NV · 2008
- 2 generations backK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- 1 generation backK132290 Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV · 2014
- This deviceK163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV · 2017
- Descendant · cites it directly · 3 of its ownK221615 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2023
- Descendant · cites it directly · 3 of its ownK220717 RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK241811 MedCAD® AccuStride™ SystemMedcad · 2025
- 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2023 · cites it directly3descendants
- K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022 · cites it directly3descendants
- K241811MedCAD® AccuStride™ SystemMedcad · 2025 · 2 generations on2descendants
- K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2024 · cites it directly2descendants
- K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −2 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| −1 | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise NV | 2014 | — |
| 0 (this device) | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017 | — |
| +1 | K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023 | — |
| +1 | K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022 | — |
| +2 | K241811 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
| +1 | K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2024 | — |
| +2 | K243912 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesSummary page 4…PBF Predicate devices Trade or proprietary or model name SurgiCase Orthopaedics system 510(k) number K132290 Decision date 04/10/2014 Product code PBF Manufacturer… | 2014 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K221615 (Newclip Technics, 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K132290.
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. 2017, 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 SurgiCase Orthopaedics system is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies
* For adult patients; in upper extremity orthopedic surgical procedures and orthopedic surgical procedures around the knee.
* For pediatric patients 7 years of age and older; in orthopedic surgical procedures involving the radius and ulna.
SurgiCase Guides are intended for single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163156 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163156: SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163156
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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