510(k) · Cleared
ClearedSurgicase Orthopaedics System, 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 Apr 10, 2014 as substantially equivalent to K112389 (Materialise NV, 2012) after a 261-day review. Its family tree reaches back 5 generations to 1993. 18 later devices descend from it.
- Decided
- Apr 10, 2014
- Review
- 261 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924630 (1993). 9 ancestors in all, the oldest K924810 (1993). 18 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK073449 SurgicaseMaterialise NV · 2008
- 1 generation backK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- This deviceK132290 Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV · 2014
- Descendant · cites it directly · 8 of its ownK163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV · 2017
- Descendant · cites it directly · 4 of its ownK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK221615 Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2023
- Descendant · 2 generations on · 3 of its ownK220717 RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022
- Descendant · 2 generations on · 3 of its ownK211646 FINE OsteotomyBodycad Laboratories, Inc. · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV · 2017 · cites it directly8descendants
- K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020 · cites it directly4descendants
- K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics · 2023 · 2 generations on3descendants
- K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022 · 2 generations on3descendants
- K211646FINE OsteotomyBodycad Laboratories, Inc. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −1 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| 0 (this device) | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise NV | 2014 | — |
| +1 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017 | — |
| +1 | K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 | — |
| +2 | K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023 | — |
| +2 | K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022 | — |
| +2 | K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 | — |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K112389 | Surgicase Connect, Surgicase GuideSummary page 1…PBF Predicate devices Trade or proprietary or model name SurgiCase Orthopaedlics system 510(k) number K112389 Decision date 07/20/2012 Product code PBF Manufact… | 2012 |
What descends from it? (18)
See all 183 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 21 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K163156 (Materialise NV, 2017) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K112389.
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. 2014, 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 upper extremity orthopedic surgical procedures and osteotomies around the knee.
The system is to be used for adult patients.
SurgiCase Guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132290: Surgicase Orthopaedics System, 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/K132290
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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