510(k) · Cleared
ClearedSurgicase Connect, Surgicase Guide
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 Jul 20, 2012 as substantially equivalent to K073449 (Materialise NV, 2008) and 1 other predicate after a 337-day review. Its family tree reaches back 4 generations to 1993. 59 later devices descend from it.
- Decided
- Jul 20, 2012
- Review
- 337 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K924630 (1993). 8 ancestors in all, the oldest K924810 (1993). 59 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 2 generations backK033849 Simplant SystemMaterialise NV · 2004
- 1 generation backK073449 SurgicaseMaterialise NV · 2008
- This deviceK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- Descendant · cites it directly · 39 of its ownK131129 Cas Psi ShoulderZimmer Cas · 2013
- Descendant · cites it directly · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 2 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · 3 generations on · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- Descendant · 4 generations on · 18 of its ownK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K131129Cas Psi ShoulderZimmer Cas · 2013 · cites it directly39descendants
- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · cites it directly31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 2 generations on25descendants
- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · 3 generations on23descendants
- K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −3 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −2 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −1 | K073449 | Surgicase | Materialise NV | 2008 | — |
| 0 (this device) | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| +1 | K131129 | Cas Psi Shoulder | Zimmer Cas | 2013 | — |
| +1 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +2 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +3 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| +4 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 11 | 0 |
| 2026 | 9 | 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? (2)
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 |
|---|---|---|---|
| * | K073449 | SurgicaseSummary page 1…t options Classification Name Radiological image processing system Product code : P'&f Predicate devices Trode or proprietory or modet name SurgiCase 510(k) number K073449 Decision date 2008/04/16 Product code Wz Manufacturer Materialise N.V. Trade or proprietary or modef name SurgiCase Guide 510{… | 2008 |
| * | K103136 | Surgicase CMF, Surgicase Connect, Surgicase GuideSummary page 1…rgiCase 510(k) number K073449 Decision date 2008/04/16 Product code Wz Manufacturer Materialise N.V. Trade or proprietary or modef name SurgiCase Guide 510{k) number K103136 Decision date 2011/04/18 Product code JEY, MQN Manufacturer Materialise N.V. fe 12 Device Information Descripti… | 2011 |
What descends from it? (59)
See all 593 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 19 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K131129 (Zimmer Cas, 2013) has gone furthest, with 39 descendants of its own.
- 6 other devices also cite its predicate K073449.
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. 2012, 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.
The system is to be used for adult patients.
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/K112389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112389: Surgicase Connect, Surgicase Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112389
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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