510(k) · Cleared
Recalled · Class II · 2023Surgicase CMF, Surgicase Connect, Surgicase Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · JEY Plate, Bone
Cleared on Mar 18, 2011 as substantially equivalent to K093533 (Materialise NV, 2010) and 1 other predicate after a 144-day review. Its family tree reaches back 2 generations to 2008. 90 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2011
- Review
- 144 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K082358 (2008). 90 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK082358 Smith & Nephew, Inc. Patient Matched TechnologySmith & Nephew, Inc. · 2008
- 1 generation backK093533 Zimmer Patient Specific Instruments System, Version 2.0Materialise NV · 2010
- This deviceK103136 Surgicase CMF, Surgicase Connect, Surgicase GuideMaterialise NV · 2011
- Descendant · cites it directly · 59 of its ownK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- Descendant · 2 generations on · 39 of its ownK131129 Cas Psi ShoulderZimmer Cas · 2013
- Descendant · 2 generations on · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · cites it directly · 28 of its ownK120956 VSP SystemMedical Modeling, Inc. · 2012
- Descendant · 3 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 90 · See all- K112389Surgicase Connect, Surgicase GuideMaterialise NV · 2012 · cites it directly59descendants
- K131129Cas Psi ShoulderZimmer Cas · 2013 · 2 generations on39descendants
- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · 2 generations on31descendants
- K120956VSP SystemMedical Modeling, Inc. · 2012 · cites it directly28descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082358 | Smith & Nephew, Inc. Patient Matched Technology | Smith & Nephew, Inc. | 2008 | — |
| −1 | K093533 | Zimmer Patient Specific Instruments System, Version 2.0 | Materialise NV | 2010 | — |
| 0 (this device) | K103136 | Surgicase CMF, Surgicase Connect, Surgicase Guide | Materialise NV | 2011 | — |
| +1 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| +2 | K131129 | Cas Psi Shoulder | Zimmer Cas | 2013 | — |
| +2 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +1 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| +3 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 0 |
| 2023 | 10 | 0 |
| 2024 | 11 | 0 |
| 2025 | 12 | 0 |
| 2026 | 11 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 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 |
|---|---|---|---|
| * | K093533 | Zimmer Patient Specific Instruments System, Version 2.0Summary page 1…Submission information Predicate devices Trade or proprietary or model name Zimmer Patient Specific Instruments System 2.0 510(k) number K093533 Decision date 2010/02/17 Product code MBH, JWH Manufacturer… | 2010 |
| * | K082358 | Smith & Nephew, Inc. Patient Matched TechnologySummary page 1…rer Materialise N.V. Trade or proprietary or model name Smith and Nephew Patient Matched Cutting Blocks 510(k) number K082358 Decision date 2008/11/25 Product code JWH, MBH Manufacturer… | 2008 |
What descends from it? (90)
See all 903 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2023 | Class II | Z-2287-2023 | Process change control | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112389 (Materialise NV, 2012) has gone furthest, with 59 descendants of its own.
- 3 other devices also cite its predicate K093533.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
SurgiCase Guides are intended to be used as surgical tools to transfer a pre-operative plan to the surgery. The devices are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.
SurgiCase Guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K103136: Surgicase CMF, Surgicase Connect, Surgicase Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103136
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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