510(k) · Cleared
ClearedSignature Planner,Signature Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jun 15, 2012 as substantially equivalent to K073449 (Materialise NV, 2008) and 2 other predicates after a 351-day review. Its family tree reaches back 7 generations to 1991. 71 later devices descend from it.
- Decided
- Jun 15, 2012
- Review
- 351 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K905070 (1991). 24 ancestors in all, the oldest K861692 (1986). 71 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 6 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 5 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 4 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 3 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 2 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 1 generation backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- This deviceK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- Descendant · cites it directly · 38 of its ownK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- Descendant · cites it directly · 35 of its ownK131559 Match Point System (TM), Surgicase Connect, Match Point System (TM)…Materialise NV · 2013
- Descendant · 2 generations on · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 3 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · 4 generations on · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013 · cites it directly38descendants
- K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV · 2013 · cites it directly35descendants
- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · 2 generations on31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 3 generations on25descendants
- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −6 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −5 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −4 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −3 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −2 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −1 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| 0 (this device) | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| +1 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| +1 | K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | Materialise NV | 2013 | — |
| +2 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +3 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +4 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 11 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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…WZ, JDl, KWY, MAY, M EH Predicate devices Predicate Device Trade or proprietary or model name SurgiCase 510(k) number K073449 Decision date 04/16/2008 Product code LLZ Manufacturer… | 2008 |
| * | K102795 | Signature Planner; Signature GuidesSummary page 2…Materialise N.V. Predicate Device Trade or proprietary or model name Signature TM Personalized Patient Care System 510(k) number K102795 Decision date 02/02/2011 Product code JWH/OIY, MBH, 0CC Manufacturer… | 2011 |
| * | K031454 | Acumen Surgical Navigation SystemSummary page 2…er Materialise N.V. Predicate Device Trade or proprietary or model name Acumen Surgical Navigation System 510(k) number K031454 Decision date 07/08/2004 Product code HAW Manufacturer Bio… | 2004 |
| * | — | Instrument Named without a submission number |
What descends from it? (71)
See all 715 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130126 | Signature Personalized Patient Care System - Glenoid Guide System | 2013 | 38 |
| K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | 2013 | 35 |
| K162719 | iTotal® Hip Replacement System | 2017 | 17 |
| K152893 | Corin Optimized Positioning System (OPS) | 2016 | 8 |
| K150780 | Acetabular Cup Orientation System | 2015 | 0 |
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 4 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K130126 (Biomet, Inc., 2013) has gone furthest, with 38 descendants of its own.
- 6 other devices also cite its predicate K073449.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Signature TM Personalized Patient Care System - Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans.
The SignatureT M Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components.
The Signature"4 guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111863: Signature Planner,Signature Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111863
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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