510(k) · Cleared
Recalled · Class II · 2016Signature Planner; Signature Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 2, 2011 as substantially equivalent to K073449 (Materialise NV, 2008) and 1 other predicate after a 128-day review. Its family tree reaches back 4 generations to 1993. 99 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 2, 2011
- Review
- 128 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 4 generations to K924630 (1993). 7 ancestors in all, the oldest K924810 (1993). 99 later devices descend from it, 7 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 deviceK102795 Signature Planner; Signature GuidesMaterialise NV · 2011
- Descendant · cites it directly · 71 of its ownK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- Descendant · cites it directly · 60 of its ownK121640 Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · Recalled
- Descendant · 2 generations on · 39 of its ownK131129 Cas Psi ShoulderZimmer Cas · 2013
- Descendant · 2 generations on · 38 of its ownK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- Descendant · 2 generations on · 35 of its ownK131559 Match Point System (TM), Surgicase Connect, Match Point System (TM)…Materialise NV · 2013
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K111863Signature Planner,Signature GuidesMaterialise NV · 2012 · cites it directly71descendants
- K121640Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · cites it directly60descendants
- K131129Cas Psi ShoulderZimmer Cas · 2013 · 2 generations on39descendants
- K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013 · 2 generations on38descendants
- K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV · 2013 · 2 generations on35descendants
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) | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | — |
| +1 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| +1 | K121640 | Zimmer Patient Specific Instruments System | Materialise NV | 2012 | 1 |
| +2 | K131129 | Cas Psi Shoulder | Zimmer Cas | 2013 | — |
| +2 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| +2 | K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | Materialise NV | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 7 | 0 |
| 2022 | 7 | 0 |
| 2023 | 12 | 0 |
| 2024 | 8 | 0 |
| 2025 | 11 | 0 |
| 2026 | 7 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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…____§ 888.3565), OOG 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 |
| * | K093533 | Zimmer Patient Specific Instruments System, Version 2.0Summary page 2…or proprietary or model name Zimmer Patient Specific Instruments _____________________________ System 2.0 510(k) number K093533 Decision date 02/17/2010 Product code .JWH, MBH Manufacturer… | 2010 |
What descends from it? (99)
See all 997 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111863 | Signature Planner,Signature Guides | 2012 | 71 |
| K121640 | Zimmer Patient Specific Instruments System | 2012 | 60 |
| K113829 | Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer… | 2012 | 13 |
| K110415 | Signature Planner / Signature Guides | 2011 | 13 |
| K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | 2015 | 12 |
| K190904 | Conformis BeneFIT Hip System | 2019 | 6 |
| K140257 | Signature Planner, Signature Guides | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2016 | Class II | Z-1941-2016 | Process control | A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient… |
| Sep 23, 2015 | Class II | Z-0162-2016 | Use error | Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed. |
| Feb 4, 2015 | Class II | Z-1287-2015 | Employee error | Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation. |
| Aug 4, 2011 | Not classified | Z-1145-2012 | Labeling mix-ups | Biomet has initiated this action following investigation that identified two (2) specific lots of part number 42-422561 were incorrectly labeled. One (1) unit (lot 025640) was received back from distributor's office as a product complaint. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K111863 (Materialise NV, 2012) has gone furthest, with 71 descendants of its own.
- 6 other devices also cite its predicate K073449.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Signature m Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The SignatureTM Personalized Patient Care System can be used with the following Biomet knee systems…
Read the full statement (116 words)
Signature m Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The SignatureTM Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard' Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent TM Total Knee System, and AGC® Complete Knee system.
The SignatureTM guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102795 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102795: Signature Planner; Signature Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102795
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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