510(k) · Cleared
Recalled · Class II · 2013Signature Planner / Signature Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on May 16, 2011 as substantially equivalent to K102795 (Materialise NV, 2011) and 1 other predicate after a 91-day review. Its family tree reaches back 5 generations to 1993. 13 later devices descend from it. It has been recalled once.
- Decided
- May 16, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924630 (1993). 8 ancestors in all, the oldest K924810 (1993). 13 later devices descend from it, 4 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 backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- This deviceK110415 Signature Planner / Signature GuidesMaterialise NV · 2011
- Descendant · cites it directly · 9 of its ownK173445 Materialise TKA Guide SystemMaterialise NV · 2018 · Recalled
- Descendant · cites it directly · 7 of its ownK112301 Zimmer Patient Specific Instruments PlannerMaterialise NV · 2012
- Descendant · 2 generations on · 6 of its ownK172650 Materialise PKA Guide SystemMaterialise NV · 2017
- Descendant · cites it directly · 5 of its ownK173970 Materialise PKA Guide SystemMaterialise NV · 2018
- Descendant · 2 generations on · 3 of its ownK211512 VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K173445Materialise TKA Guide SystemMaterialise NV · 2018 · cites it directly9descendants
- K112301Zimmer Patient Specific Instruments PlannerMaterialise NV · 2012 · cites it directly7descendants
- K172650Materialise PKA Guide SystemMaterialise NV · 2017 · 2 generations on6descendants
- K173970Materialise PKA Guide SystemMaterialise NV · 2018 · cites it directly5descendants
- K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, 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 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| 0 (this device) | K110415 | Signature Planner / Signature Guides | Materialise NV | 2011 | — |
| +1 | K173445 | Materialise TKA Guide System | Materialise NV | 2018 | 1 |
| +1 | K112301 | Zimmer Patient Specific Instruments Planner | Materialise NV | 2012 | — |
| +2 | K172650 | Materialise PKA Guide System | Materialise NV | 2017 | — |
| +1 | K173970 | Materialise PKA Guide System | Materialise NV | 2018 | — |
| +2 | K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 HRY? 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 HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K102795 | Signature Planner; Signature GuidesSummary page 1…devices Predicate Device Trade or proprietary or model name Signaturem Personalized Patient Care System 510(k) number K(102795 Decision date 02/02/2011 Product code JWH/OIY, MBH, OOG Ma… | 2011 |
| * | K082358 | Smith & Nephew, Inc. Patient Matched TechnologySummary page 1…Materialise N.V. Predicate Device Trade or proprietary or model name Patient Matched Cutting Blocks 510(k) number K082358 Decision date 11/25/2008 Product code JWH, MW-I Manufactur… | 2008 |
What descends from it? (13)
See all 134 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 |
|---|---|---|---|---|
| Nov 26, 2013 | Class II | Z-0628-2014 | Nonconforming Material/Component | Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. |
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 3.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K173445 (Materialise NV, 2018) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K102795.
How does its category compare?
All HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 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 · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, 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 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Signaturet " Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Signaturet " Personalized Patient Care System can be used…
Read the full statement (132 words)
Signaturet " Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signaturet " Personalized Patient Care System can be used with the following Biomete Knee Systems and their respective components: Vanguard TM Complete Knee System, Vanguard T" M Unicompartmental Knee System, Vanguard"TI SK 360, Vanguard T" SSK Revision Knee System, Regenerext " Primary Tibial System, Offset & Microplasty Tibial Systems, Maxi mT" Complete Knee System, Ascent'" Total Knee System, and AGC'" Complete Knee system.
The Signature'" guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110415: 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/K110415
Report an extraction error
Are you the manufacturer?
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