510(k) · Cleared
ClearedMaterialise TKA Guide System
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 Nov 7, 2016 as substantially equivalent to K150928 (Materialise NV, 2015) after an 87-day review. Its family tree reaches back 8 generations to 1993. 11 later devices descend from it.
- Decided
- Nov 7, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924630 (1993). 12 ancestors in all, the oldest K924810 (1993). 11 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 6 generations backK033849 Simplant SystemMaterialise NV · 2004
- 5 generations backK073449 SurgicaseMaterialise NV · 2008
- 4 generations backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- 3 generations backK121640 Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · Recalled
- 2 generations backK133162 Zimmer Patient Specific Instruments System, Zimmer Patient Specific…Materialise NV · 2014
- 1 generation backK150928 Materialise TKA Guide System, Materialise TKA Planner, Materialise…Materialise NV · 2015
- This deviceK162273 Materialise TKA Guide SystemMaterialise NV · 2016
- Descendant · cites it directly · 9 of its ownK173445 Materialise TKA Guide SystemMaterialise NV · 2018 · Recalled
- Descendant · cites it directly · 6 of its ownK172650 Materialise PKA Guide SystemMaterialise NV · 2017
- Descendant · 2 generations on · 5 of its ownK173970 Materialise PKA Guide SystemMaterialise NV · 2018
- Descendant · 3 generations on · 3 of its ownK211512 VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K173445Materialise TKA Guide SystemMaterialise NV · 2018 · cites it directly9descendants
- K172650Materialise PKA Guide SystemMaterialise NV · 2017 · cites it directly6descendants
- K173970Materialise PKA Guide SystemMaterialise NV · 2018 · 2 generations on5descendants
- K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021 · 3 generations on3descendants
- K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −7 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −6 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −5 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −4 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| −3 | K121640 | Zimmer Patient Specific Instruments System | Materialise NV | 2012 | 1 |
| −2 | K133162 | Zimmer Patient Specific Instruments System, Zimmer Patient Specific… | Materialise NV | 2014 | — |
| −1 | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | Materialise NV | 2015 | — |
| 0 (this device) | K162273 | Materialise TKA Guide System | Materialise NV | 2016 | — |
| +1 | K173445 | Materialise TKA Guide System | Materialise NV | 2018 | 1 |
| +1 | K172650 | Materialise PKA Guide System | Materialise NV | 2017 | — |
| +2 | K173970 | Materialise PKA Guide System | Materialise NV | 2018 | — |
| +3 | K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021 | — |
| +4 | K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024 | — |
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 |
|---|---|---|
| 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 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? (1)
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 |
|---|---|---|---|
| * | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesSummary page 5…y or model name Materialise TKA Guide System Zimmer Patient Specific Instrument 510(k) number K150928 System 2.5 Decision date August 10, 2015 Classification product c… | 2015 |
What descends from it? (11)
See all 112 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 23 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K173445 (Materialise NV, 2018) has gone furthest, with 9 descendants of its own.
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. 2016, 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?
The Materialise TKA Guide 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 Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed…
Read the full statement (183 words)
The Materialise TKA Guide 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 Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, 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™ Total Knee System, AGC® Complete Knee system, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR and Omni Apex PS total knee prostheses during total knee arthroplasty surgical procedures.
The Materialise TKA 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/K162273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162273: Materialise TKA Guide System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162273
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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