510(k) · Cleared
Recalled · Class II · 2023Materialise 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 Jul 5, 2022 as substantially equivalent to K173445 (Materialise NV, 2018) after a 57-day review. Its family tree reaches back 10 generations to 1993. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 5, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K924630 (1993). 17 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations between
- 3 generations backK150928 Materialise TKA Guide System, Materialise TKA Planner, Materialise…Materialise NV · 2015
- 2 generations backK162273 Materialise TKA Guide SystemMaterialise NV · 2016
- 1 generation backK173445 Materialise TKA Guide SystemMaterialise NV · 2018 · Recalled
- This deviceK221337 Materialise TKA Guide SystemMaterialise NV · 2022
- Descendant · cites it directly · 1 of its ownK251554 Materialise TKA Guide SystemMaterialise NV · 2025
- Descendant · 2 generations on · 0 of its ownK253793 Materialise TKA Guide SystemMaterialise NV · 2026
Show all 10 generations
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 9 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 8 generations backK033849 Simplant SystemMaterialise NV · 2004
- 7 generations backK073449 SurgicaseMaterialise NV · 2008
- 6 generations backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- 5 generations backK121640 Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · Recalled
- 4 generations backK133162 Zimmer Patient Specific Instruments System, Zimmer Patient Specific…Materialise NV · 2014
- 3 generations backK150928 Materialise TKA Guide System, Materialise TKA Planner, Materialise…Materialise NV · 2015
- 2 generations backK162273 Materialise TKA Guide SystemMaterialise NV · 2016
- 1 generation backK173445 Materialise TKA Guide SystemMaterialise NV · 2018 · Recalled
- This deviceK221337 Materialise TKA Guide SystemMaterialise NV · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −9 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −8 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −7 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −6 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| −5 | K121640 | Zimmer Patient Specific Instruments System | Materialise NV | 2012 | 1 |
| −4 | K133162 | Zimmer Patient Specific Instruments System, Zimmer Patient Specific… | Materialise NV | 2014 | — |
| −3 | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | Materialise NV | 2015 | — |
| −2 | K162273 | Materialise TKA Guide System | Materialise NV | 2016 | — |
| −1 | K173445 | Materialise TKA Guide System | Materialise NV | 2018 | 1 |
| 0 (this device) | K221337 | Materialise TKA Guide System | Materialise NV | 2022 | — |
| +1 | K251554 | Materialise TKA Guide System | Materialise NV | 2025 | — |
| +2 | K253793 | Materialise TKA Guide System | Materialise NV | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251554 | Materialise TKA Guide System | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2023 | Class II | Z-2213-2023 | Process control | The wrong tibia guide was included intended for a different patient case. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K251554 (Materialise NV, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K173445.
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. 2022, 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?
Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components. Hardware * Pin Placement Guides The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting. The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen®…
Read the full statement (526 words)
Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.
Hardware
* Pin Placement Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.
The Materialise TKA Guides must be used in conjunction with the 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.
The Materialise TKA Guides are intended for single use only.
* Cut-Through Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone.
The Materialise TKA Guides must be used in conjunction with the 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 and AGC® Complete Knee system prostheses families only
The Materialise TKA Guides are intended for single use only.
* Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components.
The Materialise TKA Models must be used in conjunction 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.
The Materialise TKA Models are intended for single use only.
Software
The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.
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/K221337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221337: Materialise TKA Guide System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221337
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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