510(k) · Cleared
ClearedMaterialise PKA Guide System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Oct 2, 2020 as substantially equivalent to K173970 (Materialise NV, 2018) after a 57-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Oct 2, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K924630 (1993). 23 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 11 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations between
- 3 generations backK162273 Materialise TKA Guide SystemMaterialise NV · 2016
- 2 generations backK172650 Materialise PKA Guide SystemMaterialise NV · 2017
- 1 generation backK173970 Materialise PKA Guide SystemMaterialise NV · 2018
- This deviceK202207 Materialise PKA Guide SystemMaterialise NV · 2020
Show all 11 generations
- Root · 11 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 10 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 9 generations backK033849 Simplant SystemMaterialise NV · 2004
- 8 generations backK073449 SurgicaseMaterialise NV · 2008
- 7 generations backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- 6 generations backK121640 Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · Recalled
- 5 generations backK133162 Zimmer Patient Specific Instruments System, Zimmer Patient Specific…Materialise NV · 2014
- 4 generations backK150928 Materialise TKA Guide System, Materialise TKA Planner, Materialise…Materialise NV · 2015
- 3 generations backK162273 Materialise TKA Guide SystemMaterialise NV · 2016
- 2 generations backK172650 Materialise PKA Guide SystemMaterialise NV · 2017
- 1 generation backK173970 Materialise PKA Guide SystemMaterialise NV · 2018
- This deviceK202207 Materialise PKA Guide SystemMaterialise NV · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −10 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −9 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −8 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −7 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| −6 | K121640 | Zimmer Patient Specific Instruments System | Materialise NV | 2012 | 1 |
| −5 | K133162 | Zimmer Patient Specific Instruments System, Zimmer Patient Specific… | Materialise NV | 2014 | — |
| −4 | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | Materialise NV | 2015 | — |
| −3 | K162273 | Materialise TKA Guide System | Materialise NV | 2016 | — |
| −2 | K172650 | Materialise PKA Guide System | Materialise NV | 2017 | — |
| −1 | K173970 | Materialise PKA Guide System | Materialise NV | 2018 | — |
| 0 (this device) | K202207 | Materialise PKA Guide System | Materialise NV | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 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? (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 |
|---|---|---|---|
| * | K173970 | Materialise PKA Guide SystemSummary page 6…nce is claimed: Trade or proprietary or model name Materialise PKA Guide System 510(k) number K173970 Decision date July 6, 2018 Classification product code… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K173970.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Hardware • Guides The Materialise PKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Partial Knee Replacement components and in guiding the marking of bone before cutting and to guide cutting of the bone. The Materialise PKA Guides must be used in conjunction with the compatible prostheses families only: ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M…
Read the full statement (289 words)
Hardware
• Guides
The Materialise PKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Partial Knee Replacement components and in guiding the marking of bone before cutting and to guide cutting of the bone.
The Materialise PKA Guides must be used in conjunction with the compatible prostheses families only: ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M Unicompartmental Knee System, Oxford® Partial Knee System and Persona® Partial Knee System.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA Guides are intended for single use only.
• Models
The Materialise PKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Partial Knee Replacement components.
The Materialise PKA Models must be used in conjunction with the compatible prostheses families only: ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M Unicompartmental Knee System, Oxford® Partial Knee System and Persona® Partial Knee System.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA 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 as stated in the FDA summary.
https://510kreport.com/device/K202207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202207: Materialise PKA 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/K202207
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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