510(k) · Cleared
ClearedZimmer Patient Specific Instruments Planner
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 Jan 6, 2012 as substantially equivalent to K033363 (Zimmer, Inc., 2004) and 2 other predicates after a 149-day review. Its family tree reaches back 6 generations to 1993. 7 later devices descend from it.
- Decided
- Jan 6, 2012
- Review
- 149 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K924630 (1993). 12 ancestors in all, the oldest K880155 (1988). 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK073449 SurgicaseMaterialise NV · 2008
- 2 generations backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- 1 generation backK110415 Signature Planner / Signature GuidesMaterialise NV · 2011 · Recalled
- This deviceK112301 Zimmer Patient Specific Instruments PlannerMaterialise NV · 2012
- 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
- Descendant · 5 generations on · 1 of its ownK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −2 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| −1 | K110415 | Signature Planner / Signature Guides | Materialise NV | 2011 | 1 |
| 0 (this device) | K112301 | Zimmer Patient Specific Instruments Planner | Materialise NV | 2012 | — |
| +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 | — |
| +5 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 1…3520) Predicate devices Predicate Device Trade or proprietary or model name Zimmer Unicompartmental Knee System 510(k) number K033363 Decision date 01/16/2004 Product code HSX Manufacturer… | 2004 |
| * | K110415 | Signature Planner / Signature GuidesSummary page 2…e or proprietary or model name Signature' Personalized Patient Care System 510(k) Premarket Notification 510(k) number K110415 Decision dote 05/16/2011 Product code HRY, JWH/OIY, MBH, COG Manufacturer… | 2011 |
| * | K093533 | Zimmer Patient Specific Instruments System, Version 2.0Summary page 2…Materialise N.V. Predicate Device Trade or proprietary or model name Zimmer Patient Specific Instrument System 2.0 510(k) number K093533 Decision date 02/17/2010 Product code JWH, MBH Manufacturer… | 2010 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172650 | Materialise PKA Guide System | 2017 | 6 |
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 19 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K172650 (Materialise NV, 2017) has gone furthest, with 6 descendants of its own.
- 21 other devices also cite its predicate K033363.
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. 2012, 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?
The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Zimmer Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112301: Zimmer Patient Specific Instruments Planner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112301
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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