510(k) · Cleared
Recalled · 2012Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments
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 Oct 13, 2011 as substantially equivalent to K093533 (Materialise NV, 2010) after a 135-day review. Its family tree reaches back 2 generations to 2008. 1 of the 317 devices in its family, counting itself, has a Class I recall. 314 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 13, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082358 (2008). 314 later devices descend from it, 7 citing it directly. 1 of the 317 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK082358 Smith & Nephew, Inc. Patient Matched TechnologySmith & Nephew, Inc. · 2008
- 1 generation backK093533 Zimmer Patient Specific Instruments System, Version 2.0Materialise NV · 2010
- This deviceK111492 Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer…Materialise NV · 2011
- Descendant · cites it directly · 251 of its ownK113666 Xia 3 Spinal SystemStryker Spine · 2012
- Descendant · 2 generations on · 93 of its ownK133350 Revere Stabilization SystemGlobus Medical, Inc. · 2014
- Descendant · 2 generations on · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
- Descendant · 2 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · cites it directly · 81 of its ownK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
Showing 5 of 314 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 314 · See all- K113666Xia 3 Spinal SystemStryker Spine · 2012 · cites it directly251descendants
- K133350Revere Stabilization SystemGlobus Medical, Inc. · 2014 · 2 generations on93descendants
- K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · 2 generations on84descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 2 generations on83descendants
- K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · cites it directly81descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082358 | Smith & Nephew, Inc. Patient Matched Technology | Smith & Nephew, Inc. | 2008 | — |
| −1 | K093533 | Zimmer Patient Specific Instruments System, Version 2.0 | Materialise NV | 2010 | — |
| 0 (this device) | K111492 | Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific… | Materialise NV | 2011 | — |
| +1 | K113666 | Xia 3 Spinal System | Stryker Spine | 2012 | — |
| +2 | K133350 | Revere Stabilization System | Globus Medical, Inc. | 2014 | — |
| +2 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
| +2 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +1 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 14 | 0 |
| 2016 | 8 | 0 |
| 2017 | 18 | 0 |
| 2018 | 18 | 0 |
| 2019 | 17 | 0 |
| 2020 | 18 | 0 |
| 2021 | 21 | 1 |
| 2022 | 24 | 0 |
| 2023 | 39 | 0 |
| 2024 | 44 | 0 |
| 2025 | 38 | 0 |
| 2026 | 41 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K093533 | Zimmer Patient Specific Instruments System, Version 2.0Summary page 1…e device Predicate Device Trade or proprietary or model name Zimmer Patient Specific Instrument System 2.0 510(k) number K093533 Decision date 17/0212010 Product code JWH, MBH Manufacture… | 2010 |
What descends from it? (314)
See all 3147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113666 | Xia 3 Spinal System | 2012 | 251 |
| K130932 | Firebird Spinal Fixation System | 2013 | 81 |
| K121640 | Zimmer Patient Specific Instruments System | 2012 | 60 |
| K113829 | Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer… | 2012 | 13 |
| K131409 | Cas Psi Knee System | 2013 | 2 |
| K180220 | SAGICO OSI Spinal System by Osimplant | 2018 | 1 |
| K232561 | Ripley Spinal Screw System by SAGICO | 2023 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2012 | Not classified | Z-1543-2012 | Labeling mix-ups | March 23, 2012 a field representative reported patient specific -0242-L tibia guide case packaging contained a different patient specific -0864-R tibia guide. The two patient specific products had been switched in packaging. Neither… |
| Mar 23, 2012 | Not classified | Z-1544-2012 | Labeling mix-ups | March 23, 2012 a field representative reported patient specific --0242 L tibia guide case packaging contained a different patient specific ..-0864-R tibia guide. The two patient specific products had been switched in packaging. Neither… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113666 (Stryker Spine, 2012) has gone furthest, with 251 descendants of its own.
- 3 other devices also cite its predicate K093533.
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. 2011, 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 Zimmer Patient Specific Instruments 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 piatient imaging scans. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed…
Read the full statement (108 words)
The Zimmer Patient Specific Instruments 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 piatient imaging scans.
The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXCEN IPS-FLEX fixed bearing, Zimmer NEXGEN IPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing 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/K111492 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111492
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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