510(k) · Cleared
ClearedZimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35)
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 19, 2009 as substantially equivalent to K082358 (Smith & Nephew, Inc., 2008) after a 203-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Nov 19, 2009
- Review
- 203 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082358 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK082358 Smith & Nephew, Inc. Patient Matched TechnologySmith & Nephew, Inc. · 2008
- This deviceK091263 Zimmer Patient Specific Instruments, Zimmer Patient Specific…Materialise NV · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082358 | Smith & Nephew, Inc. Patient Matched Technology | Smith & Nephew, Inc. | 2008 | — |
| 0 (this device) | K091263 | Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments… | Materialise NV | 2009 | — |
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 |
|---|---|---|---|
| * | K082358 | Smith & Nephew, Inc. Patient Matched TechnologySummary page 1…(21 CFR § 888.3560) and MBH (21 CFR § 888.3565) Predicate device Predicate Device Trade or proprietary or model name ' Patient Matched Cutting Blocks 510(k) number K082358 Decision date 11/25/2008 Product code JWH, MBH Manufacturer Smith and Nephew, Inc. Device Information Description of the devic… | 2008 |
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?
- Its one ancestor has no recall.
- 7 other devices also cite its predicate K082358.
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. 2009, 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. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments 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/K091263 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091263: Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091263
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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