510(k) · Cleared
ClearedZimmer Patient Specific Instruments System, Version 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Feb 17, 2010 as substantially equivalent to K082358 (Smith & Nephew, Inc., 2008) after a 93-day review. Its family tree reaches back 1 generation to 2008. 1 of the 406 devices in its family, counting itself, has a Class I recall. 404 later devices descend from it.
- Decided
- Feb 17, 2010
- Review
- 93 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082358 (2008). 404 later devices descend from it, 4 citing it directly. 1 of the 406 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK082358 Smith & Nephew, Inc. Patient Matched TechnologySmith & Nephew, Inc. · 2008
- This deviceK093533 Zimmer Patient Specific Instruments System, Version 2.0Materialise NV · 2010
- Descendant · cites it directly · 314 of its ownK111492 Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer…Materialise NV · 2011 · Recalled
- Descendant · 2 generations on · 251 of its ownK113666 Xia 3 Spinal SystemStryker Spine · 2012
- Descendant · cites it directly · 99 of its ownK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- Descendant · 3 generations on · 93 of its ownK133350 Revere Stabilization SystemGlobus Medical, Inc. · 2014
- Descendant · cites it directly · 90 of its ownK103136 Surgicase CMF, Surgicase Connect, Surgicase GuideMaterialise NV · 2011 · Recalled
Showing 5 of 404 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 404 · See all- K111492Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsMaterialise NV · 2011 · cites it directly314descendants
- K113666Xia 3 Spinal SystemStryker Spine · 2012 · 2 generations on251descendants
- K102795Signature Planner; Signature GuidesMaterialise NV · 2011 · cites it directly99descendants
- K133350Revere Stabilization SystemGlobus Medical, Inc. · 2014 · 3 generations on93descendants
- K103136Surgicase CMF, Surgicase Connect, Surgicase GuideMaterialise NV · 2011 · cites it directly90descendants
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) | K093533 | Zimmer Patient Specific Instruments System, Version 2.0 | Materialise NV | 2010 | — |
| +1 | K111492 | Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific… | Materialise NV | 2011 | 2 |
| +2 | K113666 | Xia 3 Spinal System | Stryker Spine | 2012 | — |
| +1 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| +3 | K133350 | Revere Stabilization System | Globus Medical, Inc. | 2014 | — |
| +1 | K103136 | Surgicase CMF, Surgicase Connect, Surgicase Guide | Materialise NV | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 8 | 0 |
| 2014 | 9 | 0 |
| 2015 | 15 | 0 |
| 2016 | 11 | 0 |
| 2017 | 23 | 0 |
| 2018 | 20 | 0 |
| 2019 | 22 | 0 |
| 2020 | 31 | 0 |
| 2021 | 26 | 1 |
| 2022 | 34 | 0 |
| 2023 | 52 | 0 |
| 2024 | 50 | 0 |
| 2025 | 45 | 0 |
| 2026 | 46 | 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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…nd MBH (21 CFR § 888.=356=5)= Predicate device Predicate Device Trade or proprietary ornmodel name Patient Matched Cutting Blocks 510(k) number K082358 Decision date 11/25/2008 Product code JWH, MBH Manufacturer… | 2008 |
What descends from it? (404)
See all 4044 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 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, Zimmer NEXGEN LPS-FLEX 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/K093533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093533: Zimmer Patient Specific Instruments System, Version 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093533
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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