510(k) · Cleared
ClearedConsensus Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consensus Orthopedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jun 27, 2011 as substantially equivalent to K073286 (Zimmer, Inc., 2008) and 1 other predicate after an 84-day review. Its family tree reaches back 5 generations to 1995. 14 later devices descend from it.
- Decided
- Jun 27, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933785 (1995). 12 ancestors in all. 14 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 4 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 3 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 2 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 1 generation backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- This deviceK110950 Consensus Knee SystemConsensus Orthopedics, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK163167 CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK143725 Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014 · cites it directly7descendants
- K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017 · cites it directly3descendants
- K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015 · cites it directly3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · cites it directly2descendants
- K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −4 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −3 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −2 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −1 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| 0 (this device) | K110950 | Consensus Knee System | Consensus Orthopedics, Inc. | 2011 | — |
| +1 | K133919 | Consensus Vitalite Tibial Insert | Consensus Orthopedics, Inc. | 2014 | — |
| +1 | K163167 | CKS Plus Knee System | Consensus Orthopedics, Inc. | 2017 | — |
| +1 | K143725 | Consensus Knee System Modular Tibial Baseplate | Consensus Orthopedics, Inc. | 2015 | — |
| +1 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| +1 | K160515 | PS2 Knee System | Consensus Orthopedics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 MBH? 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? (2)
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 |
|---|---|---|---|
| * | K073286 | Gender Solutions Natural-Knee Flex SystemSummary page 2…m The CKS implants are also substantially equivalent to the Gender Solutions' Natural Knee® Flex System by Zimmer, Inc. cleared in K073286 & K070214 with the above options.… | 2008 |
| * | K070214 | Gender Solutions Natural-Knee Flex SystemSummary page 2…m The CKS implants are also substantially equivalent to the Gender Solutions' Natural Knee® Flex System by Zimmer, Inc. cleared in K073286 & K070214 with the above options.… | 2007 |
What descends from it? (14)
See all 148 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133919 | Consensus Vitalite Tibial Insert | 2014 | 7 |
| K163167 | CKS Plus Knee System | 2017 | 3 |
| K143725 | Consensus Knee System Modular Tibial Baseplate | 2015 | 3 |
| K191765 | OMNI TiN Coated Apex Knee™ System | 2019 | 2 |
| K160515 | PS2 Knee System | 2016 | 2 |
| K241180 | Consensus Knee System with TiNbN | 2025 | 1 |
| K112285 | Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated… | 2011 | 1 |
| K122975 | GKS Prime Flex CR Total Knee System | 2012 | 0 |
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 16 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 9 of the 12 ancestors have a recall of any class.
- Of its descendants, K133919 (Consensus Orthopedics, Inc., 2014) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K073286.
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. 2011, 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 CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system, and is not intended for substitution of components from other systems.
A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110950: Consensus Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110950
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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