510(k) · Cleared
ClearedConsensus Vitalite Tibial Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consensus Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 14, 2014 as substantially equivalent to K932837 (U.S. Medical Products, Inc., 1994) and 3 other predicates after a 203-day review. Its family tree reaches back 6 generations to 1995. 7 later devices descend from it.
- Decided
- Jul 14, 2014
- Review
- 203 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K933785 (1995). 17 ancestors in all, the oldest K912663 (1991). 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 5 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 4 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 3 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 2 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 1 generation backK110950 Consensus Knee SystemConsensus Orthopedics, Inc. · 2011
- This deviceK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK163167 CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 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
- Descendant · 2 generations on · 1 of its ownK191084 The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017 · cites it directly3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 2 generations on2descendants
- K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016 · cites it directly2descendants
- K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020 · 2 generations on1descendant
- K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −5 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −4 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −3 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −2 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −1 | K110950 | Consensus Knee System | Consensus Orthopedics, Inc. | 2011 | — |
| 0 (this device) | K133919 | Consensus Vitalite Tibial Insert | Consensus Orthopedics, Inc. | 2014 | — |
| +1 | K163167 | CKS Plus Knee System | Consensus Orthopedics, Inc. | 2017 | — |
| +2 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| +1 | K160515 | PS2 Knee System | Consensus Orthopedics, Inc. | 2016 | — |
| +2 | K191084 | The Optimotion Blue Total Knee System | Optimotion Implants, LLC | 2020 | — |
| +3 | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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 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? (4)
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 |
|---|---|---|---|
| * | K932837 | Consensus Knee System - Primary KneeSummary page 2…ce: Technological Characteristics/ Substantial Equivalence: The new VitalitE tibial insert is the exact same design as cleared for use with the Consensus Knee System in K932837, K953443 & KI 110950 and also with the Consensus Revision Knee in K1 00542 and is compatible with all of the metallic -femoral an… | 1994 |
| * | K953443 | Consensus PCL Subsituting Tibial InsertSummary page 2…nological Characteristics/ Substantial Equivalence: The new VitalitE tibial insert is the exact same design as cleared for use with the Consensus Knee System in K932837, K953443 & KI 110950 and also with the Consensus Revision Knee in K1 00542 and is compatible with all of the metallic -femoral and tibial… | 1996 |
| * | K110950 | Consensus Knee SystemSummary page 2…racteristics/ Substantial Equivalence: The new VitalitE tibial insert is the exact same design as cleared for use with the Consensus Knee System in K932837, K953443 & KI 110950 and also with the Consensus Revision Knee in K1 00542 and is compatible with all of the metallic -femoral and tibial components f… | 2011 |
| * | K100542 | Consensus Revision Knee SystemSummary page 2…itE tibial insert is the exact same design as cleared for use with the Consensus Knee System in K932837, K953443 & KI 110950 and also with the Consensus Revision Knee in K1 00542 and is compatible with all of the metallic -femoral and tibial components from those systems. The UHMWPE (GUR 1020) with a-tocoph… | 2010 |
| † | K130652 | Vitalite E Cross-Linked Polyethylene Acetabular Insert | 2013 |
| † | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | 2010 |
| † | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | 2010 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3.3 years on median.
- 9 of the 17 ancestors have a recall of any class.
- Of its descendants, K163167 (Consensus Orthopedics, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K932837.
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. 2014, 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?
When used with the components of the Consensus Knee System: 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, osteoiarthritis, post-traumatic arthritis, or degenerative arthritis. B. Failed osteotomny or unicompartnental replacements. C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient…
Read the full statement (235 words)
When used with the components of the Consensus Knee System:
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, osteoiarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomny or unicompartnental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
When used as a component of the Consensus Revision Knee System:
The Consensus®l Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus®D Knee System. The revision knee femoral and tibial components are intended for cemented use only.
The indications for use are:
A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
B. Post-traumatic loss ofjoint configuration (particularly when there is patellofemorall erosion, dysfunction, or prior patellectomy)
C. Failed osteotomy or unicompartmental replacements.
D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
F. Moderate valgus. vanis, or flexion deformities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133919: Consensus Vitalite Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133919
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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