510(k) · Cleared
ClearedConsensus Knee System with TiNbN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shalby Advanced Technologies · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jan 14, 2025 as substantially equivalent to K110950 (Consensus Orthopedics, Inc., 2011) and 3 other predicates after a 260-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Jan 14, 2025
- Review
- 260 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K933785 (1995). 39 ancestors in all, the oldest K810520 (1981). 1 later device descends from it, 1 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 deviceK241180 Consensus Knee System with TiNbNShalby Advanced Technologies · 2025
- Descendant · cites it directly · 0 of its ownK260796 Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026
Most influential descendants
Showing 1 of 1 · See all- K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026 · cites it directly0descendants
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) | K241180 | Consensus Knee System with TiNbN | Shalby Advanced Technologies | 2025 | — |
| +1 | K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K110950 | Consensus Knee SystemSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K110950, K001456 111 I Consensus Knee System (CKS) 1… | 2011 |
| * | K001456 | Consensus Knee SystemSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K110950, K001456 111 I Consensus Knee System (CKS) 1 1 JWH, M… | 2000 |
| * | K182251 | EVOLUTION NitrX Medial-Pivot KneeSummary page 5…Product Code I K110950, K001456 111 I Consensus Knee System (CKS) 1 1 JWH, MBH IK182251 , K122239 1 1 EVOLUTION NitrX Medial-Pivot Knee, Foundation, Foundation ulIJWH Device Descri… | 2019 |
| * | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Summary page 5…Code I K110950, K001456 111 I Consensus Knee System (CKS) 1 1 JWH, MBH IK182251 , K122239 1 1 EVOLUTION NitrX Medial-Pivot Knee, Foundation, Foundation ulIJWH Device Description Summ… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | 2026 | 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 30 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 21 of the 39 ancestors have a recall of any class.
- Of its descendants, K260796 (Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics, 2026) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K110950.
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. 2025, 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 indications for use are:
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 non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement
E. 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/K241180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241180: Consensus Knee System with TiNbN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241180
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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