510(k) · Cleared
ClearedTriVerse Total Knee Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 4, 2022 as substantially equivalent to K113550 (Biomet Manufacturing Corp, 2012) after a 60-day review. Its family tree reaches back 7 generations to 1981. 1 later device descends from it.
- Decided
- Oct 4, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K810258 (1981). 41 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 4 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 3 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 2 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 1 generation backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- This deviceK222380 TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK253239 Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −6 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −5 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −4 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −3 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −2 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −1 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
| 0 (this device) | K222380 | TriVerse Total Knee Replacement System | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| +1 | K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K113550 | Vanguard Complete Knee SystemSummary page 4…prosthesis. (OIY, 21 CFR 888.3560) Predicate Devices: Primary Predicate • Biomet Vanguard Total Knee System (K113550) Reference Devices • Signature Orthopaedics World Knee Syst… | 2012 |
| † | K181530 | World Total Knee System | 2018 |
| † | K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal… | 2022 |
| † | K160159 | Active-X Total Knee System | 2016 |
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 |
|---|---|---|---|
| K253239 | Active-V Total Knee System; World Total Knee System | 2025 | 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 41 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 14 of the 41 ancestors have a recall of any class.
- Of its descendants, K253239 (Signature Orthopaedics Pty, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K113550.
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. 2022, 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 patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: - Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. - Inflammatory degenerative joint disease including rheumatoid arthritis. -…
Read the full statement (96 words)
The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.
The patient's need for knee replacement should be due to one or more of the following conditions:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- Inflammatory degenerative joint disease including rheumatoid arthritis.
- Functional deformity such as varus, valgus or flexion deformities.
- Revision procedures where other treatments or devices have failed.
Signature Orthopaedics' TriVerse Total Knee Replacement System components are indicated for cemented application only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222380: TriVerse Total Knee Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222380
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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