510(k) · Cleared
ClearedActive-V Total Knee System; World Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Dec 23, 2025 as substantially equivalent to K181530 (Signature Orthopaedics Pty, Ltd., 2018) and 3 other predicates after an 85-day review. Its family tree reaches back 8 generations to 1981.
- Decided
- Dec 23, 2025
- Review
- 85 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K810258 (1981). 55 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 4 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 3 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 2 generations backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- 1 generation backK222380 TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd. · 2022
- This deviceK253239 Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −4 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −3 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −2 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
| −1 | K222380 | TriVerse Total Knee Replacement System | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 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 20.0 · 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? (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 |
|---|---|---|---|
| * | K181530 | World Total Knee SystemSummary page 5…Total Knee System Primary Predicate Signature Orthopaedics, World Total Knee System (K181530) Additional Predicates Signature Orthopaedics, World Total Knee System… | 2018 |
| * | K223062 | World Total Knee SystemSummary page 5…(K181530) Additional Predicates Signature Orthopaedics, World Total Knee System (K223062) Signature Orthopaedics, Triverse Total Knee System (K222380) ===… | 2022 |
| * | K222380 | TriVerse Total Knee Replacement SystemSummary page 5…l Knee System (K223062) Signature Orthopaedics, Triverse Total Knee System (K222380) K253239 - Page 2 of 4 Referenc… | 2022 |
| * | K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Summary page 6…(K181530) Additional Predicates Signature Orthopaedics, World Total Knee System (K220737, K223062) Reference Device Signature Orthopaedics, Rx Knee System… | 2022 |
| † | K243680 | Neurovascular Insight V1.0 | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 44 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 17 of the 55 ancestors have a recall of any class.
- 4 other devices also cite its predicate K181530.
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. 2025, 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 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 needs 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…
Read the full statement (99 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 needs 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 device have failed
Fractures that are unmanageable using other techniques
Signature Orthopaedics' Active-V/World Total Knee components may be intended for cemented and cementless use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253239: Active-V Total Knee System; World Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253239
Report an extraction error
Are you the manufacturer?
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