510(k) · Cleared
ClearedWorld Knee Total Knee Systems
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 Nov 27, 2019 as substantially equivalent to K180750 (Signature Orthopaedics Pty, Ltd., 2018) and 5 other predicates after a 266-day review. Its family tree reaches back 3 generations to 1998. 5 later devices descend from it.
- Decided
- Nov 27, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K971206 (1998). 13 ancestors in all, the oldest K951987 (1995). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971206 Meridian ST Femoral Stem and Vitalock Solid Back Shell W/…Howmedica Corp. · 1998 · Recalled
- 2 generations backK023302 Echelon Porous Plus HA Hip StemsSmith & Nephew, Inc. · 2002
- 1 generation backK032683 Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc. · 2003
- This deviceK190577 World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd. · 2019
- Descendant · cites it directly · 4 of its ownK220737 World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee…Signature Orthopaedics Pty, Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK240683 Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK260063 GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
- Descendant · 3 generations on · 0 of its ownK261734 Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253239 Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd. · 2022 · cites it directly4descendants
- K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024 · 2 generations on2descendants
- K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026 · 3 generations on0descendants
- K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc. · 2026 · 3 generations on0descendants
- K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating | Howmedica Corp. | 1998 | 1 |
| −2 | K023302 | Echelon Porous Plus HA Hip Stems | Smith & Nephew, Inc. | 2002 | — |
| −1 | K032683 | Genesis II Porous Plus HA Knee System | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| +1 | K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E… | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| +2 | K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +3 | K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | 2026 | — |
| +3 | K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (6)
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 |
|---|---|---|---|
| * | K180750 | World Knee SystemSummary page 4…Devices: Primary Predicate: • Signature Orthopaedics World Total Knee System (K180750 & K181530) • Signature Orthopaedics Genius Total Knee System… | 2018 |
| * | K181530 | World Total Knee SystemSummary page 4…Primary Predicate: • Signature Orthopaedics World Total Knee System (K180750 & K181530) • Signature Orthopaedics Genius Total Knee System… | 2018 |
| * | K170613 | Genius Total Knee SystemSummary page 4…(K180750 & K181530) • Signature Orthopaedics Genius Total Knee System (K170613) Secondary Predicates: • Signature Orthopaedics Active-X Knee… | 2017 |
| * | K160159 | Active-X Total Knee SystemSummary page 4…(K170613) Secondary Predicates: • Signature Orthopaedics Active-X Knee System (K160159) • Smith & Nephew Genesis II Total Knee System (K030612 &… | 2016 |
| * | K030612 | Genesis II Total Knee SystemSummary page 4…• Signature Orthopaedics Active-X Knee System (K160159) • Smith & Nephew Genesis II Total Knee System (K030612 & K032683) Reference Predicate:… | 2003 |
| * | K032683 | Genesis II Porous Plus HA Knee SystemSummary page 4…hopaedics Active-X Knee System (K160159) • Smith & Nephew Genesis II Total Knee System (K030612 & K032683) Reference Predicate: • Signature Orthopaedics Pegasus Stem (… | 2003 |
| † | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem… | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal… | 2022 | 4 |
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 21 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K220737 (Signature Orthopaedics Pty, Ltd., 2022) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K180750.
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. 2019, 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 World Knee replacement system. 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…
Read the full statement (107 words)
The patient should be skeletally mature to receive a World Knee replacement system.
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.
• Fractures that are unmanageable using other techniques.
The World Knee replacement system is indicated for cemented fixation with bone cement
(PMMA) only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190577: World Knee Total Knee Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190577
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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