510(k) · Cleared
ClearedWorld Total Knee 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 24, 2018 after a 135-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Oct 24, 2018
- Review
- 135 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK181530 World Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2018
- Descendant · cites it directly · 5 of its ownK190577 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 · cites it directly · 2 of its ownK240683 Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK241690 Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK260063 GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd. · 2019 · cites it directly5descendants
- 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 · cites it directly2descendants
- K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024 · cites it directly2descendants
- K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K181530 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2018 | — |
| +1 | 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 | — |
| +1 | K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +1 | K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +2 | K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | — | Signature Orthopaedics World Knee System Named without a submission number | |
| * | — | Signature Orthopaedics Genius Knee System Named without a submission number | |
| * | — | S&N Surgical Knee System Named without a submission number | |
| * | — | Total Knee System Named without a submission number | |
| * | — | Smith & Nephew Knee System Named without a submission number | |
| † | K951987 | Genesis II Total Knee System | 1995 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190577 | World Knee Total Knee Systems | 2019 | 5 |
| K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal… | 2022 | 4 |
| K240683 | Rx Knee System | 2024 | 2 |
| K241690 | Logical Liner; World Liner; World Knee Patella | 2024 | 2 |
| 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?
- Of its descendants, K190577 (Signature Orthopaedics Pty, Ltd., 2019) has gone furthest, with 5 descendants of its own.
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. 2018, 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 (122 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.
* Fractures that are unmanageable using other techniques.
Signature Orthopaedics’ World Knee replacement components may be intended for cemented or
cementless use. Please verify whether the particular component is intended for cemented or cementless
use by checking the package label.
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/K181530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181530: World Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181530
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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