510(k) · Cleared
Recalled · Class II · 2018Genius 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 Jul 17, 2017 after a 138-day review. The FDA summary names no predicate by number. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 17, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK170613 Genius Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2017
- Descendant · cites it directly · 5 of its ownK190577 World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd. · 2019
- Descendant · 2 generations on · 4 of its ownK220737 World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee…Signature Orthopaedics Pty, Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK240683 Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK260063 GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
- Descendant · 4 generations on · 0 of its ownK261734 Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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 · 2 generations on4descendants
- K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024 · 3 generations on2descendants
- K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026 · 4 generations on0descendants
- K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170613 | Genius Total Knee System | Signature Orthopaedics Pty, Ltd. | 2017 | — |
| +1 | K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| +2 | K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E… | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| +3 | K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +4 | K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | 2026 | — |
| +4 | K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (6)
1 later device cites 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 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2018 | Class II | Z-0833-2019 | Mixed-up of materials/components | Product mix up |
| Dec 10, 2018 | Class II | Z-0834-2019 | Mixed-up of materials/components | Product mix up |
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. 2017, 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 Genius Knee System is intended for use in total knee replacement. Patients should be skeletally mature and have adequate bone stock and soft tissue support and accept the prosthesis. The patient's need for replacement should be due to one or more of the following conditions: • Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis. • Inflammatory degenerative joint disease including rheumatoid…
Read the full statement (107 words)
The Genius Knee System is intended for use in total knee replacement. Patients should be skeletally mature and have adequate bone stock and soft tissue support and accept the prosthesis. The patient's need for replacement should be due to one or more of the following conditions:
• Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 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 Genius Knee replacement system is indicated for cemented fixation with cement (PMMA) only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170613: Genius 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/K170613
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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