510(k) · Cleared
ClearedActive-X 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 Sep 6, 2016 as substantially equivalent to K021740 (Dj Orthopedics, LLC, 2002) after a 223-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Sep 6, 2016
- Review
- 223 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973412 (1997). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK973412 Natural-Knee II Constrained Knee SystemSulzer Orthopedics, Inc. · 1997 · Recalled
- 1 generation backK021740 Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC · 2002
- This deviceK160159 Active-X Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2016
- 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 |
|---|---|---|---|---|---|
| −2 | K973412 | Natural-Knee II Constrained Knee System | Sulzer Orthopedics, Inc. | 1997 | 2 |
| −1 | K021740 | Total Knee Cemented, Semi-Constrained | Dj Orthopedics, LLC | 2002 | — |
| 0 (this device) | K160159 | Active-X Total Knee System | Signature Orthopaedics Pty, Ltd. | 2016 | — |
| +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? (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.
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)
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 19 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K190577 (Signature Orthopaedics Pty, Ltd., 2019) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K021740.
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. 2016, 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 (105 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.
The Active-X 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/K160159 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160159: Active-X Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160159
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