510(k) · Cleared
ClearedProlixus Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otis Biotech Co., Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 9, 2017 as substantially equivalent to K863668 (Osteonics Corp., 1986) and 4 other predicates after a 259-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 9, 2017
- Review
- 259 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K933785 (1995). 6 ancestors in all, the oldest K863668 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 1 generation backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- This deviceK170534 Prolixus Total Knee SystemOtis Biotech Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK231975 PNK Total Knee SystemTjc Life Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK191192 SurgTech GENOLL Total Knee SystemSurgtech, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −1 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| 0 (this device) | K170534 | Prolixus Total Knee System | Otis Biotech Co., Ltd. | 2017 | — |
| +1 | K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | 2023 | — |
| +1 | K191192 | SurgTech GENOLL Total Knee System | Surgtech, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K863668 | Omnifit (TM) Total Knee Prosthesis SystemSummary page 4…Submission Clearance date Number Osteonics Corp Omnifit® Total K863668 12/19/1986 Knee System Stryker Orthopaedics Duracon® Total… | 1986 |
| * | K032163 | Duracon Total Knee SystemSummary page 4…Omnifit® Total K863668 12/19/1986 Knee System Stryker Orthopaedics Duracon® Total K032163 09/12/2003 (Howmedica Knee System Osteonics Corp) Triathlon™… | 2003 |
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 4…Duracon® Total K032163 09/12/2003 (Howmedica Knee System Osteonics Corp) Triathlon™ K040267 05/05/2004 Cruciate Retaining Artificial Joint Research Center OTISBiotech co., L… | 2004 |
| * | K933785 | Next Generation Knee SystemSummary page 5…007. 510(k) Summary (CR) Total Knee System Zimmer, Inc NexGen CR knee K933785 30/01/1995 NexGen ( CR) - K023211 17/10/2002… | 1995 |
| * | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsSummary page 5…System Zimmer, Inc NexGen CR knee K933785 30/01/1995 NexGen ( CR) - K023211 17/10/2002 Flex Femoral components Otis Biotech… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 2 companies; a new generation was cleared every 15.1 years on median.
- 6 of the 6 ancestors have a recall of any class.
- Of its descendants, K231975 (Tjc Life Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K863668.
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?
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion…
Read the full statement (106 words)
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cement use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170534: Prolixus 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/K170534
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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