510(k) · Cleared
ClearedProlong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 27, 2001 as substantially equivalent to K003910 (Zimmer, Inc., 2001) after a 23-day review. Its family tree reaches back 1 generation to 2001. 203 later devices descend from it.
- Decided
- Dec 27, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003910 (2001). 203 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK003910 Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate…Zimmer, Inc. · 2001 · Recalled
- This deviceK013991 Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR)…Zimmer, Inc. · 2001
- Descendant · cites it directly · 123 of its ownK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · cites it directly · 79 of its ownK060722 Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing…Zimmer, Inc. · 2006
- Descendant · 2 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
Showing 5 of 203 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 203 · See all- K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · cites it directly123descendants
- K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · 2 generations on117descendants
- K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · 2 generations on96descendants
- K060722Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface…Zimmer, Inc. · 2006 · cites it directly79descendants
- K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · 2 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003910 | Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining… | Zimmer, Inc. | 2001 | 65 |
| 0 (this device) | K013991 | Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular… | Zimmer, Inc. | 2001 | — |
| +1 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| +2 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| +2 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| +1 | K060722 | Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular… | Zimmer, Inc. | 2006 | — |
| +2 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 9 | 0 |
| 2012 | 13 | 0 |
| 2013 | 12 | 0 |
| 2014 | 13 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 15 | 0 |
| 2021 | 23 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 17 | 0 |
| 2026 | 16 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003910 | Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR)…Summary page 1…device for the Prolong CR Articular Surface Component is the NexGen® Complete Knee Solution Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K003910, cleared March 19, 2001. These components are manufactured of machined Ultra-High Molecular-Weight (UHMWPE) polyethylene. Both t… | 2001 |
What descends from it? (203)
See all 2034 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070214 | Gender Solutions Natural-Knee Flex System | 2007 | 123 |
| K060722 | Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface… | 2006 | 79 |
| K042271 | Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular… | 2004 | 16 |
| K103733 | United U2 Xpe Total Knee System | 2011 | 8 |
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?
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.
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 intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for 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, posttrawmatic loss of joint configuration, particularly when there is patellofemoral…
Read the full statement (120 words)
This device is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for 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, posttrawmatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellcctomy, 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.
Prolong crosslinked polyethylene cruciate retaining articular surfaces are intended to be used as part of a cemented knee system.
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/K013991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013991: Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013991
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026