510(k) · Cleared
Recalled · Class II · 2025Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces
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 Oct 13, 2004 as substantially equivalent to K991581 (Zimmer, Inc., 1999) and 2 other predicates after a 51-day review. Its family tree reaches back 3 generations to 1995. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 13, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K933785 (1995). 7 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 2 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 1 generation backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- This deviceK042271 Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked…Zimmer, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK123459 Zimmer Persona TM Personalized Knee SystemZimmer, Inc. · 2013 · Recalled
- Descendant · cites it directly · 5 of its ownK173057 Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK222566 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK131310 GMK Full PE Tibial ComponentsMedacta International · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc. · 2013 · cites it directly9descendants
- K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · cites it directly5descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 2 generations on4descendants
- K222566Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2022 · 2 generations on2descendants
- K131310GMK Full PE Tibial ComponentsMedacta International · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −2 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −1 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| 0 (this device) | K042271 | Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene… | Zimmer, Inc. | 2004 | — |
| +1 | K123459 | Zimmer Persona TM Personalized Knee System | Zimmer, Inc. | 2013 | 10 |
| +1 | K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | Zimmer, Inc. | 2018 | 2 |
| +2 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +2 | K222566 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +1 | K131310 | GMK Full PE Tibial Components | Medacta International | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing…Summary page 1…LPS-Flex Fixed Bearing Articular Surface Components, manufactured by Zimmer, Inc., K991581, cleared July 30, 1999. ProlongHighly Crosslinked Polyethylene Cruciate… | 1999 |
| * | K013991 | Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface…Summary page 1…olyethylene Cruciate Retaining (CR) Articular Surface Components, manufactured by Zimmer, Inc., K013991, cleared December 27, 2001. NexGen Porous, Uncemented… | 2001 |
| * | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsSummary page 1…exGen Porous, Uncemented Femoral and Tibial Baseplate Components, manufactured by Zimmer, Inc., K031061, cleared October 9, 2003. Device Description: The NexGen LPS-Flex Prolong articular surfaces… | 2003 |
What descends from it? (16)
See all 164 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2025 | Class II | Z-1433-2025 | Labeling Change Control | The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label. |
| Apr 16, 2010 | Not classified | Z-0609-2011 | Device Design | The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K123459 (Zimmer, Inc., 2013) has gone furthest, with 9 descendants of its own.
- 18 other devices also cite its predicate K991581.
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 indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy - Moderate valgus, varus or flexion deformities. - The salvage of previously failed surgical…
Read the full statement (108 words)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
The device is indicated for use when both cruciate ligaments have been excised.
The device is intended for use as part of a cemented or uncemented knee prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042271: Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042271
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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