510(k) · Cleared
Recalled · Class II · 2018Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
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 Nov 25, 2015 as substantially equivalent to K946150 (Zimmer, Inc., 1995) and 1 other predicate after an 85-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it. It has been recalled once.
- Decided
- Nov 25, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945028 (1996). 3 ancestors in all, the oldest K946150 (1995). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 1 generation backK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · Recalled
- This deviceK152494 Zimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsZimmer, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK173057 Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · Recalled
- Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · cites it directly5descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
- K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · 2 generations on1descendant
- K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · 2 generations on0descendants
- K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −1 | K013385 | Nexgen Complete Knee Solution Rotatng Hinge Knee | Zimmer, Inc. | 2002 | 2 |
| 0 (this device) | K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments | Zimmer, Inc. | 2015 | — |
| +1 | K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | Zimmer, Inc. | 2018 | 2 |
| +1 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +2 | K191625 | Persona Revision Knee System | Zimmer, Inc. | 2019 | 1 |
| +2 | K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | Zimmer, Inc. | 2025 | — |
| +2 | K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K946150 | Cruciate Retaining (Augmentable) and Constrained Condylar Knee (CCK)Summary page 4…mplete Knee Solution Cruciate Retaining (Augmentable) and Legacy Constrained Condylar Knee, manufactured by Zimmer, Inc. (K946150) NexGen Complete Knee Solution Rotating Hinge Knee, manufactured by Zimmer, Inc.… | 1995 |
| * | K013385 | Nexgen Complete Knee Solution Rotatng Hinge KneeSummary page 4…manufactured by Zimmer, Inc. (K946150) NexGen Complete Knee Solution Rotating Hinge Knee, manufactured by Zimmer, Inc. (K013385) Purpose and Device The NexGen augments are used with the following Description: NexGen Knee Systems: === Page… | 2002 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2018 | Class II | Z-0630-2019 | Process control | Screw is missing from the package |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 13.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K173057 (Zimmer, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K946150.
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. 2015, 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?
For NexGen Augments used with NexGen Knee Systems – Cruciate Retaining (CR), Cruciate Retaining Augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK): 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. –…
Read the full statement (256 words)
For NexGen Augments used with NexGen Knee Systems – Cruciate Retaining (CR), Cruciate Retaining Augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK):
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.
• CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.
• NexGen Augments that may be used with cemented CR, CRA, PS, LPS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.
For NexGen Augments used with NexGen Rotating Hinge Knee System:
This device is indicated for patients with:
– Moderate to severe knee instability.
– Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
– Valgus, varus, or flexion deformities.
– The salvage of previously failed surgical attempts.
This device is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152494: Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152494
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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