510(k) · Cleared
Recalled · Class II · 2026Rebel 3DKNEE System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 15, 2015 as substantially equivalent to K020114 (Encore Orthopedics, Inc., 2002) and 5 other predicates after a 184-day review. Its family tree reaches back 8 generations to 1981. 11 later devices descend from it. It has been recalled 17 times.
- Decided
- May 15, 2015
- Review
- 184 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 17
- Predicates
- 6
Its longest line of descent runs back 8 generations to K810258 (1981). 41 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 4 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 3 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 2 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 1 generation backK121727 Movation Knee SystemEncore Medical L.P. · 2012
- This deviceK143242 Rebel 3DKNEE SystemEncore Medical L.P. · 2015
- Descendant · cites it directly · 6 of its ownK160342 EMPOWR PS Knee SystemEncore Medical L.P. · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK180930 Empowr VVC Tibial InsertEncore Medical L.P. · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK230169 EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis · 2023
- Descendant · cites it directly · 2 of its ownK173723 EMPOWR Universal Tibial BaseplateEncore Medical L.P. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK213793 EMPOWR Revision KneeEncore Medical L.P. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K160342EMPOWR PS Knee SystemEncore Medical L.P. · 2016 · cites it directly6descendants
- K180930Empowr VVC Tibial InsertEncore Medical L.P. · 2018 · 2 generations on3descendants
- K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis · 2023 · 3 generations on2descendants
- K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P. · 2018 · cites it directly2descendants
- K213793EMPOWR Revision KneeEncore Medical L.P. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −4 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −3 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −2 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −1 | K121727 | Movation Knee System | Encore Medical L.P. | 2012 | — |
| 0 (this device) | K143242 | Rebel 3DKNEE System | Encore Medical L.P. | 2015 | — |
| +1 | K160342 | EMPOWR PS Knee System | Encore Medical L.P. | 2016 | 5 |
| +2 | K180930 | Empowr VVC Tibial Insert | Encore Medical L.P. | 2018 | 1 |
| +3 | K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Encore Medical, L.P Dba Enovis | 2023 | — |
| +1 | K173723 | EMPOWR Universal Tibial Baseplate | Encore Medical L.P. | 2018 | 1 |
| +2 | K213793 | EMPOWR Revision Knee | Encore Medical L.P. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (6)
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 |
|---|---|---|---|
| * | K020114 | 3D KNEESummary page 4…ndicated in the salvage of previously failed surgical attempts. This device is intended to be used for cemented applications. Predicate Devices: 3DKNEE System - K020114 & K091956 Foundation Knee System - K923277 Foundation PS Knee System - K93353… | 2002 |
| * | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Summary page 4…n the salvage of previously failed surgical attempts. This device is intended to be used for cemented applications. Predicate Devices: 3DKNEE System - K020114 & K091956 Foundation Knee System - K923277 Foundation PS Knee System - K933539… | 2010 |
| * | K923277 | Foundation Knee SystemSummary page 4…device is intended to be used for cemented applications. Predicate Devices: 3DKNEE System - K020114 & K091956 Foundation Knee System - K923277 Foundation PS Knee System - K933539 Movation Knee System - K100900 & K121727… | 1993 |
| * | K933539 | Foundation Posterior Stabilized KneeSummary page 4…edicate Devices: 3DKNEE System - K020114 & K091956 Foundation Knee System - K923277 Foundation PS Knee System - K933539 Movation Knee System - K100900 & K121727 Comparable Features to Predicate Device(s): This device is c… | 1994 |
| * | K100900 | Motivation Knee SystemSummary page 4…Foundation Knee System - K923277 Foundation PS Knee System - K933539 Movation Knee System - K100900 & K121727 Comparable Features to Predicate Device(s): This device is comparable to the current 3DKNEE System in indications, m… | 2010 |
| * | K121727 | Movation Knee SystemSummary page 4…Foundation Knee System - K923277 Foundation PS Knee System - K933539 Movation Knee System - K100900 & K121727 Comparable Features to Predicate Device(s): This device is comparable to the current 3DKNEE System in indications, material, d… | 2012 |
What descends from it? (11)
See all 114 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 16, 2026 | Class II | Z-2701-2026 | Process change control | Due to packaging discrepancy with incorrect product size mixed up. |
| Feb 16, 2026 | Class II | Z-2700-2026 | Process change control | Due to packaging discrepancy with incorrect product size mixed up. |
| Jan 15, 2026 | Class II | Z-1459-2026 | Process control | Knee and Humeral socket implants contain incorrect labeling. |
| Jan 5, 2026 | Class II | Z-1233-2026 | Labeling Change Control | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices… |
| Jul 9, 2025 | Class II | Z-2286-2025 | Labeling Change Control | Knee implants contain incorrect labeling (size and/or side incorrect) |
| Jul 9, 2025 | Class II | Z-2285-2025 | Labeling Change Control | Knee implants contain incorrect labeling (size and/or side incorrect) |
| Jun 2, 2025 | Class II | Z-2126-2025 | Packaging change control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. |
| Jun 2, 2025 | Class II | Z-2125-2025 | Packaging change control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. |
| Dec 18, 2024 | Class II | Z-0766-2025 | Labeling Change Control | 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product. |
| Dec 10, 2024 | Class II | Z-0761-2025 | Labeling Change Control | Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product. |
| Aug 22, 2023 | Class II | Z-0102-2024 | Labeling Change Control | Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs… |
| Aug 12, 2022 | Class II | Z-0126-2023 | Process control | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery. |
| May 5, 2022 | Class II | Z-1257-2022 | Labeling mix-ups | A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space. |
| May 12, 2021 | Class II | Z-2104-2021 | Mixed-up of materials/components | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. |
| May 12, 2021 | Class II | Z-2103-2021 | Mixed-up of materials/components | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. |
| Feb 5, 2021 | Class II | Z-1524-2021 | Nonconforming Material/Component | Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction. |
| Nov 15, 2016 | Class II | Z-0711-2017 | Mixed-up of materials/components | A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 18 of the 41 ancestors have a recall of any class.
- Of its descendants, K160342 (Encore Medical L.P., 2016) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K020114.
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?
Joint replacement is indicated for patients suffering from disability due to:
degenerative, post-traumatic or rheumatoid arthritis;
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;
treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used for cemented applications.
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/K143242 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143242: Rebel 3DKNEE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143242
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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