510(k) · Cleared
Recalled · 20103D KNEE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 12, 2002 as substantially equivalent to K923277 (Encore Orthopedics, Inc., 1993) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 1993. 143 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 12, 2002
- Review
- 182 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923277 (1993). 2 ancestors in all. 143 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
- This deviceK020114 3D KNEEEncore Orthopedics, Inc. · 2002
- Descendant · cites it directly · 119 of its ownK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- Descendant · cites it directly · 72 of its ownK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
- Descendant · 2 generations on · 38 of its ownK130365 X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013
- Descendant · 2 generations on · 37 of its ownK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- Descendant · 2 generations on · 35 of its ownK123982 Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P. · 2013
Showing 5 of 143 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 143 · See all- K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. · 2010 · cites it directly119descendants
- K100900Motivation Knee SystemEncore Medical L.P. · 2010 · cites it directly72descendants
- K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013 · 2 generations on38descendants
- K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010 · 2 generations on37descendants
- K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P. · 2013 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923277 | Foundation Knee System | Encore Orthopedics, Inc. | 1993 | 4 |
| 0 (this device) | K020114 | 3D KNEE | Encore Orthopedics, Inc. | 2002 | — |
| +1 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| +1 | K100900 | Motivation Knee System | Encore Medical L.P. | 2010 | 4 |
| +2 | K130365 | X-Alt Highly Cross Linked VE Acetabular Liner | Encore Medical L.P. | 2013 | — |
| +2 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| +2 | K123982 | Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+ | Encore Medical L.P. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 11 | 0 |
| 2015 | 4 | 0 |
| 2016 | 9 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 8 | 0 |
| 2020 | 12 | 0 |
| 2021 | 21 | 0 |
| 2022 | 13 | 0 |
| 2023 | 14 | 0 |
| 2024 | 3 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K923277 | Foundation Knee SystemSummary page 1…emorotibial, semiconstrained, cemented, polymer, metal, polymer (3) Legally marketed predicate device: Foundation Knee System (K923277) Lateral Pivot Insert (K000590) (4) Subject device description: The 3 0 Knee i… | 1993 |
| * | K000590 | Lateral Pivot InsertSummary page 1…polymer, metal, polymer (3) Legally marketed predicate device: Foundation Knee System (K923277) Lateral Pivot Insert (K000590) (4) Subject device description: The 3 0 Knee is comprised of a femoral and a tibial component. The femoral component i… | 2000 |
What descends from it? (143)
See all 1437 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | 2010 | 119 |
| K100900 | Motivation Knee System | 2010 | 72 |
| K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating… | 2013 | 20 |
| K143242 | Rebel 3DKNEE System | 2015 | 11 |
| K191765 | OMNI TiN Coated Apex Knee™ System | 2019 | 2 |
| K032905 | 3DKNEE Porous Coated Femoral Component | 2004 | 2 |
| K121835 | Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VE | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2010 | Not classified | Z-2244-2010 | Labeling mix-ups | One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing. |
| Mar 19, 2010 | Not classified | Z-1433-2010 | Packaging process control | Affected product had incorrect color label which is a secondary visual indicator for sizing. |
| Feb 20, 2008 | Not classified | Z-1539-2008 | Error in labeling | Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side. |
| Nov 3, 2005 | Not classified | Z-0332-06 | Other | The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function. |
| May 10, 2004 | Not classified | Z-1011-04 | Other | Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE |
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 part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis Avascular necrosis…
Read the full statement (103 words)
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
Noninflammatory degenerative joint disease including osteoarthritis or traumatic 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
Rheumatoid arthritis
Treatment of fractures that are unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020114: 3D KNEE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020114
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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