510(k) · Cleared
Recalled · Class II · 2017U2 Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 1, 2006 as substantially equivalent to K021657 (United Orthopedic Corp., 2002) after a 254-day review. Its family tree reaches back 1 generation to 2002. 38 later devices descend from it. It has been recalled once.
- Decided
- Mar 1, 2006
- Review
- 254 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021657 (2002). 38 later devices descend from it, 16 citing it directly.
- Root · 1 generation backK021657 Uknee Total Knee SystemUnited Orthopedic Corp. · 2002
- This deviceK051640 U2 Total Knee SystemUnited Orthopedic Corp. · 2006
- Descendant · cites it directly · 15 of its ownK082424 United U2 Total Knee SystemUnited Orthopedic Corp. · 2008 · Recalled
- Descendant · cites it directly · 11 of its ownK123339 TK1 Total Knee SystemNovosource, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK142649 Progressive Orthopedic Total Knee SystemThe Progressive Orthopaedic Company, LLC · 2015
- Descendant · cites it directly · 10 of its ownK131398 Novoknee Total Knee SystemNovosource, Inc. · 2013
- Descendant · 2 generations on · 10 of its ownK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K082424United U2 Total Knee SystemUnited Orthopedic Corp. · 2008 · cites it directly15descendants
- K123339TK1 Total Knee SystemNovosource, Inc. · 2013 · cites it directly11descendants
- K142649Progressive Orthopedic Total Knee SystemThe Progressive Orthopaedic Company, LLC · 2015 · cites it directly10descendants
- K131398Novoknee Total Knee SystemNovosource, Inc. · 2013 · cites it directly10descendants
- K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021657 | Uknee Total Knee System | United Orthopedic Corp. | 2002 | — |
| 0 (this device) | K051640 | U2 Total Knee System | United Orthopedic Corp. | 2006 | — |
| +1 | K082424 | United U2 Total Knee System | United Orthopedic Corp. | 2008 | 2 |
| +1 | K123339 | TK1 Total Knee System | Novosource, Inc. | 2013 | — |
| +1 | K142649 | Progressive Orthopedic Total Knee System | The Progressive Orthopaedic Company, LLC | 2015 | — |
| +1 | K131398 | Novoknee Total Knee System | Novosource, Inc. | 2013 | — |
| +2 | K122183 | Augment and Screw, Psa Type | United Orthopedic Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K021657 | Uknee Total Knee SystemSummary page 1…ted prosthesis per 21CFR 888.3560. This falls under the Orthopedics panel/87. Predicate Device: United UKNEE Total Knee System (K021657) The data that United Orthopedic Corporation included in this submission show the U2 Total Knee System (Cruciate retaining ty… | 2002 |
What descends from it? (38)
See all 3816 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082424 | United U2 Total Knee System | 2008 | 15 |
| K123339 | TK1 Total Knee System | 2013 | 11 |
| K142649 | Progressive Orthopedic Total Knee System | 2015 | 10 |
| K131398 | Novoknee Total Knee System | 2013 | 10 |
| K103733 | United U2 Xpe Total Knee System | 2011 | 8 |
| K132752 | Ultracongruent Insert | 2014 | 5 |
| K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | 2014 | 5 |
| K140073 | U2 Femoral Component, CR, Cemented | 2014 | 4 |
| K120507 | United U2 Femoral Component, PS, #7 | 2012 | 4 |
| K170753 | Acculoc Total Knee System | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2017 | Class II | Z-1128-2018 | Labeling mix-ups | UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. |
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 indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature 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, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion…
Read the full statement (106 words)
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature 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, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, 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.
This device system is designed for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051640 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051640: U2 Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051640
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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