510(k) · Cleared
Recalled · Class II · 2026United U2 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 Dec 16, 2008 as substantially equivalent to K051640 (United Orthopedic Corp., 2006) and 1 other predicate after a 116-day review. Its family tree reaches back 2 generations to 2002. 15 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 16, 2008
- Review
- 116 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021657 (2002). 3 ancestors in all, the oldest K960279 (1996). 15 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK021657 Uknee Total Knee SystemUnited Orthopedic Corp. · 2002
- 1 generation backK051640 U2 Total Knee SystemUnited Orthopedic Corp. · 2006 · Recalled
- This deviceK082424 United U2 Total Knee SystemUnited Orthopedic Corp. · 2008
- Descendant · cites it directly · 10 of its ownK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
- Descendant · cites it directly · 5 of its ownK131864 U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
- Descendant · 2 generations on · 3 of its ownK150829 U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015
- Descendant · cites it directly · 3 of its ownK100981 United Stem, Psa TypeUnited Orthopedic Corp. · 2010
- Descendant · cites it directly · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013 · cites it directly10descendants
- K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014 · cites it directly5descendants
- K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015 · 2 generations on3descendants
- K100981United Stem, Psa TypeUnited Orthopedic Corp. · 2010 · cites it directly3descendants
- K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021657 | Uknee Total Knee System | United Orthopedic Corp. | 2002 | — |
| −1 | K051640 | U2 Total Knee System | United Orthopedic Corp. | 2006 | 1 |
| 0 (this device) | K082424 | United U2 Total Knee System | United Orthopedic Corp. | 2008 | — |
| +1 | K122183 | Augment and Screw, Psa Type | United Orthopedic Corp. | 2013 | — |
| +1 | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | United Orthopedic Corporation | 2014 | — |
| +2 | K150829 | U2 Total Knee System- Additional Sizes | United Orthopedic Corporation | 2015 | — |
| +1 | K100981 | United Stem, Psa Type | United Orthopedic Corp. | 2010 | — |
| +1 | K190100 | USTAR II System | United Orthopedic Corporation | 2019 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K051640 | U2 Total Knee SystemSummary page 4…and effectiveness of U2 Total Knee system - PSA Type are substantial equivalence to the "UNITED" U2 Total Knee System - PS Type which was previously cleared by FDA (K051640). In addition, U2 Total Knee system - PSA Type is also substantial equivalence to the "ZIMMER" NexGen Complete Knee Solution Le… | 2006 |
| * | K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…Summary page 1…1. "UNITED" U2 Total Knee system (KO51640) 2. "ZIMMER" NexGen Complete Knee Solution Legacy CCK Type (K960279) U2 Total Knee System - Posterior Stabilized Augmentable (PSA) Type is intended for use in patients who require augmentation a… | 1996 |
What descends from it? (15)
See all 159 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122183 | Augment and Screw, Psa Type | 2013 | 10 |
| K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | 2014 | 5 |
| K100981 | United Stem, Psa Type | 2010 | 3 |
| K190100 | USTAR II System | 2019 | 2 |
| K161705 | U2 Total Knee System E-XPE products | 2017 | 1 |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | 2025 | 0 |
| K210695 | CPM Medical Consultants Tibial Revision Knee System | 2021 | 0 |
| K161360 | U2 Total Knee System, PSA Tibial Insert | 2017 | 0 |
| K131116 | U2 Total Knee System - Psa Type, Offset Stem Adapter | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2026 | Class II | Z-2883-2026 | Process design | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| Nov 24, 2017 | Class II | Z-1129-2018 | 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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K122183 (United Orthopedic Corp., 2013) has gone furthest, with 10 descendants of its own.
- 15 other devices also cite its predicate K051640.
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. 2008, 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?
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 (100 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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082424: United U2 Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082424
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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