510(k) · Cleared
Recalled · Class II · 2013United U2 Femoral Component, PS, #7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 4, 2012 as substantially equivalent to K051640 (United Orthopedic Corp., 2006) and 2 other predicates after a 73-day review. Its family tree reaches back 2 generations to 2002. 4 later devices descend from it. It has been recalled once.
- Decided
- May 4, 2012
- Review
- 73 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K021657 (2002). 4 ancestors in all, the oldest K951987 (1995). 4 later devices descend from it, 1 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 deviceK120507 United U2 Femoral Component, PS, #7United Orthopedic Corporation · 2012
- Descendant · cites it directly · 3 of its ownK150829 U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK161705 U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK222700 Tibial baseplate, Tibial insertUnited Orthopedic Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK210961 U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation · 2021
Most influential descendants
Showing 4 of 4 · See all- K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015 · cites it directly3descendants
- K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017 · 2 generations on1descendant
- K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation · 2022 · 2 generations on0descendants
- K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation · 2021 · 2 generations on0descendants
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) | K120507 | United U2 Femoral Component, PS, #7 | United Orthopedic Corporation | 2012 | — |
| +1 | K150829 | U2 Total Knee System- Additional Sizes | United Orthopedic Corporation | 2015 | — |
| +2 | K161705 | U2 Total Knee System E-XPE products | United Orthopedic Corporation | 2017 | — |
| +2 | K222700 | Tibial baseplate, Tibial insert | United Orthopedic Corporation | 2022 | — |
| +2 | K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | United Orthopedic Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (3)
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 2…. Fixation of the femoral component to the femur is achieved using bone cement. This device is intended to be used with the previously cleared U2 PS tibial insert (K051640), U2 XPE tibial inserts - PS type (K]12463), U2 tibial baseplate (K051640), U2 Patella components (K05l640, K08246… | 2006 |
| * | K972626 | Advance Knee SystemSummary page 1…: 1. "UNITED" U2'Total Knee System (KOS51640) 2. "Wright Medical Technology" Advance® Total Knee System (K972626) 3. " Smith & Nephew" Genesis 11 Knee System (K95 1987) Device Description: This device is an… | 1997 |
| * | K951987 | Genesis II Total Knee SystemSummary page 1…Wright Medical Technology" Advance® Total Knee System (K972626) 3. " Smith & Nephew" Genesis 11 Knee System (K95 1987) Device Description: This device is an additional size extension to the previously cleared "UNITED" U2 Total Knee System… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150829 | U2 Total Knee System- Additional Sizes | 2015 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2013 | Class II | Z-1378-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K150829 (United Orthopedic Corporation, 2015) has gone furthest, with 3 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. 2012, 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 (105 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 is intended for cemented use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120507 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120507: United U2 Femoral Component, PS, #7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120507
Report an extraction error
Are you the manufacturer?
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