510(k) · Cleared
ClearedU2 Total Knee System- Additional Sizes
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 Sep 25, 2015 as substantially equivalent to K051640 (United Orthopedic Corp., 2006) and 5 other predicates after a 179-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.
- Decided
- Sep 25, 2015
- Review
- 179 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K915132 (1992). 42 ancestors in all, the oldest P830055 (1985). 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 5 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- 4 generations backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
- 3 generations backK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
- 2 generations backK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
- 1 generation backK131864 U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
- This deviceK150829 U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015
- Descendant · cites it directly · 1 of its ownK161705 U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017
- Descendant · cites it directly · 0 of its ownK222700 Tibial baseplate, Tibial insertUnited Orthopedic Corporation · 2022
- Descendant · cites it directly · 0 of its ownK210961 U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017 · cites it directly1descendant
- K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation · 2022 · cites it directly0descendants
- K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −5 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| −4 | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | 1 |
| −3 | K093293 | Vanguard 360 Revision Knee System | Biomet, Inc. | 2010 | 5 |
| −2 | 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 | — |
| 0 (this device) | K150829 | U2 Total Knee System- Additional Sizes | United Orthopedic Corporation | 2015 | — |
| +1 | K161705 | U2 Total Knee System E-XPE products | United Orthopedic Corporation | 2017 | — |
| +1 | K222700 | Tibial baseplate, Tibial insert | United Orthopedic Corporation | 2022 | — |
| +1 | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K051640 | U2 Total Knee SystemSummary page 4…ice Class Class II Classification Panel Orthopaedics Product Code JWH Predicate Device 1. “UNITED” U2 Total Knee System (K051640) 2. “UNITED” U2 XPE Total Knee System (K103733) 3. “UNITED” U2 Femoral… | 2006 |
| * | K103733 | United U2 Xpe Total Knee SystemSummary page 4…roduct Code JWH Predicate Device 1. “UNITED” U2 Total Knee System (K051640) 2. “UNITED” U2 XPE Total Knee System (K103733) 3. “UNITED” U2 Femoral Component, PS, #7 (K120507) 4. “UNITED” Tibial… | 2011 |
| * | K120507 | United U2 Femoral Component, PS, #7Summary page 4…Knee System (K051640) 2. “UNITED” U2 XPE Total Knee System (K103733) 3. “UNITED” U2 Femoral Component, PS, #7 (K120507) 4. “UNITED” Tibial inserts, #7 (K131864) 5. “UNITED” Ultracongruent In… | 2012 |
| * | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentSummary page 4…Total Knee System (K103733) 3. “UNITED” U2 Femoral Component, PS, #7 (K120507) 4. “UNITED” Tibial inserts, #7 (K131864) 5. “UNITED” Ultracongruent Insert (K132752) 6. “UNITED” U2 Femoral Com… | 2014 |
| * | K132752 | Ultracongruent InsertSummary page 4…Femoral Component, PS, #7 (K120507) 4. “UNITED” Tibial inserts, #7 (K131864) 5. “UNITED” Ultracongruent Insert (K132752) 6. “UNITED” U2 Femoral Component, CR, Cemented (K140073) Devic… | 2014 |
| * | K140073 | U2 Femoral Component, CR, CementedSummary page 4…5. “UNITED” Ultracongruent Insert (K132752) 6. “UNITED” U2 Femoral Component, CR, Cemented (K140073) Device Description: This subjected device includes femoral component, tibial insert, XPE tibial insert and UOC-FDA-034… | 2014 |
What descends from it? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 29 of the 42 ancestors have a recall of any class.
- Of its descendants, K161705 (United Orthopedic Corporation, 2017) has gone furthest, with 1 descendant 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. 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?
The U2 Total Knee system 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…
Read the full statement (113 words)
The U2 Total Knee system 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 a single use implant and intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150829 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150829: U2 Total Knee System- Additional Sizes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150829
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