510(k) · Cleared
Recalled · Class II · 2013United U2 Xpe Total Knee System
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 Aug 2, 2011 as substantially equivalent to K051640 (United Orthopedic Corp., 2006) and 5 other predicates after a 223-day review. Its family tree reaches back 2 generations to 2001. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 2, 2011
- Review
- 223 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 2 generations to K003910 (2001). 10 ancestors in all, the oldest K933785 (1995). 8 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK003910 Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate…Zimmer, Inc. · 2001 · Recalled
- 1 generation backK013991 Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR)…Zimmer, Inc. · 2001
- This deviceK103733 United U2 Xpe Total Knee SystemUnited Orthopedic Corporation · 2011
- Descendant · cites it directly · 5 of its ownK132752 Ultracongruent InsertUnited Orthopedic Corporation · 2014
- Descendant · cites it directly · 5 of its ownK131864 U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
- Descendant · cites it directly · 3 of its ownK150829 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K132752Ultracongruent InsertUnited Orthopedic Corporation · 2014 · cites it directly5descendants
- K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014 · cites it directly5descendants
- K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015 · cites it directly3descendants
- K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017 · cites it directly1descendant
- K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003910 | Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining… | Zimmer, Inc. | 2001 | 65 |
| −1 | K013991 | Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular… | Zimmer, Inc. | 2001 | — |
| 0 (this device) | K103733 | United U2 Xpe Total Knee System | United Orthopedic Corporation | 2011 | — |
| +1 | K132752 | Ultracongruent Insert | United Orthopedic Corporation | 2014 | — |
| +1 | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | United Orthopedic Corporation | 2014 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 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 1…1CFR 888.3560. This falls under the Orthopedics panel. Device Product Code JWH Predicate Device: 1. "UNITED" U2 Total Knee system (K05 1640) 2. "UNITED" UKNEE Total Knee System (K02 1657) 3. -"Zimmer" Prolong Hig… | 2006 |
| * | K021657 | Uknee Total Knee SystemSummary page 1…anel. Device Product Code JWH Predicate Device: 1. "UNITED" U2 Total Knee system (K05 1640) 2. "UNITED" UKNEE Total Knee System (K02 1657) 3. -"Zimmer" Prolong Highly Crosslinked Polyethylene CR Articular Su… | 2002 |
| * | K013991 | Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface…Summary page 1…Knee System (K02 1657) 3. -"Zimmer" Prolong Highly Crosslinked Polyethylene CR Articular Surface Components (K013991) 4. "Howmedica Osteonic" Scorpio X3 Tibial Bearing Insert (K07 1991)… | 2001 |
| * | K071991 | Modification to Scorpio NRG Knee SystemSummary page 1…Articular Surface Components (K013991) 4. "Howmedica Osteonic" Scorpio X3 Tibial Bearing Insert (K07 1991) 5. "Zimmer"NexGen Prolong All-Poly Patella (K07228 1) 6. "Howmedica Osteon… | 2007 |
| * | K072281 | Nexgen Prolong All-Poly PatellaSummary page 1…. "Howmedica Osteonic" Scorpio X3 Tibial Bearing Insert (K07 1991) 5. "Zimmer"NexGen Prolong All-Poly Patella (K07228 1) 6. "Howmedica Osteonics" Scorpio X3 Patellar components (KOS51997)… | 2007 |
| * | K051977 | Scorpio Knee System Tibial Inserts and Patellar Components Our reading of the summary gave K051997, FDA’s number for Capiox RX15 Hollow, Fiber Oxygenator with/Without… (Terumo Cardiovascular Systems Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “"Howmedica Osteonics" Scorpio X3 Patellar components”. | 2005 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132752 | Ultracongruent Insert | 2014 | 5 |
| K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | 2014 | 5 |
| K150829 | U2 Total Knee System- Additional Sizes | 2015 | 3 |
| K161705 | U2 Total Knee System E-XPE products | 2017 | 1 |
| K222700 | Tibial baseplate, Tibial insert | 2022 | 0 |
| K161360 | U2 Total Knee System, PSA Tibial Insert | 2017 | 0 |
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-1379-2013 | 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. |
| Feb 20, 2013 | Class II | Z-1380-2013 | 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 9.6 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K132752 (United Orthopedic Corporation, 2014) has gone furthest, with 5 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. 2011, 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, posttraumnatic loss of joint configuration, particularly when there is patellofemoral erosion…
Read the full statement (109 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, posttraumnatic 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 in the U.S.A.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103733: United U2 Xpe 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/K103733
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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