510(k) · Cleared
ClearedU2 Total Knee System E-XPE products
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 Mar 16, 2017 as substantially equivalent to K103733 (United Orthopedic Corporation, 2011) and 4 other predicates after a 269-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Mar 16, 2017
- Review
- 269 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K915132 (1992). 43 ancestors in all, the oldest P830055 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 6 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- 5 generations backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
- 4 generations backK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
- 3 generations backK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
- 2 generations backK131864 U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
- 1 generation backK150829 U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015
- This deviceK161705 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
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −7 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −6 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| −5 | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | 1 |
| −4 | K093293 | Vanguard 360 Revision Knee System | Biomet, Inc. | 2010 | 5 |
| −3 | K122183 | Augment and Screw, Psa Type | United Orthopedic Corp. | 2013 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K031640 | U2 Total Knee System- Insert and Patella Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…emorotibial metal/polymer porous-coated uncemented prosthesis.” under 21CFR §888. 3565 Class II Orthopaedics JWH, OIY, MBH 1. U2 Total Knee System- Insert and Patella (K031640, K 103733, K131864, K132752 and K150829), United Orthopedic Corporation. 2. U2 Total Knee System-PSA Type (K082424), United Orth… | |
| * | K103733 | United U2 Xpe Total Knee SystemSummary page 4…al metal/polymer porous-coated uncemented prosthesis.” under 21CFR §888. 3565 Class II Orthopaedics JWH, OIY, MBH 1. U2 Total Knee System- Insert and Patella (K031640, K 103733, K131864, K132752 and K150829), United Orthopedic Corporation. 2. U2 Total Knee System-PSA Type (K082424), United Orthopedic Cor… | 2011 |
| * | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentSummary page 4…olymer porous-coated uncemented prosthesis.” under 21CFR §888. 3565 Class II Orthopaedics JWH, OIY, MBH 1. U2 Total Knee System- Insert and Patella (K031640, K 103733, K131864, K132752 and K150829), United Orthopedic Corporation. 2. U2 Total Knee System-PSA Type (K082424), United Orthopedic Corporation.… | 2014 |
| * | K132752 | Ultracongruent InsertSummary page 4…rous-coated uncemented prosthesis.” under 21CFR §888. 3565 Class II Orthopaedics JWH, OIY, MBH 1. U2 Total Knee System- Insert and Patella (K031640, K 103733, K131864, K132752 and K150829), United Orthopedic Corporation. 2. U2 Total Knee System-PSA Type (K082424), United Orthopedic Corporation. A200 Kn… | 2014 |
| * | K150829 | U2 Total Knee System- Additional SizesSummary page 4…uncemented prosthesis.” under 21CFR §888. 3565 Class II Orthopaedics JWH, OIY, MBH 1. U2 Total Knee System- Insert and Patella (K031640, K 103733, K131864, K132752 and K150829), United Orthopedic Corporation. 2. U2 Total Knee System-PSA Type (K082424), United Orthopedic Corporation. A200 Knee System (K… | 2015 |
| * | K082424 | United U2 Total Knee SystemSummary page 4…IY, MBH 1. U2 Total Knee System- Insert and Patella (K031640, K 103733, K131864, K132752 and K150829), United Orthopedic Corporation. 2. U2 Total Knee System-PSA Type (K082424), United Orthopedic Corporation. A200 Knee System (K120038), Renovis Surgical Technologies. 4, PFC Sigma" Knee System (K943462,… | 2008 |
| † | K120038 | A200 Knee System | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222700 | Tibial baseplate, Tibial insert | 2022 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 29 of the 43 ancestors have a recall of any class.
- Of its descendants, K222700 (United Orthopedic Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K103733.
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. 2017, 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?
For E-XPE Insert (CR, PS and UC type) and Patella: The 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…
Read the full statement (238 words)
For E-XPE Insert (CR, PS and UC type) and Patella:
The 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 a single use implant and intended for cemented use only.
For E-XPE Insert (PSA type)
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. This device is a single use implant and intended for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161705: U2 Total Knee System E-XPE products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161705
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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