510(k) · Cleared
ClearedU2 Total Knee System-PF+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Feb 28, 2023 as substantially equivalent to K140075 (United Orthopedic Corp., 2014) and 1 other predicate after a 260-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Feb 28, 2023
- Review
- 260 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951987 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 3 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 2 generations backK140075 U2 Femoral Component, CR, Porous CoatedUnited Orthopedic Corp. · 2014
- 1 generation backK150832 U2 Femoral Component, CR, Porous Coated, Additional SizesUnited Orthopedic Corporation · 2015
- This deviceK221705 U2 Total Knee System-PF+United Orthopedic Corporation · 2023
- Descendant · cites it directly · 0 of its ownK243656 U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −3 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −2 | K140075 | U2 Femoral Component, CR, Porous Coated | United Orthopedic Corp. | 2014 | — |
| −1 | K150832 | U2 Femoral Component, CR, Porous Coated, Additional Sizes | United Orthopedic Corporation | 2015 | — |
| 0 (this device) | K221705 | U2 Total Knee System-PF+ | United Orthopedic Corporation | 2023 | — |
| +1 | K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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 |
|---|---|---|---|
| * | K140075 | U2 Femoral Component, CR, Porous CoatedSummary page 4…ate Product name Manufacturer 510(k) Number U2 Femoral Component, CR, Porous United Orthopedic Corporation K140075, K150832 Coated Predicate or Reference Device U2 Total Knee System United Orthopedic Corporation K0516… | 2014 |
| * | K150832 | U2 Femoral Component, CR, Porous Coated, Additional SizesSummary page 4…uct name Manufacturer 510(k) Number U2 Femoral Component, CR, Porous United Orthopedic Corporation K140075, K150832 Coated Predicate or Reference Device U2 Total Knee System United Orthopedic Corporation K051640, K1205… | 2015 |
| † | K051640 | U2 Total Knee System | 2006 |
| † | K120507 | United U2 Femoral Component, PS, #7 | 2012 |
| † | K181794 | Truliant Porous Femoral Components | 2018 |
| † | K123486 | Triathlon Tritanium Tibial Baseplate | 2013 |
| † | K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | 2016 |
| † | K140942 | Klassic Knee Tibial Stem Extension | 2014 |
| † | K190100 | USTAR II System | 2019 |
| † | K151316 | U2 Hip Stem, Ti Porous Coated, Matrix | 2015 |
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 |
|---|---|---|---|
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | 2025 | 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 28 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K243656 (United Orthopedic Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140075.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
U2 Total Knee System - PF+ 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 (124 words)
U2 Total Knee System - PF+ 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 joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Femoral Component, PF+, Tibial Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and cementless use.
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/K221705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221705: U2 Total Knee System-PF+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221705
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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