510(k) · Cleared
ClearedTibial baseplate, Tibial insert
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 Oct 6, 2022 as substantially equivalent to K131864 (United Orthopedic Corporation, 2014) and 5 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Oct 6, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K915132 (1992). 44 ancestors in all, the oldest P830055 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 7 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- 6 generations backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
- 5 generations backK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
- 4 generations backK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
- 3 generations backK131864 U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
- 2 generations backK150829 U2 Total Knee System- Additional SizesUnited Orthopedic Corporation · 2015
- 1 generation backK161705 U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017
- This deviceK222700 Tibial baseplate, Tibial insertUnited Orthopedic Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −7 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| −6 | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | 1 |
| −5 | K093293 | Vanguard 360 Revision Knee System | Biomet, Inc. | 2010 | 5 |
| −4 | K122183 | Augment and Screw, Psa Type | United Orthopedic Corp. | 2013 | — |
| −3 | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | United Orthopedic Corporation | 2014 | — |
| −2 | K150829 | U2 Total Knee System- Additional Sizes | United Orthopedic Corporation | 2015 | — |
| −1 | K161705 | U2 Total Knee System E-XPE products | United Orthopedic Corporation | 2017 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentSummary page 4…d cemented prosthesis per 21CFR 888.3560. This falls under the Orthopedics panel. Predicate devices Predicate 510(k) Number Manufacturer 1. U2 Tibial baseplate, CMA . K131864 United 2. Tibial insert, CR and PS type 2. K051640, K150829, K131864 | Orthopedic 3. XPE Tibial insert, CR and PS type 3. K1037… | 2014 |
| * | K051640 | U2 Total Knee SystemSummary page 4…s under the Orthopedics panel. Predicate devices Predicate 510(k) Number Manufacturer 1. U2 Tibial baseplate, CMA . K131864 United 2. Tibial insert, CR and PS type 2. K051640, K150829, K131864 | Orthopedic 3. XPE Tibial insert, CR and PS type 3. K103733,K150829, K131864 | Corporation UOC-FDA-061 Page:… | 2006 |
| * | K150829 | U2 Total Knee System- Additional SizesSummary page 4…he Orthopedics panel. Predicate devices Predicate 510(k) Number Manufacturer 1. U2 Tibial baseplate, CMA . K131864 United 2. Tibial insert, CR and PS type 2. K051640, K150829, K131864 | Orthopedic 3. XPE Tibial insert, CR and PS type 3. K103733,K150829, K131864 | Corporation UOC-FDA-061 Page: 9 === P… | 2015 |
| * | K103733 | United U2 Xpe Total Knee SystemSummary page 4…acturer 1. U2 Tibial baseplate, CMA . K131864 United 2. Tibial insert, CR and PS type 2. K051640, K150829, K131864 | Orthopedic 3. XPE Tibial insert, CR and PS type 3. K103733,K150829, K131864 | Corporation UOC-FDA-061 Page: 9 K222700 Page 2 of 4 @ U2 Total Knee System #0 Special 510 (k… | 2011 |
| * | K132752 | Ultracongruent InsertSummary page 5…3733,K150829, K131864 | Corporation UOC-FDA-061 Page: 9 K222700 Page 2 of 4 @ U2 Total Knee System #0 Special 510 (k) 4. XPE Tibial insert, UC type 4. K132752,K150829 5. E-XPE Tibial insert, CR and UC and PS type 5. Kl161705 Device description | The U2 Total Knee System consists of Femo… | 2014 |
| * | K161705 | U2 Total Knee System E-XPE productsSummary page 5…al insert, #0 (Subject device) is a size extension of the cleared “UNITED” U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The materials, indications, sterilization of this subject are identical to the cleared “UNITED” U2 Total Knee System, Tibial in… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 29 of the 44 ancestors have a recall of any class.
- 3 other devices also cite its predicate K131864.
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. 2022, 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 Tibial baseplate, CMA, #0 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…
Read the full statement (230 words)
For Tibial baseplate, CMA, #0
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 joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. 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. This device system is designed for cemented use only.
For Tibial insert, #0
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.
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/K222700 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222700: Tibial baseplate, Tibial insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222700
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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