510(k) Report

510(k) · Cleared

Cleared

U2 Total Knee System, PSA Tibial Insert

K161360510(k) TraditionalCleared Feb 1, 2017261-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

United Orthopedic Corporation · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 1, 2017 as substantially equivalent to K082424 (United Orthopedic Corp., 2008) and 1 other predicate after a 261-day review. Its family tree reaches back 3 generations to 2002.

Decided
Feb 1, 2017
Review
261 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K021657 (2002). 13 ancestors in all, the oldest K933785 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2007: 2 other ancestors2005: 2 other ancestors2001: 2 other ancestors1996: 1 other ancestor2003: 1 other ancestor1995: 1 other ancestorK021657 · Uknee Total Knee System · United Orthopedic Corp. · 2002K051640 · U2 Total Knee System · United Orthopedic Corp. · 2006 · recalledK082424 · United U2 Total Knee System · United Orthopedic Corp. · 2008 · recalled19952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 4 other ancestors K082424 · United U2 Total Knee System · United Orthopedic Corp. · 2008 · recalledK051640 · U2 Total Knee System · United Orthopedic Corp. · 2006 · recalledK021657 · Uknee Total Knee System · United Orthopedic Corp. · 20020
  1. Root · 3 generations backK021657 Uknee Total Knee SystemUnited Orthopedic Corp. · 2002
  2. 2 generations backK051640 U2 Total Knee SystemUnited Orthopedic Corp. · 2006 · Recalled
  3. 1 generation backK082424 United U2 Total Knee SystemUnited Orthopedic Corp. · 2008 · Recalled
  4. This deviceK161360 U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K021657Uknee Total Knee SystemUnited Orthopedic Corp.2002—
−2K051640U2 Total Knee SystemUnited Orthopedic Corp.20061
−1K082424United U2 Total Knee SystemUnited Orthopedic Corp.20082
0 (this device)K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
200120
200310
200520
200720
201110
FIG. 1 — Lineage of K161360, 2002–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K082424United U2 Total Knee System
Summary page 4
…evice Class Class II Classification Panel Orthopaedics Product Code JWH Predicate Device 1. “UNITED” U2 Total Knee System – PSA Type (K082424) 2. “UNITED” U2 XPE Total Knee System (K103733) Device Description: U2 Total Knee System – PSA Tibial…
United Orthopedic Corp.20082
*K103733United U2 Xpe Total Knee System
Summary page 4
…roduct Code JWH Predicate Device 1. “UNITED” U2 Total Knee System – PSA Type (K082424) 2. “UNITED” U2 XPE Total Knee System (K103733) Device Description: U2 Total Knee System – PSA Tibial Insert is an extended design of U2 Total Knee System – PSA Type (K082424…
United Orthopedic Corporation20112

Also cleared against K082424: 8 other devices →

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 15 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • 9 of the 13 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K082424.

How does its category compare?

All JWH devices

JWH 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

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

This device is indicated in knee arthroplasty 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…

Read the full statement (120 words)

This device is indicated in knee arthroplasty 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 increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.

Note: In the US, this device is for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K082424

8 other devices cite the same predicate.

  • K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation · 2025
  • K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC · 2021
  • K190100USTAR II SystemUnited Orthopedic Corporation · 20195 recalls
  • K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation · 2017
  • K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation · 2014
  • K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation · 2013

More from United Orthopedic Corporation

41 FDA decisions under this applicant name. See the company

  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation · 2025
  • K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
  • K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025
  • K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K161360 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161360: U2 Total Knee System, PSA Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161360

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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