510(k) Report

510(k) · Cleared

Cleared

Progressive Orthopaedic Total Knee System

K150783510(k) TraditionalCleared Jun 23, 201590-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

The Progressive Orthopaedic Company, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 23, 2015 as substantially equivalent to K142649 (The Progressive Orthopaedic Company, LLC, 2015) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 2002. 8 later devices descend from it.

Decided
Jun 23, 2015
Review
90 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K021657 (2002). 5 ancestors in all. 8 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2019: 3 descendants cleared2021: 1 descendant cleared2018: 3 descendants cleared2023: 1 descendant clearedK021657 · Uknee Total Knee System · United Orthopedic Corp. · 2002K051640 · U2 Total Knee System · United Orthopedic Corp. · 2006 · recalledK123339 · TK1 Total Knee System · Novosource, Inc. · 2013K131398 · Novoknee Total Knee System · Novosource, Inc. · 2013200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 3 descendants K131398 · Novoknee Total Knee System · Novosource, Inc. · 2013K123339 · TK1 Total Knee System · Novosource, Inc. · 2013K051640 · U2 Total Knee System · United Orthopedic Corp. · 2006 · recalledK021657 · Uknee Total Knee System · United Orthopedic Corp. · 20020
  1. Root · 4 generations backK021657 Uknee Total Knee SystemUnited Orthopedic Corp. · 2002
  2. 3 generations backK051640 U2 Total Knee SystemUnited Orthopedic Corp. · 2006 · Recalled
  3. 2 generations backK123339 TK1 Total Knee SystemNovosource, Inc. · 2013
  4. 1 generation backK131398 Novoknee Total Knee SystemNovosource, Inc. · 2013
  5. This deviceK150783 Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC · 2015
  6. Descendant · cites it directly · 3 of its ownK170753 Acculoc Total Knee SystemRootloc Co., Ltd. · 2018
  7. Descendant · 2 generations on · 0 of its ownK231975 PNK Total Knee SystemTjc Life Co., Ltd. · 2023
  8. Descendant · cites it directly · 0 of its ownK210695 CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC · 2021
  9. Descendant · cites it directly · 0 of its ownK190355 Precision Casting Solutions Total Knee SystemPrecision Casting Solutions, Inc. · 2019
  10. Descendant · cites it directly · 0 of its ownK183344 The Progressive Orthopaedic Company Total Knee System IIThe Progressive Orthopaedic Company, LLC · 2019

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2018: 32019: 32021: 12023: 1
2018high 3 (2018) · low 0 (2020)2026

Most influential descendants

Showing 5 of 8 · See all
  • K170753Acculoc Total Knee SystemRootloc Co., Ltd. · 2018 · cites it directly3descendants
  • K231975PNK Total Knee SystemTjc Life Co., Ltd. · 2023 · 2 generations on0descendants
  • K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC · 2021 · cites it directly0descendants
  • K190355Precision Casting Solutions Total Knee SystemPrecision Casting Solutions, Inc. · 2019 · cites it directly0descendants
  • K183344The Progressive Orthopaedic Company Total Knee System IIThe Progressive Orthopaedic Company, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K021657Uknee Total Knee SystemUnited Orthopedic Corp.2002—
−3K051640U2 Total Knee SystemUnited Orthopedic Corp.20061
−2K123339TK1 Total Knee SystemNovosource, Inc.2013—
−1K131398Novoknee Total Knee SystemNovosource, Inc.2013—
0 (this device)K150783Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC2015—
+1K170753Acculoc Total Knee SystemRootloc Co., Ltd.2018—
+2K231975PNK Total Knee SystemTjc Life Co., Ltd.2023—
+1K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC2021—
+1K190355Precision Casting Solutions Total Knee SystemPrecision Casting Solutions, Inc.2019—
+1K183344The Progressive Orthopaedic Company Total Knee System IIThe Progressive Orthopaedic Company, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201830
201930
202110
202310
FIG. 1 — Lineage of K150783, 2002–2023Source: 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
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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
*K142649Progressive Orthopedic Total Knee System
Summary page 4
…lls under the Orthopedics panel/87 as a Class II device. Device Product Code: JWH Predicate Device: Progressive Orthopaedic Total Knee System (K142649) NovoKnee Total Knee System (K131398) Device Description: The present 510k submission is for a…
The Progressive Orthopaedic Company, LLC2015—
*K131398Novoknee Total Knee System
Summary page 4
…uct Code: JWH Predicate Device: Progressive Orthopaedic Total Knee System (K142649) NovoKnee Total Knee System (K131398) Device Description: The present 510k submission is for a cruciate retaining (CR) version of the Progressive Orthopaedic Total…
Novosource, Inc.2013—

Also cleared against K142649: 7 other devices →

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183
K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC20210
K190355Precision Casting Solutions Total Knee SystemPrecision Casting Solutions, Inc.20190
K183344The Progressive Orthopaedic Company Total Knee System IIThe Progressive Orthopaedic Company, LLC20190
K183225Stabil Orthopaedic Solutions Total Knee SystemStabil Orthopaedic Solutions, LLC20190

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 13 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K170753 (Rootloc Co., Ltd., 2018) has gone furthest, with 3 descendants of its own.
  • 7 other devices also cite its predicate K142649.

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. 2015, 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?

The Progressive Orthopaedic Total Knee System 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 (117 words)

The Progressive Orthopaedic Total Knee System 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.

The Progressive Orthopaedic Total Knee System 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. The Progressive Orthopaedic Total Knee System is designed for cemented use only.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K150783: Progressive Orthopaedic 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/K150783

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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