510(k) · Cleared
ClearedThe Progressive Orthopaedic Company Total Knee System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Progressive Orthopaedic Company, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 18, 2019 as substantially equivalent to K142649 (The Progressive Orthopaedic Company, LLC, 2015) and 1 other predicate after a 105-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Mar 18, 2019
- Review
- 105 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K021657 (2002). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK021657 Uknee Total Knee SystemUnited Orthopedic Corp. · 2002
- 4 generations backK051640 U2 Total Knee SystemUnited Orthopedic Corp. · 2006 · Recalled
- 3 generations backK123339 TK1 Total Knee SystemNovosource, Inc. · 2013
- 2 generations backK131398 Novoknee Total Knee SystemNovosource, Inc. · 2013
- 1 generation backK150783 Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC · 2015
- This deviceK183344 The Progressive Orthopaedic Company Total Knee System IIThe Progressive Orthopaedic Company, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K021657 | Uknee Total Knee System | United Orthopedic Corp. | 2002 | — |
| −4 | K051640 | U2 Total Knee System | United Orthopedic Corp. | 2006 | 1 |
| −3 | K123339 | TK1 Total Knee System | Novosource, Inc. | 2013 | — |
| −2 | K131398 | Novoknee Total Knee System | Novosource, Inc. | 2013 | — |
| −1 | K150783 | Progressive Orthopaedic Total Knee System | The Progressive Orthopaedic Company, LLC | 2015 | — |
| 0 (this device) | K183344 | The Progressive Orthopaedic Company Total Knee System II | The Progressive Orthopaedic Company, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K142649 | Progressive Orthopedic Total Knee SystemSummary page 4…Legally Marketed Predicate The Progressive Orthopaedic Company Total Knee System II is utilizing the Progressive Orthopaedic Total Knee System as the predicate device (K142649/K150783). The Progressive Orthopaedic Company Total Knee System II features component designs, materials, indications, and manufa… | 2015 |
| * | K150783 | Progressive Orthopaedic Total Knee SystemSummary page 4…y Marketed Predicate The Progressive Orthopaedic Company Total Knee System II is utilizing the Progressive Orthopaedic Total Knee System as the predicate device (K142649/K150783). The Progressive Orthopaedic Company Total Knee System II features component designs, materials, indications, and manufacturing… | 2015 |
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 17 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 7 other devices also cite its predicate K142649.
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. 2019, 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?
The Progressive Orthopaedic Company Total Knee System II 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…
Read the full statement (123 words)
The Progressive Orthopaedic Company Total Knee System II 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 Company Total Knee System II 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 Company Total Knee System II is designed 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/K183344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183344: The Progressive Orthopaedic Company Total Knee System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183344
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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