510(k) · Cleared
ClearedPNK Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tjc Life Co., Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 21, 2023 as substantially equivalent to K170753 (Rootloc Co., Ltd., 2018) and 4 other predicates after a 141-day review. Its family tree reaches back 7 generations to 1987.
- Decided
- Nov 21, 2023
- Review
- 141 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K870730 (1987). 31 ancestors in all, the oldest K863668 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 6 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 5 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 4 generations backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- 3 generations backK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
- 2 generations backK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012
- 1 generation backK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · Recalled
- This deviceK231975 PNK Total Knee SystemTjc Life Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −6 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −5 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −4 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| −3 | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | 2 |
| −2 | K121037 | Lospa Tibial Base Plate | Corentec Co., Ltd. | 2012 | — |
| −1 | K130673 | Lospa Total Knee Replacement System | Corentec Co., Ltd. | 2013 | 2 |
| 0 (this device) | K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (5)
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 |
|---|---|---|---|
| * | K170753 | Acculoc Total Knee SystemSummary page 7…Name Primary Acculoc Total RootLoc Co., Ltd K170753 Predicate Knee System… | 2018 |
| * | K110404 | Eaum Total Knee SystemSummary page 7…ee System EAUM Total K110404 Knee System Corentec Co., Ltd… | 2012 |
| * | K130673 | Lospa Total Knee Replacement SystemSummary page 7…LOSAPA Total Knee K130673 Replacement Secondary… | 2013 |
| * | K170534 | Prolixus Total Knee SystemSummary page 7…System Predicate PROLIXUS OTIS Biotech Co., Ltd Total knee K170534 System The Progressive… | 2017 |
| * | K142649 | Progressive Orthopedic Total Knee SystemSummary page 7…System The Progressive Progressive Orthopedic Company, Orthopedic Total K142649 LLC Knee System TJC Life Co.… | 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 36 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 13 of the 31 ancestors have a recall of any class.
- 2 other devices also cite its predicate K170753.
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. 2023, 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 PNK 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, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be…
Read the full statement (101 words)
The PNK 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, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The PNK Total Knee System is designed for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231975: PNK 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/K231975
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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