510(k) · Cleared
ClearedAcculoc Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rootloc Co., Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 23, 2018 as substantially equivalent to K051640 (United Orthopedic Corp., 2006) and 4 other predicates after a 375-day review. Its family tree reaches back 5 generations to 1987. 3 later devices descend from it.
- Decided
- Mar 23, 2018
- Review
- 375 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K870730 (1987). 21 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 4 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 3 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 2 generations backK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- 1 generation backK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
- This deviceK170753 Acculoc Total Knee SystemRootloc Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK231975 PNK Total Knee SystemTjc Life Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK182370 Acculoc Total Knee SystemRootloc Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK181146 ASK SystemL and K Biomed Corporation Limited · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −4 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −3 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −2 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| −1 | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | 2 |
| 0 (this device) | K170753 | Acculoc Total Knee System | Rootloc Co., Ltd. | 2018 | — |
| +1 | K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | 2023 | — |
| +1 | K182370 | Acculoc Total Knee System | Rootloc Co., Ltd. | 2018 | — |
| +1 | K181146 | ASK System | L and K Biomed Corporation Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K051640 | U2 Total Knee SystemSummary page 4…td. here by submits this traditional 510(k) 4. Predicate or legally marketed devices which are substantially equivalent : United Orthopedic U2 Total Knee System (K051640) Progressive Orthopaedic Total Knee System (K142649, K150783) Corentec EAUM/LOSPA TKR System (K110404) NovoKnee To… | 2006 |
| * | K142649 | Progressive Orthopedic Total Knee SystemSummary page 4…te or legally marketed devices which are substantially equivalent : United Orthopedic U2 Total Knee System (K051640) Progressive Orthopaedic Total Knee System (K142649, K150783) Corentec EAUM/LOSPA TKR System (K110404) NovoKnee Total Knee System (K123339) 5. Description of the Device… | 2015 |
| * | K150783 | Progressive Orthopaedic Total Knee SystemSummary page 4…ally marketed devices which are substantially equivalent : United Orthopedic U2 Total Knee System (K051640) Progressive Orthopaedic Total Knee System (K142649, K150783) Corentec EAUM/LOSPA TKR System (K110404) NovoKnee Total Knee System (K123339) 5. Description of the Device T… | 2015 |
| * | K110404 | Eaum Total Knee SystemSummary page 4…equivalent : United Orthopedic U2 Total Knee System (K051640) Progressive Orthopaedic Total Knee System (K142649, K150783) Corentec EAUM/LOSPA TKR System (K110404) NovoKnee Total Knee System (K123339) 5. Description of the Device The Acculoc Total Knee System is of the fixed b… | 2012 |
| * | K123339 | TK1 Total Knee SystemSummary page 4…al Knee System (K051640) Progressive Orthopaedic Total Knee System (K142649, K150783) Corentec EAUM/LOSPA TKR System (K110404) NovoKnee Total Knee System (K123339) 5. Description of the Device The Acculoc Total Knee System is of the fixed bearing type with a posterior stabil… | 2013 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K231975 (Tjc Life Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K051640.
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. 2018, 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 Acculoc 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 Acculoc 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 Acculoc Total Knee System is designed for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170753: Acculoc 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/K170753
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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