# K170753: Acculoc Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Rootloc Co., Ltd.
- Decided: Mar 23, 2018 after 375 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K870730 (1987). 21 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051640: U2 Total Knee System, United Orthopedic Corp. (2006) Summary page 4.
- K142649: Progressive Orthopedic Total Knee System, The Progressive Orthopaedic Company, LLC (2015) Summary page 4.
- K150783: Progressive Orthopaedic Total Knee System, The Progressive Orthopaedic Company, LLC (2015) Summary page 4.
- K110404: Eaum Total Knee System, Corentec Co., Ltd. (2012) Summary page 4.
- K123339: TK1 Total Knee System, Novosource, Inc. (2013) Summary page 4.

## Most influential descendants
- K231975: PNK Total Knee System (2023), 0 descendants of its own
- K182370: Acculoc Total Knee System (2018), 0 descendants of its own
- K181146: ASK System (2018), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K170753
Methodology: https://510kreport.com/methodology