Cleared Traditional

K170753 - Acculoc Total Knee System

K170753 is an FDA 510(k) clearance for Acculoc Total Knee System, manufactured by Rootloc Co., Ltd.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K170753 · Rootloc Co., Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2018
Decision
375d
Days
Class 2
Risk

K170753 is an FDA 510(k) clearance for the Acculoc Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Rootloc Co., Ltd. (Geumcheon-Gu, KR). The FDA issued a Cleared decision on March 23, 2018 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Rootloc Co., Ltd. devices

FDA 510(k) Submission Details - K170753

510(k) Number K170753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2017
Decision Date March 23, 2018
Days to Decision 375 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 122d · This submission: 375d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 887
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K170753.
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