Cleared Traditional

K181146 - ASK System

K181146 is the FDA 510(k) clearance for ASK System by L and K Biomed Corporation Limited. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K181146 · L and K Biomed Corporation Limited · Orthopedic device
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Aug 2018
Decision
94d
Days
Class 2
Risk

K181146 is an FDA 510(k) clearance for the ASK System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by L and K Biomed Corporation Limited (Yangcheon-Gu, KR). The FDA issued a Cleared decision on August 3, 2018 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 L and K Biomed Corporation Limited devices

Submission Details

510(k) Number K181146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2018
Decision Date August 03, 2018
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 781
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K181146.
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