Cleared Traditional

K160157 - LOSPA Modular Knee System

K160157 is an FDA 510(k) clearance for LOSPA Modular Knee System, manufactured by Corentec Co., Ltd.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K160157 · Corentec Co., Ltd. · Orthopedic device
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Dec 2016
Decision
314d
Days
Class 2
Risk

K160157 is an FDA 510(k) clearance for the LOSPA Modular Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Corentec Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on December 1, 2016 after a review of 314 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 Corentec Co., Ltd. devices

FDA 510(k) Submission Details - K160157

510(k) Number K160157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2016
Decision Date December 01, 2016
Days to Decision 314 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
192d slower than avg
Panel avg: 122d · This submission: 314d
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 889
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K160157.
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PS2 Knee System
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K162422 · Total Joint Orthopedics, Inc. · Oct 2016
EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)
K161945 · Encore Medical, L.P. · Sep 2016