Cleared Traditional

LOSPA Modular Knee System (K160157) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 517
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K160157.
GMK Sphere
K162035 · Medacta International S.A. · Mar 2017
Truliant Femoral Components
K170240 · Exactech, Inc. · Feb 2017
Legion Cone System
K162775 · Smith & Nephew, Inc. · Jan 2017
Optetrak Logic Metaphyseal Cones
K153595 · Exactech, Inc. · Mar 2016
Optetrak Advanced Patella
K160484 · Exactech, Inc. · Mar 2016
Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
K152494 · Zimmer, Inc. · Nov 2015