Cleared Traditional

K192507 - LOSPA II Knee System

K192507 is an FDA 510(k) clearance for LOSPA II 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 90-day FDA review.

K192507 · Corentec Co., Ltd. · Orthopedic device
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Dec 2019
Decision
90d
Days
Class 2
Risk

K192507 is an FDA 510(k) clearance for the LOSPA II 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, KR). The FDA issued a Cleared decision on December 11, 2019 after a review of 90 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 Corentec Co., Ltd. devices

FDA 510(k) Submission Details - K192507

510(k) Number K192507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2019
Decision Date December 11, 2019
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 885
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K192507.
Physica LMC Knee System
K193284 · Lima Corporate S.P.A. · Jan 2020
ATTUNE All-Polyethylene Tibia
K193057 · Depuy Ireland UC · Jan 2020
Persona Personalized Knee System
K193223 · Zimmer, Inc. · Jan 2020
World Knee Total Knee Systems
K190577 · Signature Orthopaedics Pty, Ltd. · Nov 2019
Physica KR Liner and SMR Reverse Humeral Liner
K190911 · Limacorporate · Nov 2019
PFC SIGMA Knee System
K182301 · DePuy Orthopaedics, Inc. · Nov 2019