Cleared Traditional

K160771 - Destiknee Total Knee System

K160771 is an FDA 510(k) clearance for Destiknee Total Knee System, manufactured by Meril Healthcare Private Limited. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K160771 · Meril Healthcare Private Limited · Orthopedic device
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Dec 2016
Decision
273d
Days
Class 2
Risk

K160771 is an FDA 510(k) clearance for the Destiknee Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Meril Healthcare Private Limited (Vapi, IN). The FDA issued a Cleared decision on December 19, 2016 after a review of 273 days - an extended review cycle.

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 Meril Healthcare Private Limited devices

FDA 510(k) Submission Details - K160771

510(k) Number K160771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2016
Decision Date December 19, 2016
Days to Decision 273 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
151d slower than avg
Panel avg: 122d · This submission: 273d
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 814
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K160771.
Truliant Femoral Components
K170240 · Exactech, Inc. · Feb 2017
U2 Total Knee System, PSA Tibial Insert
K161360 · United Orthopedic Corporation · Feb 2017
Legion Cone System
K162775 · Smith & Nephew, Inc. · Jan 2017
LOSPA Modular Knee System
K160157 · Corentec Co., Ltd. · Dec 2016
Materialise TKA Guide System
K162273 · Materialise NV · Nov 2016
Klassic Knee System
K162422 · Total Joint Orthopedics, Inc. · Oct 2016