Cleared Traditional

K181338 - Imboki Knee Instrument System

K181338 is an FDA 510(k) clearance for Imboki Knee Instrument System, manufactured by Signature Orthopaedics Pty, Ltd.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K181338 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2019
Decision
241d
Days
Class 2
Risk

K181338 is an FDA 510(k) clearance for the Imboki Knee Instrument System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on January 17, 2019 after a review of 241 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 Signature Orthopaedics Pty, Ltd. devices

FDA 510(k) Submission Details - K181338

510(k) Number K181338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2018
Decision Date January 17, 2019
Days to Decision 241 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
119d slower than avg
Panel avg: 122d · This submission: 241d
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

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