Cleared Traditional

K060014 - INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS

K060014 is an FDA 510(k) clearance for INTELIFUSE, manufactured by Intelifuse, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K060014 · Intelifuse, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
90d
Days
Class 2
Risk

K060014 is an FDA 510(k) clearance for the INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Intelifuse, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on April 3, 2006 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 888.3030 - 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 Intelifuse, Inc. devices

FDA 510(k) Submission Details - K060014

510(k) Number K060014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2006
Decision Date April 03, 2006
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 160
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K060014.
LARGE UNI-CLIP STAPLE
K061594 · New Deal, S.A. · Jul 2006
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K060746 · DePuy Orthopaedics, Inc. · May 2006
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE
K060553 · Depuy Mitek, A Johnson & Johnson Company · May 2006
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052631 · Depuy Mitek, A Johnson & Johnson Company · Oct 2005
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
K051989 · Depuy Mitek, A Johnson & Johnson Company · Aug 2005
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · Wrightmedicaltechnologyinc · Jan 2005