Cleared Special

K060553 - RC LOOP /DUAL ORTHOCORD SUTURE

K060553 is the FDA 510(k) clearance for RC LOOP /DUAL ORTHOCORD SUTURE by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (product code JDR) cleared through the Special 510(k) pathway after a 64-day FDA review.

K060553 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
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May 2006
Decision
64d
Days
Class 2
Risk

K060553 is an FDA 510(k) clearance for the RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL S.... Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on May 4, 2006 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Depuy Mitek, A Johnson & Johnson Company devices

Submission Details

510(k) Number K060553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2006
Decision Date May 04, 2006
Days to Decision 64 days
Submission Type Special
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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 97
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K060553.
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170 · Depuy Mitek, A Johnson & Johnson Company · Aug 2006
BIOPRO MEMORY STAPLE
K061798 · Biopro, Inc. · Aug 2006
MEMORY STAPLE
K060746 · DePuy Orthopaedics, Inc. · 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