Cleared Special

K052631 - SUPER QUICKANCHOR PLUS (WITH ORTHOCORD ...

K052631 is the FDA 510(k) clearance for SUPER QUICKANCHOR PLUS (WITH ORTHOCORD ... 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 25-day FDA review.

K052631 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
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Oct 2005
Decision
25d
Days
Class 2
Risk

K052631 is an FDA 510(k) clearance for the SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE). Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Norwood, US). The FDA issued a Cleared decision on October 21, 2005 after a review of 25 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 K052631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date October 21, 2005
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
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 K052631.
BIOPRO MEMORY STAPLE
K061798 · Biopro, Inc. · Aug 2006
MEMORY STAPLE
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
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
K051989 · Depuy Mitek, A Johnson & Johnson Company · Aug 2005
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · Wrightmedicaltechnologyinc · Jan 2005
ARTHROTEK MENISCAL HYBRID DEVICE
K041988 · Biomet, Inc. · Oct 2004