Cleared Special

K063273 - PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR

K063273 is an FDA 510(k) clearance for PANALOK QUICKANCHOR PLUS, manufactured by Depuy Miltek, A Johnson & Johnson Co.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Special 510(k) pathway after a 23-day FDA review.

K063273 · Depuy Miltek, A Johnson & Johnson Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
23d
Days
Class 2
Risk

K063273 is an FDA 510(k) clearance for the PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK AN.... Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Depuy Miltek, A Johnson & Johnson Co. (Raynham, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 23 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 Miltek, A Johnson & Johnson Co. devices

FDA 510(k) Submission Details - K063273

510(k) Number K063273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2006
Decision Date November 22, 2006
Days to Decision 23 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 K063273.
SBI STAFIX
K071479 · Small Bone Innovations, Inc. · Aug 2007
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
K071257 · Depuy Mitek, A Johnson & Johnson Company · Jun 2007
NEXFIX COMPRESSION STAPLE
K070688 · Nexa Orthopedics, Inc. · May 2007
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
K061776 · Arthrotek, Inc. · Sep 2006
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170 · Depuy Mitek, A Johnson & Johnson Company · Aug 2006
BIOPRO MEMORY STAPLE
K061798 · Biopro, Inc. · Aug 2006