Cleared Special

K063273 - PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

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 230
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