Cleared Traditional

K063726 - PLC SUTURE ANCHOR

K063726 is an FDA 510(k) clearance for PLC SUTURE ANCHOR, manufactured by Smith & Nephew Inc., Endoscopy Div.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K063726 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
81d
Days
Class 2
Risk

K063726 is an FDA 510(k) clearance for the PLC SUTURE ANCHOR. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on March 6, 2007 after a review of 81 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew Inc., Endoscopy Div. devices

FDA 510(k) Submission Details - K063726

510(k) Number K063726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2006
Decision Date March 06, 2007
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 1006
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K063726.
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K070169 · KLS-Martin L.P. · Mar 2007
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K063875 · Howmedica Osteonics Corp. · Mar 2007
DALL-MILES SYSTEM
K070170 · Stryker Orthopaedics · Mar 2007
LISFRANC PLATE
K063820 · New Deal, S.A. · Feb 2007
MODIFICATION TO TTC PLATES
K070160 · New Deal, S.A. · Feb 2007