Cleared Special

K023417 - SURETAC III, MODELS 7209900, 7209901

K023417 is an FDA 510(k) clearance for SURETAC III, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Special 510(k) pathway after a 27-day FDA review.

K023417 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
27d
Days
Class 2
Risk

K023417 is an FDA 510(k) clearance for the SURETAC III, MODELS 7209900, 7209901. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on November 7, 2002 after a review of 27 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.

FDA 510(k) Submission Details - K023417

510(k) Number K023417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2002
Decision Date November 07, 2002
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 232
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K023417.
ORTHOPEDIC WIRE
K031127 · Howmedica Osteonics Corp. · Apr 2003
MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
K023388 · Mitek Worldwide · Dec 2002
MITEK PDS/PGA STAPLE
K021953 · Mitek Worldwide · Dec 2002
OSSTAPLE
K023203 · Biomedical Ent., Inc. · Oct 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · Smith & Nephew, Inc. · Oct 2002
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · Medtronic Sofamor Danek, Inc. · Oct 2001
K023417 · SURETAC III, MODELS 7209900, 7209901
Download PDF FDA Summary Smith & Nephew, Inc.