Cleared Traditional

K020948 - SMITH & NEPHEW SURETAC - EXPANDED INDIC...

K020948 is the FDA 510(k) clearance for SMITH & NEPHEW SURETAC - EXPANDED INDIC... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K020948 · Smith & Nephew, Inc. · Orthopedic device
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Oct 2002
Decision
198d
Days
Class 2
Risk

K020948 is an FDA 510(k) clearance for the SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II. 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 October 9, 2002 after a review of 198 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K020948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2002
Decision Date October 09, 2002
Days to Decision 198 days
Submission Type Traditional
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
76d slower than avg
Panel avg: 122d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K020948.
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K041115 · Depuy Mitek, A Johnson & Johnson Company · May 2004
ORTHOPEDIC WIRE
K031127 · Howmedica Osteonics Corp. · Apr 2003
SURETAC III, MODELS 7209900, 7209901
K023417 · Smith & Nephew, Inc. · Nov 2002
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · Medtronic Sofamor Danek, Inc. · Oct 2001
LACTOSORB POP RIVET
K981798 · Biomet, Inc. · Jul 1998
HOWMEDICA MAINSTAY ANCHOR
K965175 · Howmedica Corp. · Mar 1997