Cleared Traditional

K001507 - MICROPERFORATION INSTRUMENT

K001507 is the FDA 510(k) clearance for MICROPERFORATION INSTRUMENT by Smith & Nephew, Inc.. It is a Class 1 Orthopedic device (product code LXH) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K001507 · Smith & Nephew, Inc. · Orthopedic device
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Jun 2000
Decision
30d
Days
Class 1
Risk

K001507 is an FDA 510(k) clearance for the MICROPERFORATION INSTRUMENT. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on June 14, 2000 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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. devices

Submission Details

510(k) Number K001507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2000
Decision Date June 14, 2000
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXH Orthopedic Manual Surgical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LXH Orthopedic Manual Surgical Instrument

All 22
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K001507.
SX-One MicroKnife
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K952495 · Orthopedic Systems, Inc. · Jan 1996
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
K943873 · Orthomet, Inc. · Apr 1995
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR
K941896 · Depuy, Inc. · Nov 1994
HYPERFLEX FLEXIBLE GUIDEWIRES
K941711 · Linvatec Corp. · Aug 1994
STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
K941605 · Stryker Corp. · Aug 1994