Cleared Traditional

K933242 - SOFAMOR ORTHOPAEDIC INSTRUMENTS

K933242 is an FDA 510(k) clearance for SOFAMOR ORTHOPAEDIC INSTRUMENTS, manufactured by Danek Medical, Inc.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K933242 · Danek Medical, Inc. · Orthopedic device
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Jan 1994
Decision
210d
Days
Class 1
Risk

K933242 is an FDA 510(k) clearance for the SOFAMOR ORTHOPAEDIC INSTRUMENTS. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on January 28, 1994 after a review of 210 days - an extended review 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: 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K933242

510(k) Number K933242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1993
Decision Date January 28, 1994
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

LXH Device Classification - Class 1, General Controls

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 23
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K933242.
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
CALMPS: BONE, MASTIN, LEWIN, BRAND
K930028 · Thomasville Medical Assoc. · Feb 1993
ADJUSTABLE ANGLE GUIDE
K903247 · Onyx Medical Corp. · Jul 1990
DRIVER/EXTRACTOR
K903257 · Onyx Medical Corp. · Jul 1990