Cleared Traditional

K921402 - SURGICAL INSTRUMENT, DISPOSABLE

K921402 is an FDA 510(k) clearance for SURGICAL INSTRUMENT, manufactured by Macro Medical, Inc.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K921402 · Macro Medical, Inc. · Orthopedic device
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Jun 1992
Decision
72d
Days
Class 1
Risk

K921402 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT, DISPOSABLE. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Macro Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 4, 1992 after a review of 72 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.

FDA 510(k) Submission Details - K921402

510(k) Number K921402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date June 04, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
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 34
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K921402.
BARRIER BONE WAX APPLICATOR
K934260 · Phillips Pharmaceuticals, Inc. · Jan 1994
BIO-PREP
K931846 · Biomedical Devices, Inc. · Jan 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
T-HANDLE HEX WRENCH
K903270 · Onyx Medical Corp. · Jul 1990