Cleared Traditional

ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW (K922322) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922322 · Alphatec Mfg., Inc. · Orthopedic device
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Aug 1992
Decision
79d
Days
Class 2
Risk

K922322 is an FDA 510(k) clearance for the ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Palm Desert, US). The FDA issued a Cleared decision on August 5, 1992 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Alphatec Mfg., Inc. devices

Submission Details

510(k) Number K922322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1992
Decision Date August 05, 1992
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K922322.
ARTHROTEK INTERFERENCE SCREW
K934469 · Biomet, Inc. · Feb 1994
3.5MM UNIVERSAL COMPRESSION SCREW
K923477 · Howmedica Corp. · Mar 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424 · Arthrex, Inc. · Feb 1993
UNIVERSAL COMPRESION SCREW
K915124 · Howmedica Corp. · Feb 1992
M. KUROSAKA(TM) FIXATION SCREW
K913210 · Depuy, Inc. · Jan 1992
AESCULAP TITANIUM BONE SCREWS
K913415 · Aesculap, Inc. · Oct 1991