Cleared Traditional

K922322 - ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW

K922322 is an FDA 510(k) clearance for ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW, manufactured by Alphatec Mfg., Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 79-day FDA review.

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

FDA 510(k) Submission Details - K922322

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 734
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K922322.
ACUFEX FIXATION POST
K924514 · Acufex Microsurgical, Inc. · Oct 1992
ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW
K923256 · Alphatec Mfg., Inc. · Oct 1992
ALPHATEC SMALL FRAGMENT SET
K922166 · Alphatec Mfg., Inc. · Aug 1992
CONCEPT ENDOSTEAL FIXATION DEVICE
K912640 · Concept, Inc. · May 1992
CORTICAL BONE SCREW
K915448 · Dow Corning Wright · Feb 1992
BONE SCREW 3.5 MM
K915613 · Acu Med, Inc. · Feb 1992