Cleared Traditional

K914004 - ALPHATEC CANNULATED BONE SCREWS

K914004 is an FDA 510(k) clearance for ALPHATEC CANNULATED BONE SCREWS, 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 90-day FDA review.

K914004 · Alphatec Mfg., Inc. · Orthopedic device
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Dec 1991
Decision
90d
Days
Class 2
Risk

K914004 is an FDA 510(k) clearance for the ALPHATEC CANNULATED BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Concord, US). The FDA issued a Cleared decision on December 5, 1991 after a review of 90 days - within the typical 510(k) review window.

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: 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 Alphatec Mfg., Inc. devices

FDA 510(k) Submission Details - K914004

510(k) Number K914004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date December 05, 1991
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K914004.
M. KUROSAKA(TM) FIXATION SCREW
K913210 · Depuy, Inc. · Jan 1992
OREGON FIXATION SCREW
K910976 · Acu Med, Inc. · Jan 1992
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
K915187 · Techmedica, Inc. · Dec 1991
ACE CORTICAL BONE SCREW
K912598 · Ace Medical Co. · Nov 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
K912021 · Instrument Makar, Inc. · Nov 1991
AESCULAP TITANIUM BONE SCREWS
K913415 · Aesculap, Inc. · Oct 1991