Cleared Traditional

K922167 - ALPHATEC COMPRESSION AND RECONSTRUCTION...

K922167 is an FDA 510(k) clearance for ALPHATEC COMPRESSION AND RECONSTRUCTION..., manufactured by Alphatec Mfg., Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K922167 · Alphatec Mfg., Inc. · Orthopedic device
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Aug 1992
Decision
90d
Days
Class 2
Risk

K922167 is an FDA 510(k) clearance for the ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Palm Desert, US). The FDA issued a Cleared decision on August 6, 1992 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 888.3030 - 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 - K922167

510(k) Number K922167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1992
Decision Date August 06, 1992
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.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1042
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K922167.
ANSPACH MINI-PLATING SYSTEM
K921338 · The Anspach Effort, Inc. · Feb 1993
RECONSTRUCTION PLATE SYSTEM
K924085 · Sofamor Danek Mfg., Inc. · Dec 1992
DALL MILES BROAD BONE PLATE
K922525 · Howmedica Corp. · Sep 1992
TMP MICROPLATING SYSTEM
K921458 · Techmedica, Inc. · Jul 1992
ALPHATEC COMPRESSION HIP SCREW SYSTEM
K921622 · Alphatec Mfg., Inc. · Jul 1992
RADIUS OSTEOTOMY PLATES
K914804 · Link America, Inc. · Apr 1992