Cleared Traditional

K921622 - ALPHATEC COMPRESSION HIP SCREW SYSTEM

K921622 is an FDA 510(k) clearance for ALPHATEC COMPRESSION HIP SCREW SYSTEM, 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 87-day FDA review.

K921622 · Alphatec Mfg., Inc. · Orthopedic device
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Jul 1992
Decision
87d
Days
Class 2
Risk

K921622 is an FDA 510(k) clearance for the ALPHATEC COMPRESSION HIP SCREW SYSTEM. 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 July 2, 1992 after a review of 87 days - a notably fast clearance cycle.

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: 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 - K921622

510(k) Number K921622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date July 02, 1992
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K921622.
DALL MILES BROAD BONE PLATE
K922525 · Howmedica Corp. · Sep 1992
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K922167 · Alphatec Mfg., Inc. · Aug 1992
TMP MICROPLATING SYSTEM
K921458 · Techmedica, Inc. · Jul 1992
RADIUS OSTEOTOMY PLATES
K914804 · Link America, Inc. · Apr 1992
SCHWABE RADIUS PLATES
K914803 · Link America, Inc. · Apr 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818 · Synthes (Usa) · Jan 1992