Cleared Traditional

K042030 - HYPROCURE SUBTALAR IMPLANT SYSTEM

K042030 is an FDA 510(k) clearance for HYPROCURE SUBTALAR IMPLANT SYSTEM, manufactured by Graham Medical Technologies, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K042030 · Graham Medical Technologies, LLC · Orthopedic device
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Sep 2004
Decision
50d
Days
Class 2
Risk

K042030 is an FDA 510(k) clearance for the HYPROCURE SUBTALAR IMPLANT SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Graham Medical Technologies, LLC (Shelby Township, US). The FDA issued a Cleared decision on September 16, 2004 after a review of 50 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.

FDA 510(k) Submission Details - K042030

510(k) Number K042030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2004
Decision Date September 16, 2004
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 1058
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K042030.
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
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SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
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ENDOTINE MIDFACE B 4.5 DEVICE
K041835 · Coapt Systems, Inc. · Sep 2004
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
K042244 · Triage Medical, Inc. · Sep 2004
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
K042295 · Linvatec Biomaterials, Ltd. · Sep 2004
ORTHO-PRO CANNULATED BONE SCREWS
K042310 · Ortho-Pro, LLC · Sep 2004
K042030 · HYPROCURE SUBTALAR IMPLANT SYSTEM
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