Cleared Traditional

HyProCure II (K142534) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142534 · Graham Medical Technologies, LLC Dba Gramedica · Orthopedic device
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Oct 2014
Decision
24d
Days
Class 2
Risk

K142534 is an FDA 510(k) clearance for the HyProCure II. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Graham Medical Technologies, LLC Dba Gramedica (Macomb, US). The FDA issued a Cleared decision on October 3, 2014 after a review of 24 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 Graham Medical Technologies, LLC Dba Gramedica devices

Submission Details

510(k) Number K142534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2014
Decision Date October 03, 2014
Days to Decision 24 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 401
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K142534.
Arthrex Low Profile Screws
K143614 · Arthrex, Inc. · Jan 2015
PhaLinx Hammertoe System
K142585 · Wrightmedicaltechnologyinc · Nov 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · Zimmer, Inc. · Oct 2014
BIOMET CANNULATED SCREW SYSTEM
K140891 · Biomet, Inc. · Jun 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
K133662 · Smith & Nephew, Inc. · May 2014
SALVATION BEAMS AND BOLTS SYSTEM
K140741 · Wrightmedicaltechnologyinc · May 2014