Cleared Traditional

K142534 - HyProCure II

K142534 is an FDA 510(k) clearance for HyProCure II, manufactured by Graham Medical Technologies, LLC Dba Gramedica. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K142534 · Graham Medical Technologies, LLC Dba Gramedica · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K142534

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Secure BioMed Evaluations
LINDA BRADDON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1042
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K142534.
J-SCREW COMPRESSION SCREW
K130019 · Competitive Engineering, Inc. · Nov 2014
Biomet Headless Compression and Twist-off Screws
K142658 · Biomet Manufacturing Corp · Nov 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · Zimmer, Inc. · Oct 2014
HELICAL RIDGE PEEK INTERFERENCE SCREW
K141290 · MedShape, Inc. · Sep 2014
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
K141949 · Aap Implantate AG · Sep 2014
TRIDENT FUSION IMPLANT
K141937 · Vilex IN Tennessee, Inc. · Sep 2014