Cleared Traditional

K112727 - MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL

K112727 is an FDA 510(k) clearance for MEDICAL FACETS CORICAL SCREWS, manufactured by Medical Facets. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K112727 · Medical Facets · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
115d
Days
Class 2
Risk

K112727 is an FDA 510(k) clearance for the MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACE.... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medical Facets (Gastonia, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 115 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K112727

510(k) Number K112727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2011
Decision Date January 13, 2012
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 K112727.
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K112240 · U&I Corp. · Jan 2012
COLS PEEK
K113591 · Fournitures Hospitalieres Industrie · Dec 2011
IFS SUBTALAR IMPLANT
K113399 · Internal Fixation Systems, Inc. · Dec 2011
K112727 · MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
Download PDF FDA Summary Medical Facets