Cleared Traditional

K111908 - BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

K111908 is an FDA 510(k) clearance for BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM, manufactured by Biomet Microfixation, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K111908 · Biomet Microfixation, Inc. · Orthopedic device
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Nov 2011
Decision
147d
Days
Class 2
Risk

K111908 is an FDA 510(k) clearance for the BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet Microfixation, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 29, 2011 after a review of 147 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.

View all Biomet Microfixation, Inc. devices

FDA 510(k) Submission Details - K111908

510(k) Number K111908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2011
Decision Date November 29, 2011
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 767
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K111908.
HEADLESS COMPRESSION SCREW
K112672 · Skeletal Dynamics, LLC · Dec 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · Globus Medical, Inc. · Dec 2011
SYNTHES CORTICAL SCREWS
K112583 · Synthes USA Products, LLC · Dec 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · Smith & Nephew, Inc. · Oct 2011
ORTHOLOC(TM) BONE SCREWS
K112772 · Wrightmedicaltechnologyinc · Oct 2011
ZIMMER PERIARTICULAR SCREWS
K111447 · Zimmer, Inc. · Oct 2011