Cleared Traditional

K111230 - SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW

K111230 is the FDA 510(k) clearance for SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K111230 · Synthes USA Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
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May 2011
Decision
22d
Days
Class 2
Risk

K111230 is an FDA 510(k) clearance for the SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on May 24, 2011 after a review of 22 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K111230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2011
Decision Date May 24, 2011
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
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 585
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K111230.
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · Synthes (Usa) · Jul 2011
AAP CANNULATED SCREWS
K111316 · Aap Implantate AG · Jul 2011
APTUS CANNULATED COMPRESSION SCREWS
K110658 · Medartis AG · Jun 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · Wrightmedicaltechnologyinc · May 2011
LOW PROFILE SCREWS
K103705 · Arthrex, Inc. · Mar 2011
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
K103712 · Depuy Mitek, A Johnson & Johnson Company · Mar 2011