Cleared Traditional

K110445 - FLEXFUSION (TM) FIXATION IMPLANT

K110445 is an FDA 510(k) clearance for FLEXFUSION (TM) FIXATION IMPLANT, manufactured by Nextremity Solutions, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K110445 · Nextremity Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
29d
Days
Class 2
Risk

K110445 is an FDA 510(k) clearance for the FLEXFUSION (TM) FIXATION IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Nextremity Solutions, LLC (Colts Neck, US). The FDA issued a Cleared decision on March 17, 2011 after a review of 29 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 Nextremity Solutions, LLC devices

FDA 510(k) Submission Details - K110445

510(k) Number K110445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2011
Decision Date March 17, 2011
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 759
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K110445.
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230 · Synthes USA Products, LLC · May 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
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
K102298 · Depuy Mitek, A Johnson & Johnson Company · Jan 2011
MATRYX INTERFERENCE SCREW (5.0-6.5MM)
K102410 · Conmed Linvatec · Dec 2010