Cleared Traditional

K113399 - IFS SUBTALAR IMPLANT

K113399 is an FDA 510(k) clearance for IFS SUBTALAR IMPLANT, manufactured by Internal Fixation Systems, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K113399 · Internal Fixation Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
33d
Days
Class 2
Risk

K113399 is an FDA 510(k) clearance for the IFS SUBTALAR IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Internal Fixation Systems, Inc. (Miami, US). The FDA issued a Cleared decision on December 20, 2011 after a review of 33 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 - K113399

510(k) Number K113399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2011
Decision Date December 20, 2011
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
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 K113399.
MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
K112727 · Medical Facets · Jan 2012
DYNA LOCKING CANNULATED SCREW
K112240 · U&I Corp. · Jan 2012
COLS PEEK
K113591 · Fournitures Hospitalieres Industrie · Dec 2011
ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
K110895 · Ortho Solutions Limited · Dec 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · Zimmer, Inc. · Dec 2011
HEADLESS COMPRESSION SCREW
K112672 · Skeletal Dynamics, LLC · Dec 2011
K113399 · IFS SUBTALAR IMPLANT
Download PDF FDA Summary Internal Fixation Sys…