Cleared Traditional

K132912 - DUAFIT INTERGPHALANGEAL IMPLANT

K132912 is an FDA 510(k) clearance for DUAFIT INTERGPHALANGEAL IMPLANT, manufactured by In2bones Sas. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K132912 · In2bones Sas · Orthopedic device
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Jul 2014
Decision
316d
Days
Class 2
Risk

K132912 is an FDA 510(k) clearance for the DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by In2bones Sas (Potomac, US). The FDA issued a Cleared decision on July 30, 2014 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 In2bones Sas devices

FDA 510(k) Submission Details - K132912

510(k) Number K132912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2013
Decision Date July 30, 2014
Days to Decision 316 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
194d slower than avg
Panel avg: 122d · This submission: 316d
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 691
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K132912.
Biomet Headless Compression and Twist-off Screws
K142658 · Biomet Manufacturing Corp · Nov 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · Zimmer, Inc. · Oct 2014
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
K141949 · Aap Implantate AG · Sep 2014
BIOMET CANNULATED SCREW SYSTEM
K140891 · Biomet, Inc. · Jun 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
K133662 · Smith & Nephew, Inc. · May 2014
SALVATION BEAMS AND BOLTS SYSTEM
K140741 · Wrightmedicaltechnologyinc · May 2014