Cleared Traditional

DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT (K132912) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 418
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K132912.
Arthrex Low Profile Screws
K143614 · Arthrex, Inc. · Jan 2015
PhaLinx Hammertoe System
K142585 · Wrightmedicaltechnologyinc · Nov 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · Zimmer, Inc. · Oct 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