Cleared Traditional

K141949 - CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM

K141949 is an FDA 510(k) clearance for CORTICAL SCREW 3.5, manufactured by Aap Implantate AG. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K141949 · Aap Implantate AG · Orthopedic device
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Sep 2014
Decision
56d
Days
Class 2
Risk

K141949 is an FDA 510(k) clearance for the CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SEL.... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on September 12, 2014 after a review of 56 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 Aap Implantate AG devices

FDA 510(k) Submission Details - K141949

510(k) Number K141949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2014
Decision Date September 12, 2014
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K141949.
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · Zimmer, Inc. · Oct 2014
HyProCure II
K142534 · Graham Medical Technologies, LLC Dba Gramedica · Oct 2014
HELICAL RIDGE PEEK INTERFERENCE SCREW
K141290 · MedShape, Inc. · Sep 2014
TRIDENT FUSION IMPLANT
K141937 · Vilex IN Tennessee, Inc. · Sep 2014
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
K132912 · In2bones Sas · Jul 2014
NORMED VARIO SUBTALAR SCREW
K140962 · Normed Nedizin Technik GmbH · Jul 2014