Cleared Traditional

K131920 - STABILIZATION SCREW

K131920 is an FDA 510(k) clearance for STABILIZATION SCREW, 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 309-day FDA review.

K131920 · In2bones Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
309d
Days
Class 2
Risk

K131920 is an FDA 510(k) clearance for the STABILIZATION SCREW. 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 May 1, 2014 after a review of 309 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 - K131920

510(k) Number K131920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2013
Decision Date May 01, 2014
Days to Decision 309 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
187d slower than avg
Panel avg: 122d · This submission: 309d
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 K131920.
SALVATION BEAMS AND BOLTS SYSTEM
K140741 · Wrightmedicaltechnologyinc · May 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952 · Wrightmedicaltechnologyinc · May 2014
SALVATION OSTEOPENIC SCREW
K140408 · Wrightmedicaltechnologyinc · May 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636 · Extremity Medical, LLC · Mar 2014
TYBER MEDICAL TRAUMA SCREW
K133842 · Tyber Medical, LLC · Mar 2014
CHARLOTTE (TM) SNAP-OFF SCREW
K133713 · Wrightmedicaltechnologyinc · Mar 2014