Cleared Traditional

K083912 - TREU

Also marketed or referenced as:
BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS

K083912 is an FDA 510(k) clearance for TREU, manufactured by Treu-Instrumente GmbH. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K083912 · Treu-Instrumente GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
197d
Days
Class 2
Risk

K083912 is an FDA 510(k) clearance for the TREU. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Treu-Instrumente GmbH (Mühlheim An Der Donau, DE). The FDA issued a Cleared decision on July 15, 2009 after a review of 197 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Treu-Instrumente GmbH devices

FDA 510(k) Submission Details - K083912

510(k) Number K083912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2008
Decision Date July 15, 2009
Days to Decision 197 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
75d slower than avg
Panel avg: 122d · This submission: 197d
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 778
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K083912.
MERETE COMPRESSION SCREWS
K091798 · Merete Medical GmbH · Sep 2009
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949 · Synthes (Usa) · Jul 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
K091577 · Extremity Medical, LLC · Jul 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · Smith & Nephew, Inc. · Jun 2009
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
K091069 · Medacta International S.A. · Jun 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
K082934 · Extremity Medical, LLC · Apr 2009