Cleared Traditional

K080974 - TLS FIXATION SYSTEM

K080974 is an FDA 510(k) clearance for TLS FIXATION SYSTEM, manufactured by Fournitures Hospitalieres Industrie. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K080974 · Fournitures Hospitalieres Industrie · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
88d
Days
Class 2
Risk

K080974 is an FDA 510(k) clearance for the TLS FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Fournitures Hospitalieres Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on July 1, 2008 after a review of 88 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 Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K080974

510(k) Number K080974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2008
Decision Date July 01, 2008
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K080974.
BIOPRO GO-EZ SCREW
K081149 · Biopro, Inc. · Aug 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513 · Merete Medical GmbH · Jul 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
K081428 · Biocomposites, Ltd. · Jun 2008
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
K080088 · Biomet Manufacturing, Inc. · Jun 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071 · Synthes (Usa) · May 2008