Cleared Traditional

K113591 - COLS PEEK

K113591 is an FDA 510(k) clearance for COLS PEEK, 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 17-day FDA review.

K113591 · Fournitures Hospitalieres Industrie · Orthopedic device
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Dec 2011
Decision
17d
Days
Class 2
Risk

K113591 is an FDA 510(k) clearance for the COLS PEEK. 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 December 22, 2011 after a review of 17 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 - K113591

510(k) Number K113591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date December 22, 2011
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
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 1015
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K113591.
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