Cleared Traditional

K032717 - BIOCRYL RAPIDE INTERFERENCE SCREW

K032717 is an FDA 510(k) clearance for BIOCRYL RAPIDE INTERFERENCE SCREW, manufactured by Mitek Worldwide. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K032717 · Mitek Worldwide · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
211d
Days
Class 2
Risk

K032717 is an FDA 510(k) clearance for the BIOCRYL RAPIDE INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Mitek Worldwide (Norwood, US). The FDA issued a Cleared decision on March 31, 2004 after a review of 211 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 Mitek Worldwide devices

FDA 510(k) Submission Details - K032717

510(k) Number K032717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date March 31, 2004
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 851
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K032717.
MICROMAX SUTURE ANCHOR
K040475 · Biomet, Inc. · May 2004
ENDOTINE TRANSBLEPH DEVICE
K040740 · Coapt Systems, Inc. · May 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · Smith & Nephew, Inc. · Apr 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · United States Surgical, A Division of Tyco Healthc · Mar 2004
BILOK ST SCREW
K033792 · Biocomposites, Ltd. · Mar 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004