Cleared Traditional

K934366 - MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER

K934366 is an FDA 510(k) clearance for MITEK CANCELLOUS FIXATION SCREW, manufactured by Mitek Surgical Products, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K934366 · Mitek Surgical Products, Inc. · Orthopedic device
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Oct 1994
Decision
395d
Days
Class 2
Risk

K934366 is an FDA 510(k) clearance for the MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on October 7, 1994 after a review of 395 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 Mitek Surgical Products, Inc. devices

FDA 510(k) Submission Details - K934366

510(k) Number K934366 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 07, 1993
Decision Date October 07, 1994
Days to Decision 395 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 122d · This submission: 395d
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 951
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K934366.
PIONEER LABORATORIES CABLE SCREW
K941866 · Pioneer Surgical Technology · Nov 1994
PIONEER LABORATORIES BONE SCREW
K940690 · Pioneer Surgical Technology · Nov 1994
AIMS CANNULATED ACL SCREW
K943539 · Smith & Nephew, Inc. · Oct 1994
PIONEER LABORATORIES CABLE PIN
K941174 · Pioneer Surgical Technology · Sep 1994
STAPLE, FIXATION BONE
K931155 · Roseburg SA · Sep 1994
ARTHROTEK SET SCREW
K932721 · Biomet, Inc. · Aug 1994