Cleared Traditional

K933352 - CONCEPT CANNULATED INTEREFERENCE SCREW

K933352 is the FDA 510(k) clearance for CONCEPT CANNULATED INTEREFERENCE SCREW by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K933352 · Linvatec Corp. · Orthopedic device
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Feb 1994
Decision
229d
Days
Class 2
Risk

K933352 is an FDA 510(k) clearance for the CONCEPT CANNULATED INTEREFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on February 23, 1994 after a review of 229 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 Linvatec Corp. devices

Submission Details

510(k) Number K933352 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 09, 1993
Decision Date February 23, 1994
Days to Decision 229 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
107d slower than avg
Panel avg: 122d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 559
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K933352.
CANCELLOUS BONE SCREW
K934616 · Onyx Medical Corp. · Apr 1994
FULLY THREADED ALTA CANCELLOUS BONE SCREW
K931524 · Howmedica Corp. · Mar 1994
OREGON FIXATION SYSTEM INTERFERENCE SCREW
K932027 · Acu Med, Inc. · Feb 1994
M. KUROSAKA INTERFERENCE FIXATION SCREW
K933738 · Depuy, Inc. · Feb 1994
ARTHROTEK INTERFERENCE SCREW
K934469 · Biomet, Inc. · Feb 1994
6.5 MM CANCELLOUS BONE SCREW
K931665 · Encore Orthopedics, Inc. · Feb 1994