Cleared Traditional

K934469 - ARTHROTEK INTERFERENCE SCREW

K934469 is an FDA 510(k) clearance for ARTHROTEK INTERFERENCE SCREW, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K934469 · Biomet, Inc. · Orthopedic device
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Feb 1994
Decision
166d
Days
Class 2
Risk

K934469 is an FDA 510(k) clearance for the ARTHROTEK INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 23, 1994 after a review of 166 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K934469

510(k) Number K934469 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 10, 1993
Decision Date February 23, 1994
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
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 982
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K934469.
OREGON FIXATION SYSTEM INTERFERENCE SCREW
K932027 · Acu Med, Inc. · Feb 1994
CONCEPT CANNULATED INTEREFERENCE SCREW
K933352 · Linvatec Corp. · Feb 1994
M. KUROSAKA INTERFERENCE FIXATION SCREW
K933738 · Depuy, Inc. · Feb 1994
6.5 MM CANCELLOUS BONE SCREW
K931665 · Encore Orthopedics, Inc. · Feb 1994
INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW
K930980 · Instrument Makar, Inc. · Feb 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187 · Implex Corp. · Feb 1994