Cleared Traditional

K934615 - CANCELLOUS BONE SCREW

K934615 is an FDA 510(k) clearance for CANCELLOUS BONE SCREW, manufactured by Onyx Medical Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K934615 · Onyx Medical Corp. · Orthopedic device
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Apr 1994
Decision
210d
Days
Class 2
Risk

K934615 is an FDA 510(k) clearance for the CANCELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Onyx Medical Corp. (Memphis, US). The FDA issued a Cleared decision on April 25, 1994 after a review of 210 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 Onyx Medical Corp. devices

FDA 510(k) Submission Details - K934615

510(k) Number K934615 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 27, 1993
Decision Date April 25, 1994
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K934615.
CANNULATED CANCELLOUS SCREW
K931680 · Onyx Medical Corp. · May 1994
CANNULATED NAVICULAR SCREW
K931681 · Onyx Medical Corp. · Apr 1994
CORTICAL BONE SCREW
K931790 · Onyx Medical Corp. · Apr 1994
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