Cleared Traditional

K931693 - 1/3 TUBULAR PLATE

K931693 is an FDA 510(k) clearance for 1/3 TUBULAR PLATE, manufactured by Onyx Medical Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K931693 · Onyx Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
385d
Days
Class 2
Risk

K931693 is an FDA 510(k) clearance for the 1/3 TUBULAR PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), 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 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Onyx Medical Corp. devices

FDA 510(k) Submission Details - K931693

510(k) Number K931693 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 05, 1993
Decision Date April 25, 1994
Days to Decision 385 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
263d slower than avg
Panel avg: 122d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 946
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K931693.
SEMI-TUBULAR PLATE
K931688 · Onyx Medical Corp. · Apr 1994
SMALL STRAIGHT PLATE
K931689 · Onyx Medical Corp. · Apr 1994
STRAIGHT MINI-PLATE
K931691 · Onyx Medical Corp. · Apr 1994
1/4 TUBULAR PLATE
K931694 · Onyx Medical Corp. · Apr 1994
LUHR MINI BONE SCREW AND Z PLATE
K935448 · Howmedica Corp. · Feb 1994
BONE PLATE
K931244 · Acu Med, Inc. · Feb 1994