Cleared Traditional

K931692 - T-PLATE

K931692 is an FDA 510(k) clearance for T-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 394-day FDA review.

K931692 · Onyx Medical Corp. · Orthopedic device
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May 1994
Decision
394d
Days
Class 2
Risk

K931692 is an FDA 510(k) clearance for the T-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 May 4, 1994 after a review of 394 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 - K931692

510(k) Number K931692 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 05, 1993
Decision Date May 04, 1994
Days to Decision 394 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
272d slower than avg
Panel avg: 122d · This submission: 394d
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 K931692.
VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
K930480 · Smith & Nephew Richards, Inc. · Jun 1994
SPOON PLATE
K931690 · Onyx Medical Corp. · Jun 1994
EPIPHYSIS PLATE
K931684 · Onyx Medical Corp. · May 1994
MINI FRAGMENT PLATE
K934614 · Onyx Medical Corp. · May 1994
BUTTRESS PLATE
K931679 · Onyx Medical Corp. · Apr 1994
CLOVERLEAF PLATE
K931683 · Onyx Medical Corp. · Apr 1994