Cleared Traditional

K931688 - SEMI-TUBULAR PLATE

K931688 is an FDA 510(k) clearance for SEMI-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.

K931688 · Onyx Medical Corp. · Orthopedic device
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Apr 1994
Decision
385d
Days
Class 2
Risk

K931688 is an FDA 510(k) clearance for the SEMI-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 - K931688

510(k) Number K931688 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 K931688.
CLOVERLEAF PLATE
K931683 · Onyx Medical Corp. · Apr 1994
FOREARM SELF COMPRESSION PLATE
K931685 · Onyx Medical Corp. · Apr 1994
MULTIPLE FRAGMENT PLATE
K931687 · Onyx Medical Corp. · Apr 1994
SMALL STRAIGHT PLATE
K931689 · Onyx Medical Corp. · Apr 1994
STRAIGHT MINI-PLATE
K931691 · Onyx Medical Corp. · Apr 1994
1/3 TUBULAR PLATE
K931693 · Onyx Medical Corp. · Apr 1994