Cleared Traditional

K934614 - MINI FRAGMENT PLATE

K934614 is an FDA 510(k) clearance for MINI FRAGMENT 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 219-day FDA review.

K934614 · Onyx Medical Corp. · Orthopedic device
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May 1994
Decision
219d
Days
Class 2
Risk

K934614 is an FDA 510(k) clearance for the MINI FRAGMENT 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 219 days - an extended review cycle.

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. 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 - K934614

510(k) Number K934614 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 27, 1993
Decision Date May 04, 1994
Days to Decision 219 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
97d slower than avg
Panel avg: 122d · This submission: 219d
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 K934614.
SPOON PLATE
K931690 · Onyx Medical Corp. · Jun 1994
EPIPHYSIS PLATE
K931684 · Onyx Medical Corp. · May 1994
T-PLATE
K931692 · Onyx Medical Corp. · May 1994
BUTTRESS PLATE
K931679 · Onyx Medical Corp. · Apr 1994
CLOVERLEAF PLATE
K931683 · Onyx Medical Corp. · Apr 1994
FOREARM SELF COMPRESSION PLATE
K931685 · Onyx Medical Corp. · Apr 1994