Cleared Traditional

K931690 - SPOON PLATE

K931690 is an FDA 510(k) clearance for SPOON 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 428-day FDA review.

K931690 · Onyx Medical Corp. · Orthopedic device
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Jun 1994
Decision
428d
Days
Class 2
Risk

K931690 is an FDA 510(k) clearance for the SPOON 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 June 7, 1994 after a review of 428 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Onyx Medical Corp. devices

FDA 510(k) Submission Details - K931690

510(k) Number K931690 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 05, 1993
Decision Date June 07, 1994
Days to Decision 428 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
306d slower than avg
Panel avg: 122d · This submission: 428d
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 K931690.
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853 · Wrightmedicaltechnologyinc · Jan 1995
PELVIC RADIUS PLATE
K936233 · Smith & Nephew Richards, Inc. · Aug 1994
VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
K930480 · Smith & Nephew Richards, Inc. · Jun 1994
EPIPHYSIS PLATE
K931684 · Onyx Medical Corp. · May 1994
T-PLATE
K931692 · Onyx Medical Corp. · May 1994
MINI FRAGMENT PLATE
K934614 · Onyx Medical Corp. · May 1994