Cleared Traditional

K930480 - VARIABLE ANGULAR HOLD BONE PLATE SYSTEM

K930480 is the FDA 510(k) clearance for VARIABLE ANGULAR HOLD BONE PLATE SYSTEM by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 502-day FDA review.

K930480 · Smith & Nephew Richards, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 1994
Decision
502d
Days
Class 2
Risk

K930480 is an FDA 510(k) clearance for the VARIABLE ANGULAR HOLD BONE PLATE SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on June 15, 1994 after a review of 502 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K930480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1993
Decision Date June 15, 1994
Days to Decision 502 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
380d slower than avg
Panel avg: 122d · This submission: 502d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 945
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K930480.
LUHR(R) TITANIUM BURR HOLE COVERS
K950115 · Howmedica, Inc. · Apr 1995
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853 · Wrightmedicaltechnologyinc · Jan 1995
PELVIC RADIUS PLATE
K936233 · Smith & Nephew Richards, Inc. · Aug 1994
SPOON PLATE
K931690 · Onyx Medical Corp. · Jun 1994
EPIPHYSIS PLATE
K931684 · Onyx Medical Corp. · May 1994
T-PLATE
K931692 · Onyx Medical Corp. · May 1994