Cleared Traditional

VARIABLE ANGULAR HOLD BONE PLATE SYSTEM (K930480) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930480 · Smith & Nephew Richards, Inc. · Orthopedic device
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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
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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K930480.
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856 · Wrightmedicaltechnologyinc · May 1995
LUHR(R) TITANIUM ALLOY BURR HOLE COVERS
K950105 · Howmedica Corp. · Apr 1995
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853 · Wrightmedicaltechnologyinc · Jan 1995
LUHR MINI BONE SCREW AND Z PLATE
K935448 · Howmedica Corp. · Feb 1994
LUHR PAN FIXATION SYSTEM
K923861 · Howmedica Corp. · Mar 1993
DALL MILES BROAD BONE PLATE
K922525 · Howmedica Corp. · Sep 1992