Cleared Traditional

K934590 - IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS

K934590 is an FDA 510(k) clearance for IMPROVED PASSIVATION METHOD FOR METALLI..., manufactured by Smith & Nephew Richards, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 628-day FDA review.

K934590 · Smith & Nephew Richards, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
628d
Days
Class 2
Risk

K934590 is an FDA 510(k) clearance for the IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 628 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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

FDA 510(k) Submission Details - K934590

510(k) Number K934590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date June 14, 1995
Days to Decision 628 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
506d slower than avg
Panel avg: 122d · This submission: 628d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 981
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K934590.
K4 BONE SCREW SYSTEM
K950704 · Kinetikos Medical, Inc. · Jun 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652 · Osteotech, Inc. · Jun 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · Synthes (Usa) · Jun 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · Linvatec Corp. · May 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330 · Acu Med, Inc. · May 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426 · Arthrex, Inc. · Apr 1995