Cleared Traditional

THE MODULAR NAIL (K933027) - FDA 510(k) Clearance

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

K933027 · Smith & Nephew Richards, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
245d
Days
Class 2
Risk

K933027 is an FDA 510(k) clearance for the THE MODULAR NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 245 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K933027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date February 22, 1994
Days to Decision 245 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
123d slower than avg
Panel avg: 122d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K933027.
ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION
K935295 · Howmedica Corp. · Oct 1994
SYNTHES UNREAMED HUMERAL NAIL (URHN)
K933518 · Synthes (Usa) · Mar 1994
ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL
K932593 · Synthes (Usa) · Mar 1994
SEIDEL HUMERAL LOCKING NAIL
K931256 · Howmedica Corp. · Jul 1993
ALTA CFX ROD SYSTEM
K926232 · Howmedica Corp. · Jun 1993
SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS
K925544 · Howmedica Corp. · Mar 1993