Cleared Traditional

K933518 - SYNTHES UNREAMED HUMERAL NAIL (URHN)

K933518 is the FDA 510(k) clearance for SYNTHES UNREAMED HUMERAL NAIL (URHN) by Synthes (Usa). It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K933518 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
237d
Days
Class 2
Risk

K933518 is an FDA 510(k) clearance for the SYNTHES UNREAMED HUMERAL NAIL (URHN). Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 14, 1994 after a review of 237 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 Synthes (Usa) devices

Submission Details

510(k) Number K933518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1993
Decision Date March 14, 1994
Days to Decision 237 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
115d slower than avg
Panel avg: 122d · This submission: 237d
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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K933518.
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
K951673 · Acu Med, Inc. · Jul 1995
TIBIA-TALUS-CALCANEUS NAIL
K950394 · Smith & Nephew Richards, Inc. · May 1995
ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION
K935295 · Howmedica Corp. · Oct 1994
ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL
K932593 · Synthes (Usa) · Mar 1994
THE MODULAR NAIL
K933027 · Smith & Nephew Richards, Inc. · Feb 1994
ACUMED RADIUS ROD
K933361 · Acu Med, Inc. · Feb 1994