Cleared Traditional

K933518 - SYNTHES UNREAMED HUMERAL NAIL (URHN)

K933518 is an FDA 510(k) clearance for SYNTHES UNREAMED HUMERAL NAIL (URHN), manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with 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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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

FDA 510(k) Submission Details - K933518

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.

HSB Device Classification - Class 2, Special Controls

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 460
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