Cleared Traditional

K933361 - ACUMED RADIUS ROD

K933361 is the FDA 510(k) clearance for ACUMED RADIUS ROD by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K933361 · Acu Med, Inc. · Orthopedic device
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Feb 1994
Decision
228d
Days
Class 2
Risk

K933361 is an FDA 510(k) clearance for the ACUMED RADIUS ROD. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 228 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 Acu Med, Inc. devices

Submission Details

510(k) Number K933361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1993
Decision Date February 22, 1994
Days to Decision 228 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 122d · This submission: 228d
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 K933361.
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ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL
K932593 · Synthes (Usa) · Mar 1994
THE MODULAR NAIL
K933027 · Smith & Nephew Richards, Inc. · Feb 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