Cleared Traditional

K926213 - MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM

K926213 is an FDA 510(k) clearance for MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM, manufactured by Osteo Technology, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K926213 · Osteo Technology, Inc. · Orthopedic device
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Jun 1993
Decision
189d
Days
Class 2
Risk

K926213 is an FDA 510(k) clearance for the MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on June 17, 1993 after a review of 189 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 Osteo Technology, Inc. devices

FDA 510(k) Submission Details - K926213

510(k) Number K926213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1992
Decision Date June 17, 1993
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 387
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K926213.
THE MODULAR NAIL
K933027 · Smith & Nephew Richards, Inc. · Feb 1994
ACUMED RADIUS ROD
K933361 · Acu Med, 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
SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL
K923580 · Synthes (Usa) · Jan 1993