Cleared Traditional

K992856 - MAGELLAN HUMERAL INTRAMEDULLARY NAIL

K992856 is an FDA 510(k) clearance for MAGELLAN HUMERAL INTRAMEDULLARY NAIL, manufactured by Orthomatrix, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K992856 · Orthomatrix, Inc. · Orthopedic device
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Mar 2000
Decision
199d
Days
Class 2
Risk

K992856 is an FDA 510(k) clearance for the MAGELLAN HUMERAL INTRAMEDULLARY NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthomatrix, Inc. (Collierville, US). The FDA issued a Cleared decision on March 10, 2000 after a review of 199 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 Orthomatrix, Inc. devices

FDA 510(k) Submission Details - K992856

510(k) Number K992856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1999
Decision Date March 10, 2000
Days to Decision 199 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
77d slower than avg
Panel avg: 122d · This submission: 199d
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 435
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K992856.
BROOKER FEMORAL NAILS
K002278 · Biomet Orthopedics, Inc. · Oct 2000
BROOKER TIBIA NAILS
K002057 · Biomet Orthopedics, Inc. · Oct 2000
MAGELLAN TIBIAL INTRAMEDULLARY NAIL
K992850 · Orthomatrix, Inc. · Mar 2000
TITANIUM PEDIATRIC FEMORAL NAIL
K993956 · Biomet, Inc. · Dec 1999
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
K993603 · Howmedica Osteonics Corp. · Nov 1999
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · Howmedica Osteonics Corp. · Nov 1999