Cleared Traditional

K021008 - ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANT...

K021008 is the FDA 510(k) clearance for ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANT... by Advanced Orthopaedic Solutions, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K021008 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
84d
Days
Class 2
Risk

K021008 is an FDA 510(k) clearance for the ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (San Pedro, US). The FDA issued a Cleared decision on June 20, 2002 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Orthopaedic Solutions, Inc. devices

Submission Details

510(k) Number K021008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2002
Decision Date June 20, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
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 319
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K021008.
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · Biomet, Inc. · Aug 2002
S2 TIBIAL NAIL
K022481 · Howmedica Osteonics Corp. · Aug 2002
T2 FEMORAL NAIL
K021744 · Howmedica Osteonics Corp. · Jun 2002
T2 ARTHRODESIS NAIL SYSTEM
K020384 · Howmedica Osteonics Corp. · May 2002
S2 FEMORAL NAIL
K021026 · Howmedica Osteonics Corp. · Apr 2002
S2 TIBIAL NAIL
K021027 · Howmedica Osteonics Corp. · Apr 2002