Cleared Traditional

K021008 - ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL

K021008 is an FDA 510(k) clearance for ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANT..., manufactured by Advanced Orthopaedic Solutions, Inc.. The device is a Class 2 Orthopedic device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K021008

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
Combination Product No
PCCP Authorized No
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.

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 529
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K021008.
S2 FEMORAL NAIL
K022461 · Howmedica Osteonics · Aug 2002
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM
K022225 · Vector Medical, Inc. · Jul 2002
T2 FEMORAL NAIL
K021744 · Howmedica Osteonics Corp. · Jun 2002
G4 SLEEVED NAIL
K020962 · Biomet Manufacturing, Inc. · May 2002
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
K021324 · Disco-O-Tech Medical Technologies, Ltd. · May 2002
APEX INTRAMEDULLARY NAIL SYSTEM
K020562 · Magly Orthopedics, LLC · May 2002
K021008 · ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
Download PDF FDA Summary Advanced Orthopaedic …