Cleared Special

K022461 - S2 FEMORAL NAIL

K022461 is an FDA 510(k) clearance for S2 FEMORAL NAIL, manufactured by Howmedica Osteonics. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 27-day FDA review.

K022461 · Howmedica Osteonics · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
27d
Days
Class 2
Risk

K022461 is an FDA 510(k) clearance for the S2 FEMORAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Osteonics (Allendale, US). The FDA issued a Cleared decision on August 22, 2002 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022461

510(k) Number K022461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2002
Decision Date August 22, 2002
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 512
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K022461.
SIGN IM NAIL
K022632 · Surgical Implant Generation Network (Sign) · Sep 2002
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · Biomet, Inc. · Aug 2002
S2 TIBIAL NAIL
K022481 · Howmedica Osteonics Corp. · Aug 2002
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM
K022225 · Vector Medical, Inc. · Jul 2002
T2 FEMORAL NAIL
K021744 · Howmedica Osteonics Corp. · Jun 2002
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
K021008 · Advanced Orthopaedic Solutions, Inc. · Jun 2002
K022461 · S2 FEMORAL NAIL
Download PDF FDA Summary Howmedica Osteonics