Cleared Traditional

K123604 - ABG III MONOLITHIC HIP STEM

K123604 is an FDA 510(k) clearance for ABG III MONOLITHIC HIP STEM, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code MAY cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K123604 · Howmedica Osteonics Corp. · Orthopedic device
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Aug 2013
Decision
268d
Days
Class 2
Risk

K123604 is an FDA 510(k) clearance for the ABG III MONOLITHIC HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish (product code MAY), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on August 16, 2013 after a review of 268 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K123604

510(k) Number K123604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date August 16, 2013
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAY Device Classification - Class 2, Special Controls

Product Code MAY Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MAY Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish

Devices cleared under the same product code (MAY) and FDA review panel - the closest regulatory comparables to K123604.
ABG II MONOLITHIC HIP STEM
K110807 · Stryker Corp. · May 2011
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K090103 · Biomet, Inc. · Feb 2009
EQUATOR PLUS ACETABULAR CUP SYSTEM
K051844 · Portland Orthopaedics Pty. , Ltd. · Oct 2005