Cleared Special

K081044 - REJUVENATE MODULAR HIP SYSTEM

K081044 is the FDA 510(k) clearance for REJUVENATE MODULAR HIP SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MEH) cleared through the Special 510(k) pathway after a 50-day FDA review.

K081044 · Howmedica Osteonics Corp. · Orthopedic device
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Jun 2008
Decision
50d
Days
Class 2
Risk

K081044 is an FDA 510(k) clearance for the REJUVENATE MODULAR HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on June 3, 2008 after a review of 50 days - a notably fast clearance cycle.

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

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K081044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date June 03, 2008
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

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