Cleared Traditional

K082892 - REJUVENATE MONOLITHIC HIP SYSTEM

K082892 is an FDA 510(k) clearance for REJUVENATE MONOLITHIC HIP SYSTEM, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K082892 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 2008
Decision
90d
Days
Class 2
Risk

K082892 is an FDA 510(k) clearance for the REJUVENATE MONOLITHIC 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 December 29, 2008 after a review of 90 days - within the typical 510(k) review window.

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 - K082892

510(k) Number K082892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date December 29, 2008
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

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

All 152
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K082892.
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
K092143 · Aesculap Implant Systems, Inc. · Sep 2009
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
K091161 · Howmedica Osteonics Corp. · Jun 2009
VERSAFIT CUP DOUBLE MOBILITY SYSTEM
K083116 · Medacta International S.A. · Apr 2009
MDF REVISION HIP SYSTEM
K081124 · Smith & Nephew, Inc. · Jul 2008
REJUVENATE MODULAR HIP SYSTEM
K081044 · Howmedica Osteonics Corp. · Jun 2008
METHA HIP SYSTEM
K071916 · Aesculap Implant Systems, Inc. · Jun 2008