Cleared Special

K080885 - MEDACTA TOTAL HIP PROSTHESIS SYSTEM - L...

K080885 is the FDA 510(k) clearance for MEDACTA TOTAL HIP PROSTHESIS SYSTEM - L... by Medacta International S.A.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Special 510(k) pathway after a 28-day FDA review.

K080885 · Medacta International S.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2008
Decision
28d
Days
Class 2
Risk

K080885 is an FDA 510(k) clearance for the MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Medacta International S.A. (San Diego, US). The FDA issued a Cleared decision on April 28, 2008 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Medacta International S.A. devices

Submission Details

510(k) Number K080885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date April 28, 2008
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K080885.
BIOPRO FEMORAL HEADS
K090208 · Biopro, Inc. · May 2009
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
K082792 · Medacta International S.A. · Dec 2008
DEPUY C-STEM AMT
K082239 · DePuy Orthopaedics, Inc. · Aug 2008
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
K072857 · Medacta International S.A. · Feb 2008
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
K070399 · Biomet Manufacturing, Inc. · May 2007
100KGY E-POLY MAXROM ACETABULAR LINERS
K070364 · Biomet, Inc. · May 2007