Cleared Special

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION (K080885) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080885 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
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
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 276
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K080885.
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
K093646 · DePuy Orthopaedics, Inc. · Dec 2009
DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
K090998 · DePuy Orthopaedics, Inc. · Jun 2009
DEPUY C-STEM AMT
K082239 · DePuy Orthopaedics, Inc. · Aug 2008
100KGY E-POLY MAXROM ACETABULAR LINERS
K070364 · Biomet, Inc. · May 2007
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
K061344 · Aesculap, Inc. · Aug 2006
SYSTEM 12 X3 ACETABULAR INSERTS
K052748 · Howmedica Osteonics Corp. · Dec 2005