Cleared Traditional

TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT (K072857) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072857 · Medacta International S.A. · Orthopedic device
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Feb 2008
Decision
122d
Days
Class 2
Risk

K072857 is an FDA 510(k) clearance for the TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Medacta International S.A. (Norfolk, US). The FDA issued a Cleared decision on February 4, 2008 after a review of 122 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K072857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2007
Decision Date February 04, 2008
Days to Decision 122 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 122d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K072857.
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