Cleared Traditional

K072857 - TOTAL HIP PROSTHESIS SYSTEM QUADRA S + ...

K072857 is the FDA 510(k) clearance for TOTAL HIP PROSTHESIS SYSTEM QUADRA S + ... by Medacta International S.A.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

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
Combination Product No
PCCP Authorized No
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K072857.
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
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
K080885 · Medacta International S.A. · Apr 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
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
K061344 · Aesculap, Inc. · Aug 2006