Cleared Special

K082792 - MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS

K082792 is an FDA 510(k) clearance for MEDACTA TOTAL HIP PROSTHESIS SYSTEM - Q..., manufactured by Medacta International S.A.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 97-day FDA review.

K082792 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
97d
Days
Class 2
Risk

K082792 is an FDA 510(k) clearance for the MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS. 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 December 29, 2008 after a review of 97 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082792

510(k) Number K082792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2008
Decision Date December 29, 2008
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

JDI Device Classification - Class 2, Special Controls

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 564
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K082792.
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
BIOPRO FEMORAL HEADS
K090208 · Biopro, Inc. · May 2009
DEPUY C-STEM AMT
K082239 · DePuy Orthopaedics, Inc. · Aug 2008
ACCIN UNIPOLAR HEAD SYSTEM
K080539 · Accelerated Innovation, LLC · Jun 2008
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
K080885 · Medacta International S.A. · Apr 2008
K082792 · MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
Download PDF FDA Summary Medacta International…