Cleared Traditional

K080539 - ACCIN UNIPOLAR HEAD SYSTEM

K080539 is an FDA 510(k) clearance for ACCIN UNIPOLAR HEAD SYSTEM, manufactured by Accelerated Innovation, LLC. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K080539 · Accelerated Innovation, LLC · Orthopedic device
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Jun 2008
Decision
96d
Days
Class 2
Risk

K080539 is an FDA 510(k) clearance for the ACCIN UNIPOLAR HEAD SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Accelerated Innovation, LLC (Clifton, US). The FDA issued a Cleared decision on June 2, 2008 after a review of 96 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 Accelerated Innovation, LLC devices

FDA 510(k) Submission Details - K080539

510(k) Number K080539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2008
Decision Date June 02, 2008
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 499
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K080539.
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
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
K080885 · Medacta International S.A. · Apr 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