Cleared Traditional

K080647 - ACCIN BIPOLAR HEAD SYSTEM

K080647 is an FDA 510(k) clearance for ACCIN BIPOLAR HEAD SYSTEM, manufactured by Accelerated Innovation, LLC. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K080647 · Accelerated Innovation, LLC · Orthopedic device
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Jul 2008
Decision
123d
Days
Class 2
Risk

K080647 is an FDA 510(k) clearance for the ACCIN BIPOLAR HEAD SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Accelerated Innovation, LLC (Clifton, US). The FDA issued a Cleared decision on July 8, 2008 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 - K080647

510(k) Number K080647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2008
Decision Date July 08, 2008
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 87
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K080647.
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
K082468 · Omni Life Science, Inc. · Feb 2009
BIOPRO BIPOLAR HEAD, MODELS 18130-18152
K082705 · Biopro, Inc. · Dec 2008
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
K080979 · Biomet Manufacturing Corp · Oct 2008
GLADIATOR BIPOLAR SYSTEM
K062693 · Wrightmedicaltechnologyinc · Sep 2006
AESCULAP BIPOLAR ACETABULAR CUP
K060707 · Aesculap, Inc. · May 2006
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
K052990 · Biomet, Inc. · Dec 2005