Cleared Traditional

K073068 - ACCIN HIP SYSTEM

K073068 is an FDA 510(k) clearance for ACCIN HIP SYSTEM, manufactured by Accelerated Innovation, LLC. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K073068 · Accelerated Innovation, LLC · Orthopedic device
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Jan 2008
Decision
72d
Days
Class 2
Risk

K073068 is an FDA 510(k) clearance for the ACCIN HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Accelerated Innovation, LLC (Clifton, US). The FDA issued a Cleared decision on January 10, 2008 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Accelerated Innovation, LLC devices

FDA 510(k) Submission Details - K073068

510(k) Number K073068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2007
Decision Date January 10, 2008
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 492
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K073068.
APEX-LNK POLY ACETABULAR CUP LINERS
K073150 · Omni Life Science, Inc. · Feb 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · Smith & Nephew, Inc. · Jan 2008
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
K072888 · Encore Medical, L.P. · Jan 2008
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K072963 · DePuy Orthopaedics, Inc. · Jan 2008
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
K072154 · Encore Medical, L.P. · Dec 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · Smith & Nephew, Inc. · Oct 2007