Cleared Traditional

K063668 - ROC LUMBAR SYSTEM

K063668 is the FDA 510(k) clearance for ROC LUMBAR SYSTEM by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K063668 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
158d
Days
Class 2
Risk

K063668 is an FDA 510(k) clearance for the ROC LUMBAR SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 18, 2007 after a review of 158 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K063668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2006
Decision Date May 18, 2007
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K063668.
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187 · Pioneer Surgical Technology · Oct 2007
Optima ZS Transition Screw
K071880 · Zimmer Spine, Inc. · Oct 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007
CAPSURE PEDICLE SCREW SYSTEM
K070245 · Spine Wave, Inc. · Apr 2007
PILOT SPINAL SYSTEM
K063601 · Life Spine · Jan 2007