Cleared Traditional

K081165 - ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS...

K081165 is the FDA 510(k) clearance for ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS... by Spineart. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K081165 · Spineart · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
237d
Days
Class 2
Risk

K081165 is an FDA 510(k) clearance for the ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on December 17, 2008 after a review of 237 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 Spineart devices

Submission Details

510(k) Number K081165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2008
Decision Date December 17, 2008
Days to Decision 237 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
115d slower than avg
Panel avg: 122d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K081165.
FORTEX PEDICLE SCREW SYSTEM
K090224 · X-Spine Systems, Inc. · Jul 2009
ROC LUMBAR PLATING SYSTEM
K090228 · Alphatec Spine, Inc. · Apr 2009
MESA SPINAL SYSTEM
K080611 · K2m, Inc. · Mar 2009
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · Depuy Spine, Inc. · Jun 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890 · Alphatec Spine, Inc. · Nov 2007