Cleared Traditional

K081165 - ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM

K081165 is an FDA 510(k) clearance for ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS..., manufactured by Spineart. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K081165

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.

MNH Device Classification - Class 2, Special Controls

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 278
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K081165.
MESA SPINAL SYSTEM
K080611 · K2m, Inc. · Mar 2009
NOVEL SPINAL SYSTEM
K081153 · Medyssey Co, Ltd. · Jan 2009
LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
K083826 · Allez Spine, LLC · Jan 2009
EOS SPINAL SYSTEM
K082509 · Korea Bone Bank Co., Ltd. · Dec 2008
PASS LP SPINAL SYSTEM
K082577 · Medicrea Technologies · Oct 2008
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
K081883 · Us Spine · Sep 2008