Cleared Traditional

K061577 - OVALTWIST PEDICLE SCREW SYSTEM

K061577 is an FDA 510(k) clearance for OVALTWIST PEDICLE SCREW SYSTEM, manufactured by Signus Medizintechnik GmbH. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K061577 · Signus Medizintechnik GmbH · Orthopedic device
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Sep 2006
Decision
99d
Days
Class 2
Risk

K061577 is an FDA 510(k) clearance for the OVALTWIST PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Signus Medizintechnik GmbH (Pleasant Grove, US). The FDA issued a Cleared decision on September 14, 2006 after a review of 99 days - within the typical 510(k) review window.

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 Signus Medizintechnik GmbH devices

FDA 510(k) Submission Details - K061577

510(k) Number K061577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2006
Decision Date September 14, 2006
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
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 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K061577.
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ISS INTEGRATED SPINE SYSTEM
K061524 · Ortho Development Corp. · Sep 2006
MANTIS SPINAL SYSTEM
K061813 · Stryker Spine · Sep 2006
SFX SNAP-FIT CROSS CONNECTOR
K062196 · Depuy Spine, Inc. · Sep 2006
PILOT POSTERIOR LUMBAR PLATING SYSTEM
K061364 · Life Spine · Sep 2006
MODIFICATION TO NUVASIVE SPHERX II SYSTEM
K062317 · Nuvasive, Inc. · Sep 2006