Cleared Traditional

K001044 - ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM

K001044 is an FDA 510(k) clearance for ACME SPINE SYSTEM - SERIES 6000, manufactured by Acme Spine, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K001044 · Acme Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
217d
Days
Class 2
Risk

K001044 is an FDA 510(k) clearance for the ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Acme Spine, LLC (Riverside, US). The FDA issued a Cleared decision on November 3, 2000 after a review of 217 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 Acme Spine, LLC devices

FDA 510(k) Submission Details - K001044

510(k) Number K001044 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 31, 2000
Decision Date November 03, 2000
Days to Decision 217 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 122d · This submission: 217d
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 206
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K001044.
CD HORIZON SPINAL SYSTEM
K000641 · Medtronic Sofamor Danek, Inc. · Dec 2000
OPUS ROD FIXATION SYSTEM
K003490 · Howmedica Osteonics Corp. · Dec 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384 · Osteotech, Inc. · Nov 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · Medtronic Sofamor Danek, Inc. · Sep 2000
CD HORIZON SPINAL SYSTEM
K001255 · Medtronic Sofamor Danek, Inc. · Jul 2000
CD HORIZON ECLIPSE
K001066 · Medtronic Sofamor Danek, Inc. · Jun 2000