Cleared Traditional

ISSYS PEDICLE SCREW SYSTEM (K043522) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043522 · Custom Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
25d
Days
Class 2
Risk

K043522 is an FDA 510(k) clearance for the ISSYS PEDICLE SCREW SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Custom Spine, Inc. (Conway, US). The FDA issued a Cleared decision on January 14, 2005 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Custom Spine, Inc. devices

Submission Details

510(k) Number K043522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2004
Decision Date January 14, 2005
Days to Decision 25 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 68
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K043522.
SYNTHES PANGEA SYSTEM
K052123 · Synthes (Usa) · Sep 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069 · Globus Medical, Inc. · Aug 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391 · Globus Medical, Inc. · Jul 2005
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175 · Synthes (Usa) · Nov 2003
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · Howmedica Osteonics Corp. · Jul 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · Howmedica Osteonics Corp. · Apr 2003