Cleared Special

K132575 - PASS LP SPINAL SYSTEM

K132575 is an FDA 510(k) clearance for PASS LP SPINAL SYSTEM, manufactured by Medicrea International. The device is a Class 2 Orthopedic device with product code OSH cleared through the Special 510(k) pathway after a 48-day FDA review.

K132575 · Medicrea International · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
48d
Days
Class 2
Risk

K132575 is an FDA 510(k) clearance for the PASS LP SPINAL SYSTEM. Classified as Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH), Class II - Special Controls.

Submitted by Medicrea International (Neyron, FR). The FDA issued a Cleared decision on October 3, 2013 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132575

510(k) Number K132575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2013
Decision Date October 03, 2013
Days to Decision 48 days
Submission Type Special
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
74d faster than avg
Panel avg: 122d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

OSH Device Classification - Class 2, Special Controls

Product Code OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis.
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 - OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

All 18
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K132575.
CD HORIZON SPINAL SYSTEM
K140276 · Medtronic Sofamor Danek · Mar 2014
PASS LP SPINAL SYSTEM
K132574 · Medicrea International · Nov 2013
IMPLANET SPINE SYSTEM
K132303 · Implanet, S.A. · Oct 2013
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
K131802 · Depuy Spine, A Johnson & Johnson Company · Sep 2013
POLARIS SPINAL SYSTEM
K131615 · Biomet Spine (Aka Ebi, LLC) · Sep 2013
RANGE SPINAL SYSTEM
K131784 · K2m, Inc. · Aug 2013