Cleared Traditional

K123138 - PASS LP SPINAL SYSTEM

K123138 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 Traditional 510(k) pathway after a 123-day FDA review.

K123138 · Medicrea International · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
123d
Days
Class 2
Risk

K123138 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 February 5, 2013 after a review of 123 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 Medicrea International devices

FDA 510(k) Submission Details - K123138

510(k) Number K123138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 05, 2012
Decision Date February 05, 2013
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 12
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K123138.
RESPONSE SPINE SYSTEM
K130655 · OrthoPediatrics Corp. · May 2013
RANGE SPINAL SYSTEM
K130330 · K2m, Inc. · May 2013
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
K123412 · K2m, Inc. · Feb 2013
RANGE SPINAL SYSTEM
K121630 · K2m, Inc. · Sep 2012
OP SPINE SYSTEM
K121250 · OrthoPediatrics Corp. · Jun 2012
OP SPINE SYSTEM
K120291 · OrthoPediatrics Corp. · Apr 2012