Cleared Traditional

K130655 - RESPONSE SPINE SYSTEM

K130655 is the FDA 510(k) clearance for RESPONSE SPINE SYSTEM by OrthoPediatrics Corp.. It is a Class 2 Orthopedic device (product code OSH) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K130655 · OrthoPediatrics Corp. · Orthopedic device
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May 2013
Decision
57d
Days
Class 2
Risk

K130655 is an FDA 510(k) clearance for the RESPONSE SPINE SYSTEM. Classified as Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH), Class II - Special Controls.

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on May 8, 2013 after a review of 57 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. 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 OrthoPediatrics Corp. devices

Submission Details

510(k) Number K130655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date May 08, 2013
Days to Decision 57 days
Submission Type Traditional
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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K130655.
CREO STABILIZATION SYSTEM
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RANGE SPINAL SYSTEM, SMALL STATURE
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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