Cleared Traditional

K121630 - RANGE SPINAL SYSTEM

K121630 is an FDA 510(k) clearance for RANGE SPINAL SYSTEM, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code OSH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K121630 · K2m, Inc. · Orthopedic device
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Sep 2012
Decision
99d
Days
Class 2
Risk

K121630 is an FDA 510(k) clearance for the RANGE SPINAL SYSTEM. Classified as Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on September 11, 2012 after a review of 99 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 K2m, Inc. devices

FDA 510(k) Submission Details - K121630

510(k) Number K121630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 04, 2012
Decision Date September 11, 2012
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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 18
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K121630.
RANGE SPINAL SYSTEM
K130330 · K2m, Inc. · May 2013
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
K123412 · K2m, Inc. · Feb 2013
PASS LP SPINAL SYSTEM
K123138 · Medicrea International · Feb 2013
OP SPINE SYSTEM
K121250 · OrthoPediatrics Corp. · Jun 2012
OP SPINE SYSTEM
K120291 · OrthoPediatrics Corp. · Apr 2012