Cleared Traditional

K120074 - FOUNDATION SPINAL SYSTEM

K120074 is an FDA 510(k) clearance for FOUNDATION SPINAL SYSTEM, manufactured by The Skeletal Design Partnership , Ltd.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K120074 · The Skeletal Design Partnership , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
64d
Days
Class 2
Risk

K120074 is an FDA 510(k) clearance for the FOUNDATION SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by The Skeletal Design Partnership , Ltd. (Chesterland, US). The FDA issued a Cleared decision on March 14, 2012 after a review of 64 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 The Skeletal Design Partnership , Ltd. devices

FDA 510(k) Submission Details - K120074

510(k) Number K120074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2012
Decision Date March 14, 2012
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 747
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K120074.
VIPER SYSTEM
K121020 · Depuy Spine, Inc. · May 2012
TIGER SPINE SYSTEM
K113058 · Corelink, LLC · Mar 2012
VENUS SPINAL FIXATION SYSTEM
K120270 · L & K Biomed Co., Ltd. · Mar 2012
POWER ADAPTOR INSTRUMENT ACCESSORY
K120434 · Stryker Corp. · Mar 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · Orthofix, Inc. · Feb 2012
FOCUS SPINAL SYSTEM
K120140 · L & K Biomed Co., Ltd. · Feb 2012