Cleared Traditional

Spinal System (K240963) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240963 · Teslake, Inc. · Orthopedic device
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Jun 2024
Decision
58d
Days
Class 2
Risk

K240963 is an FDA 510(k) clearance for the 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 Teslake, Inc. (San Diego, US). The FDA issued a Cleared decision on June 6, 2024 after a review of 58 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 Teslake, Inc. devices

Submission Details

510(k) Number K240963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2024
Decision Date June 06, 2024
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K240963.
Pantheon Pedicle Screw and Iliac Bolt Fixation System
K241494 · Pantheon Spinal · Jul 2024
Erisma® Lp Spinal Fixation System
K241863 · Clariance · Jul 2024
Invictus® Small Stature Spinal Fixation System
K241519 · Alphatec Spine, Inc. · Jun 2024
Ingenix Spinal System
K241258 · Ingenium Spine · Jun 2024
Vector™ Pedicle Screw System
K241276 · Innovasis, Inc. · May 2024
JAZZ Spinal System
K240392 · Implanet · May 2024