Cleared Traditional

K231069 - PERLA TL Posterior Thoraco-lumbar Fixat...

K231069 is an FDA 510(k) clearance for PERLA TL Posterior Thoraco-lumbar Fixat..., manufactured by Spineart SA. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K231069 · Spineart SA · Orthopedic device
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Oct 2023
Decision
194d
Days
Class 2
Risk

K231069 is an FDA 510(k) clearance for the PERLA® TL Posterior Thoraco-lumbar Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Spineart SA (Plan-Les-Ouates, CH). The FDA issued a Cleared decision on October 25, 2023 after a review of 194 days - an extended review 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: 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 Spineart SA devices

FDA 510(k) Submission Details - K231069

510(k) Number K231069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2023
Decision Date October 25, 2023
Days to Decision 194 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
72d slower than avg
Panel avg: 122d · This submission: 194d
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 706
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K231069.
MASADA Modular Spinal Fixation System
K231694 · Astura Medical · Nov 2023
ANAX™ 5.5 Spinal System
K231737 · Innosys Co., Ltd. · Oct 2023
PressON Spinal Fixation System
K233234 · Nexus Spine, LLC · Oct 2023
Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K232586 · K&J Consulting Corp. · Oct 2023
Ripley Spinal Screw System by SAGICO
K232561 · Sagico VA USA, LLC · Oct 2023
VyLink™ Spinal Screw System
K231744 · Vy Spine, LLC · Oct 2023