Cleared Traditional

Mini-OSTEO Pedicle Fixation System (K231443) - FDA 510(k) Clearance

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

K231443 · Osteomed Ind?stria E Com?rcio DE Implantes Ltda · Orthopedic device
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Nov 2023
Decision
187d
Days
Class 2
Risk

K231443 is an FDA 510(k) clearance for the Mini-OSTEO Pedicle 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 Osteomed Ind?stria E Com?rcio DE Implantes Ltda (Rio Claro, BR). The FDA issued a Cleared decision on November 21, 2023 after a review of 187 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 Osteomed Ind?stria E Com?rcio DE Implantes Ltda devices

Submission Details

510(k) Number K231443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2023
Decision Date November 21, 2023
Days to Decision 187 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 slower than avg
Panel avg: 122d · This submission: 187d
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 K231443.
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ARx MIS Spinal Screw System
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K232719 · Premia Spine, Ltd. · Nov 2023
MASADA Modular Spinal Fixation System
K231694 · Astura Medical · Nov 2023
ANAX™ 5.5 Spinal System
K231737 · Innosys Co., Ltd. · Oct 2023