← Back to catalogue

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGu…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K143159

by SpineGuard.S.A

Identifiers

510(k) Number
K143159 FDA 510(k)
FDA Product Code
PDQ FDA 510(k)
Models / Variants
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle FDA 510(k)EUDAMED
PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.1820 FDA 510(k)
Regulation Number
874.1820 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PediGuard system comprises cannulated and non-cannulated pedicle screws and needles designed for spinal and skeletal implant placement. These instruments are intended for use in orthopedic and neurosurgical procedures to assist in accurate screw insertion, particularly in pediatric and small-bone applications. The cannulated needles facilitate guidewire passage, while the tri-tip and curved designs enhance precision in challenging anatomical areas.

The PediGuard instruments are supplied as reusable medical devices and are intended for use in sterile operating room environments. They are classified as Class II devices under FDA regulations and comply with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Europe. Sizes and configurations include Ø2.5mm, Ø3.2mm, Ø4.0mm, and curved variants, with specific lengths such as the 120mm cannulated needle. Authorized under FDA 510(k) clearance (K143159) and regulatory filings in the EU, these devices are intended for use in Ear, Nose, and Throat (ENT) and orthopedic procedures.

Frequently asked questions

Are these instruments designed for single-use or can they be reused in multiple procedures?

The PediGuard system instruments are explicitly labeled as reusable medical devices. They are intended for use in sterile operating room environments and must be properly cleaned, sterilized, and maintained between procedures to ensure safety and performance. Reuse is a key aspect of their design, as noted in the device description.

What are the key differences between the cannulated and non-cannulated PediGuard needles, and how do they benefit clinical use?

The cannulated PediGuard needles (e.g., Cannulated PediGuard Needle#1, Cannulated PediGuard Needle 120mm) are designed with a hollow interior to facilitate the passage of guidewires, which improves precision during screw placement—especially in pediatric or small-bone applications. In contrast, the non-cannulated variants (e.g., PediGuard Tri Tip Ø2.5mm) lack this feature but may offer alternative advantages like enhanced rigidity or tactile feedback. The cannulated design is particularly useful when guidewire-assisted techniques are preferred for accuracy.

What sizes and configurations are available for the PediGuard Tri Tip and curved variants, and how might they be selected for a procedure?

The PediGuard Tri Tip variants come in three diameters: Ø4.0mm, Ø3.2mm, and Ø2.5mm, while the curved versions (PediGuard Curv and PediGuard Curv XS) are designed for navigating challenging anatomical areas. The Ø2.5mm XS is likely a smaller, extra-small variant for delicate or pediatric cases. Selection depends on the patient’s anatomy, screw size, and procedural requirements—smaller diameters (e.g., Ø2.5mm) are typically used for pediatric or minimally invasive applications, while larger diameters (e.g., Ø4.0mm) may suit adult orthopedic or ENT procedures where stability is critical.

How are these instruments regulated, and what does the FDA 510(k) clearance (K143159) indicate about their intended use?

The PediGuard system holds FDA 510(k) clearance (K143159) under the Ear, Nose, and Throat (ENT) advisory committee, with a classification as Class II devices. This clearance indicates the manufacturer has demonstrated that the instruments are substantially equivalent to a legally marketed predicate device for use in ENT and orthopedic procedures, particularly for spinal and skeletal implant placement. The regulatory filings also align with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU, ensuring compliance across markets.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
SpineGuard.S.A
FDA Applicant
Spineguard S.A.

Sources (2)

  • FDA 510(k) K143159 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026