PD-32-301: Providence Medical ALLY Titanium Spinal Fixation Screw

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Providence Medical ALLY Bone Screw – PD-32-301 – Titanium Fixation Screw with Snap-Off Handle

The Providence Medical ALLY® Bone Screw (PD-32-301) is a single-use titanium fixation screw designed to provide supplemental stabilization in spinal fusion procedures. It features an integrated snap-off handle that simplifies insertion and eliminates the need for separate instrumentation. The screw is delivered pre-assembled and sterile, offering procedural efficiency and consistent deployment during surgery.

Product Code: PD-32-301

• Material: Titanium alloy (Ti-6Al-4V ELI)
• Threading: Partially or fully threaded options
• Indications: Bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fixation
• Handle: Pre-attached disposable handle with snap-off release feature

Contents

• One sterile, single-use titanium bone screw
• Pre-attached disposable insertion handle

Features

• Snap-off handle for streamlined deployment
• Designed for supplemental fixation in spinal and orthopedic procedures

Sterilization

• Device Packaged as Sterile: Yes
• Requires Sterilization Prior to Use: No
• Single-Use, Disposable

Additional Details

• Brand: Providence Medical Technology
• Category: Spinal Implants
• Type: Bone Screw, Implant
• FDA Product Code: HWC
• FDA Product Code Name: Screw, Fixation, Bone
• GMDN Term Code: 58109
• GMDN Term Name: Implantable cervical facet joint distractor
• GMDN Term Definition: A non-powered wedge-shaped device intended to be inserted within a cervical facet joint (spinal joint), i.e., intra-facet, for joint distraction; the distraction is intended to facilitate nerve root decompression and stabilization of the spine in the treatment of various spinal conditions. It is typically fenestrated or barbed and may incorporate a screw to expand to shape and/or to provide fixation within the joint and cervical spine stabilization. It typically includes single-use instruments (e.g., chisels, rasps) for implantation.

INDICATIONS FOR USE
The ALLY™ Bone Screw is intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

CONTRAINDICATIONS:

• The ALLY™ Bone Screw should not be used in any of the following instances:
• Patients with active or suspected infection
• Physiologically or psychologically inadequate patient
• Inadequate skin, bone or neurovascular status
• Irreparable tendon system
• Possibility of conservative treatment
• Growing patients with open epiphyses

Providence Medical Technology specializes in innovative solutions for cervical spine disorders, with a focus on minimally invasive, posterior approaches. Their CORUS™ Spinal System is a key component of their PACS™ (Posterior Cervical Stabilization) platform, offering a comprehensive set of implants and instruments for posterior cervical fusion. Designed to treat conditions like cervical radiculopathy and myelopathy, the CORUS system enables tissue-sparing procedures that promote stability and fusion with reduced surgical disruption. Combined with their proprietary DTRAX® implants, Providence delivers a streamlined, patient-focused approach to cervical spine care.