Orthobiom Spinal System (K071668)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071668 FDA 510(k)
- FDA Product Code
- MNI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Orthobiom Spinal System is a posterior, non-cervical pedicle screw system designed for spinal fixation. It is classified as an orthopedic device under the FDA’s product code MNI, intended for surgical correction, stabilization, adjustment, and fixation of the scoliotic spine in pediatric patients. The system is engineered to provide structural support to the spine while facilitating alignment during surgical intervention. It is specifically intended for use in non-cervical regions of the spine.
The Orthobiom Spinal System is supplied as a reusable surgical implant and is intended for single-patient use per procedure. It requires use with bone graft material to achieve fixation. The device has received FDA 510(k) clearance under a Traditional review pathway, with a clearance date of July 2, 2008. No specific sterility or MRI safety information is provided in the available data, though standard surgical precautions apply during use.
Frequently asked questions
What is the Orthobiom Spinal System used for?
The Orthobiom Spinal System is a posterior pedicle screw device intended for surgical correction, stabilization, and fixation of the scoliotic spine in pediatric patients. It is specifically designed for non-cervical spinal regions to provide structural support and facilitate alignment during surgery. The system is engineered to address spinal deformities by securing vertebrae in place while allowing gradual adjustment as the patient grows.
How is the Orthobiom Spinal System supplied and intended for use?
The Orthobiom Spinal System is supplied as a reusable surgical implant, meaning it can be used across multiple procedures but must be dedicated to a single patient per surgery. It requires the use of bone graft material to achieve proper fixation and stability. This design ensures that each patient receives a sterile, dedicated system while maintaining cost-efficiency for healthcare providers.
Is the Orthobiom Spinal System single-use or reusable?
The Orthobiom Spinal System is reusable in the sense that it can be used across multiple surgical procedures. However, it is intended for single-patient use per procedure to maintain sterility and prevent cross-contamination. This means the system must be dedicated to one patient at a time, even if it is reused in subsequent surgeries for other patients.
Does the Orthobiom Spinal System come with specific sterility or MRI safety information?
The available data for the Orthobiom Spinal System does not provide explicit details on sterility assurance or MRI safety. As with all surgical implants, standard surgical precautions should be followed to ensure sterility during use. For MRI safety, clinicians should consult the latest guidelines or manufacturer documentation, as compatibility with MRI machines is not confirmed in the provided information.
What regulatory pathway was followed for the Orthobiom Spinal System?
The Orthobiom Spinal System received FDA 510(k) clearance under the Traditional review pathway, which is the standard process for demonstrating substantial equivalence to a predicate device already on the market. The clearance was granted on July 2, 2008, confirming that the device meets regulatory standards for spinal fixation in pediatric scoliosis. This pathway ensures that the device’s safety and effectiveness have been evaluated against a previously approved, similar product.
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. Sources consulted: Home - Paradigm Spine, ORTHOBIOM SPINAL SYSTEM (K071668) — FDA 510(k) | Innolitics, Field Safety Notices about Orthobiom Spinal System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071668 | Class II | Active |
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Manufacturer
- Manufacturer
- Paradigm Spine
Sources (1)
- FDA 510(k) K071668 24 fields · synced Oct 1, 2026