Identifiers
- 510(k) Number
- K133053 FDA 510(k)
- FDA Product Code
- MAX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Milestone Spinal System is a spinal fusion device designed for lumbar interbody fusion surgeries. It consists of INVIBIO PEEK-OPTIMA LTI lumbar cages of varying lengths and heights, intended to provide structural support and correct spinal alignment between lumbar or lumbosacral vertebral bodies. These cages are classified as an orthopedic implant under product code MAX, serving as an interbody spacer to facilitate fusion.
The device is supplied as a set of reusable surgical instruments and single-use lumbar cages, with sterility maintained through terminal sterilization. It is intended for use in operating rooms equipped for spinal surgery and must comply with MRI safety standards for the materials used. The system is authorized for use in the United States under an FDA 510(k) clearance (K133053) and is classified as a Class II medical device. Storage and handling follow standard orthopedic implant protocols to preserve sterility and functionality.
Frequently asked questions
What is the Milestone Spinal System used for?
The Milestone Spinal System is designed specifically for lumbar interbody fusion surgeries. It provides structural support and helps correct spinal alignment between lumbar or lumbosacral vertebral bodies by acting as an interbody spacer. This promotes spinal fusion, which is essential for stabilizing the spine in patients with degenerative disc disease, spinal stenosis, or other conditions requiring surgical intervention.
How is the Milestone Spinal System supplied, and what does the packaging include?
The Milestone Spinal System is supplied as a combination of single-use lumbar cages (made from INVIBIO PEEK-OPTIMA LTI material) and reusable surgical instruments. The lumbar cages come in varying lengths and heights to accommodate different anatomical needs, while the instruments are designed for precise surgical handling. Sterility is maintained through terminal sterilization, ensuring safety for use in the operating room.
Are the lumbar cages in the Milestone Spinal System single-use or reusable?
The lumbar cages included in the Milestone Spinal System are intended for single-use only. This design choice ensures sterility and reduces the risk of cross-contamination between patients. The reusable components are limited to the surgical instruments, which are sterilized and reused for subsequent procedures.
What materials are the lumbar cages made from, and are they MRI-safe?
The lumbar cages in the Milestone Spinal System are manufactured from INVIBIO PEEK-OPTIMA LTI, a high-performance polymer known for its biocompatibility and mechanical properties. These materials are also compliant with MRI safety standards, meaning they can be safely used in patients who require MRI imaging post-surgery without causing artifacts or interference.
How should the Milestone Spinal System be stored to maintain sterility and functionality?
The Milestone Spinal System should be stored according to standard orthopedic implant protocols to preserve sterility and functionality. Single-use lumbar cages should remain in their original, sealed packaging until immediately before use. Reusable surgical instruments must be cleaned, inspected, and sterilized between procedures following the manufacturer’s guidelines. Proper storage conditions, such as avoiding extreme temperatures or moisture, are critical to maintaining the integrity of both the cages and instruments.
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: K133053 FDA 510 (k) - MILESTONE SPINAL SYSTEM, MILESTONE SPINAL SYSTEM (K133053) — FDA 510(k) | Innolitics, Milestone Systems | Global leading video management software provider, PDF JUL 15 2014 - Food and Drug Administration, K133053 FDA 510 (k) - MILESTONE 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 | K133053 | Class II | Active |
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Manufacturer
- Manufacturer
- Weigao Orthopaedic Device Co., Ltd.
Sources (1)
- FDA 510(k) K133053 24 fields · synced Oct 1, 2026