(111 days)
The Spinelack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex HV bone cements.
The SpineJack Expansion Kit (herein referred to as "SpineJack") is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and PMMA bone cement is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack, but are sold separately.
This document describes the premarket notification (510(k)) clearance for the SpineJack® Expansion Kit, a medical device used to treat painful osteoporotic vertebral compression fractures. The document outlines the device's indications for use, comparison to predicate devices, and the results of performance and clinical testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text, focusing on the clinical study (SAKOS study) as the primary proof of meeting acceptance criteria:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criteria for the SpineJack device were demonstrated through a non-inferiority study compared to Balloon Kyphoplasty (BKP). The key criteria and results were:
| Acceptance Criteria (Endpoint) | Reported Device Performance (SpineJack vs. BKP) |
|---|---|
| Primary Endpoint: 12-month Responder Rate (Non-Inferiority) | |
| Defined as clinically meaningful improvement in pain and function without pre-specified serious adverse events or reinterventions. | SpineJack: 89.8% responder rate |
| BKP: 87.3% responder rate | |
| Result: p=0.0016. The posterior probability for the final Bayesian analysis (0.09969) successfully met the criteria for study success (posterior probability > 0.987) and demonstrated non-inferiority of the SpineJack to the predicate BKP. | |
| Secondary Endpoint: Additional Composite Endpoint (Superiority) | |
| Defined as the primary endpoint components plus "absence of adjacent level fractures." | SpineJack: 79.7% responder rate |
| BKP: 59.3% responder rate | |
| Result: p |
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”