(21 days)
IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site
The IGNITE® product combines existing Wright Medical products into a kit configuration: ALLOMATRIX® Injectable Putty (K020895, K041168), and accessory Bone Graft Syringe (K023088) with accessory components which are exempt from 510(k) requirements pursuant to 21 CFR 878.4800. The IGNITE® convenience kit provides surgeons the option of mixing the ALLOMATRIX® powder with sterile water or mixing with autologous bone marrow aspirate (BMA).
This document describes the IGNITE® Kit, a bone void filler. The provided text outlines the device's indications for use, description, materials, and substantial equivalence, along with details regarding its osteoinductivity potential and viral inactivation validation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the IGNITE® Kit are primarily based on its osteoinductive potential and viral inactivation effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoinductivity Potential: | |
| - In vitro assay correlation: | The DBM (Demineralized Bone Matrix) incorporated into IGNITE® Kits showed a correlation coefficient of 0.850 (p0.20 osteoinductivity index versus 33% healing for DBM with |
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.