Vendor/Manufacturer: Choice Spine, LP.
Product/Product Line: Acapella Cervical Spacer System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3080
FDA Regulation Description Classification Name:
Intervertebral Body Fusion Device
FDA Classification Product Code: OVE
FDA Classification Product Code Device Name:
Intervertebral Fusion Device With Integrated Fixation, Cervical
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The Choice Spine Acapella Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
Acapella Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Acapella One implants (K132582).
The material used to construct the anchors is titanium alloy Ti-6Al-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants.
The radiographic markers are composed of tantalum per ASTM F560, which has a long history of safe and effective use in orthopedic implants.
The locking pins are composed of nitinol per ASTM F2063, which has a long history of safe and effective use in orthopedic implants.
The Acapella Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.
Indications for Use:
The Choice Spine Acapella Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Choice Spine Acapella Cervical Spacer System is to be K171489 Page 1 of 2 used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
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