(132 days)
Not Found
Not Found
No
The summary describes a passive implantable device made of PEEK, with no mention of software, algorithms, or any features indicative of AI/ML.
No.
The device replaces bone and acts as a fusion device, which are structural and mechanical functions, not therapeutic.
No
The device description and intended use indicate that the X-spine Calix System is an implantable medical device used for spinal fusion and vertebral body replacement, not for diagnosing medical conditions.
No
The device description clearly states it is a "generally box-shaped device" made from "polyetheretherketone (Invibio PEEK-Optima)", indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Calix system is a physical implant made of PEEK material. Its intended use is to replace or fuse vertebral bodies in the spine during surgical procedures. This is a surgical implant, not a diagnostic test performed on a sample outside the body.
The information provided focuses on the device's physical characteristics, surgical application, and mechanical performance, all of which are consistent with a surgical implant and not an IVD.
N/A
Intended Use / Indications for Use
When used as a vertebral body replacement, the X-spine Calix System is intended for use in the thoracic and/or thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft.
When.used as an intervertebral body fusion device, the X-spine Calix System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Calix intervertebral body fusion device.
For all indications, this device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical, thoracic or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Product codes
ODP, MQP
Device Description
The Calix system is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device is made from polyetheretherketone (Invibio PEEK-Optima).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or thoracolumbar spine (TI-L5), cervical spine (C3-C7)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Mechanical testing indicates that the Calix system is capable of performing in accordance with its intended use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
APR 2 0 2009
510(k) Summary
ADMINISTRATIVE INFORMATION
Manufacturer Name: X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342
Telephone (937) 847-8400 FAX (937) 847-8410
Official Contact:
David Kirschman, MD Chief Medical Officer
DEVICE NAME
| Trade/Proprietary Name: | Calix ™™ Spinal Implant System |
|---|---|
| Common Name: | Intervertebral body fusion device |
ESTABLISHMENT REGISTRATION NUMBER
X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X spine Systems, Inc. is 9063903.
DEVICE CLASSIFICATION
FDA has classified intervertebral fusion device with bone graft, cervical as a Class II device (21 CFR 888.3080). The product code for intervertebral fusion device with bone graft, cervical is ODP. Additionally, the FDA has classified spinal vertebral body replacement device as a Class II device (21 CFR 888.3060). The product code for spinal vertebral body replacement device is MQP. These device classifications are reviewed by the Orthopedic Devices Branch.
1
INTENDED USE
When used as a vertebral body replacement, the X-spine Calix System is intended for use in the thoracic and/or thoracolumbar spine (TI-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft.
When used as an intervertebral body fusion device, the X-spine Calix System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Calix intervertebral body fusion device.
For all indications, this device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical, thoracic or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
DEVICE DESCRIPTION
The Calix system is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device is made from polyetheretherketone (Invibio PEEK-Optima).
EQUIVALENCE TO MARKETED PRODUCT
X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Calix Spinal Implant System is substantially equivalent in indications and design principles to predicate devices.
PERFORMANCE DATA
Mechanical testing indicates that the Calix system is capable of performing in accordance with its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of thick, black lines. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
X-Spine Systems, Inc. % David Kirschman, M.D. 452 Alexandersville Road Miamisburg, Ohio 45342
APR 2 0 2009
Re: K083637
Trade/Device Name: Calix Spinal Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: February 2, 2009 Received: April 8, 2009
Dear Dr. Kirschman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - David Kirschman, M.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B-mllare-Bregnd
for
Mark N. Melkerson Director Division of General, Restorative, And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KUR5651
Page 1 of 1
Attachment A Indications for Use - REVISION 2
KD 83637 510(k) Number (if known):
Device Name: Calix™ Spinal Implant System
Indications for Use:
When used as a vertebral body replacement, the X-spine Calix System is intended for use in the thoracic and/or thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft.
When.used as an intervertebral body fusion device, the X-spine Calix System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Calix intervertebral body fusion device.
For all indications, this device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical, thoracic or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
thelnie Breen for mxv
(Division Sign-Off)
510(k) Number K083637
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