(85 days)
Not Found
No
The summary describes a physical implant (intervertebral body fusion cage) and its materials, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
Yes
The device is used for the treatment of cervical degenerative disc disease, which involves addressing a medical condition to improve health, fitting the definition of a therapeutic device.
No
This device is an intervertebral body fusion cage intended for treatment of degenerative disc disease, not for diagnosis. It is a surgical implant designed to facilitate fusion.
No
The device description clearly states it is a physical intervertebral body fusion cage made of PEEK and titanium, with screws and X-ray marker wires. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "intervertebral body fusion cage" used for the treatment of cervical degenerative disc disease. This is a surgical implant used in vivo (within the body) to facilitate bone fusion.
- Device Description: The description details a physical implant made of PEEK and titanium, designed to be inserted into the disc space.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® Ti are intended to be used at one level.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The STALIF C® Ti is identical to this design with a titanium plasma spray coating on the device endplates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to T1 (cervical spine)
Indicated Patient Age Range
skeletally mature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A comprehensive, clinical literature review and PearlDiver reimbursement data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the STALIF C. No new mechanical tests were performed since there were no design changes to the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines representing hair or ribbons. The profiles are stacked slightly offset from each other. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
Centinel Spine, Incorporated % Mr. Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K142079
Trade/Device Name: STALIF C® and STALIF C® Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: July 30, 2014 Received: July 31, 2014
Dear Mr. Eggleton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142079
Device Name STALIF C® and STALIF C® Ti
Indications for Use (Describe)
The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® Ti are intended to be used at one level.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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4. 510(k) Summary
| Device Trade Name: | STALIF C® and STALIF C® Ti |
|---|---|
| Manufacturer: | Centinel Spine, Inc. |
| 900 Airport Road, Suite 3B | |
| West Chester, PA 19380 | |
| Contact: | Mr. John Parry |
| Development Manager | |
| Phone: (484) 887.8813 | |
| Prepared by: | Mr. Justin Eggleton |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| jeggleton@mcra.com | |
| Date Prepared: | July 30, 2014 |
| Classifications: | 21 CFR §888.3080, Intervertebral Body Fusion Device |
| Class: | II |
| Product Codes: | OVE |
Indications For Use:
The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® and STALIF C® Ti are intended to be used at one level.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
Summary of Technological Characteristics:
STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate
4
with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The STALIF C® Ti is identical to this design with a titanium plasma spray coating on the device endplates.
The purpose of the subject 510(k) was to expand the indications to include use with allograft.
Predicate Device:
The subject STALIF C® and STALIF C® Ti intervertebral body fusion devices are substantially equivalent to predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K130177) with respect to indications, design, function, and materials.
Substantial Equivalence:
STALIF C®, STALIF C® Ti and predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM are similar in design, material, and indicated use, and are both cleared devices. They do differ in that the ANATOMIC PEEK™ is indicated for use with allogenic bone graft. A comprehensive, clinical literature review has been conducted to investigate the risks and benefits associated with using allogenic bone graft with the STALIF C". The clinical literature suggests that there is a positive benefit associated with allograft with minimal risk.
Performance Testing:
A comprehensive, clinical literature review and PearlDiver reimbursement data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the STALIF C. No new mechanical tests were performed since there were no design changes to the device.
Conclusion:
The Centinel Spine STALIF C® and STALIF C® Ti have been modified to expand the indications to permit use with allograft. The 510(k) demonstrates substantial equivalence to predicate devices.