(59 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a spinal implant, with no mention of AI or ML capabilities.
Yes
The device is described as an "intervertebral body fusion device" intended for "spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD)." This clearly indicates its use in treating a medical condition and restoring function, which aligns with the definition of a therapeutic device.
No
The device is described as an intervertebral body fusion device and is intended for spinal fusion procedures, which is a therapeutic intervention, not a diagnostic one. Its function is to facilitate fusion, not to diagnose a condition.
No
The device description clearly states the device is fabricated from titanium and includes physical components like screws and a lock plate, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pro-Link® Ti Stand-Alone Cervical Spacer System is an implantable medical device used in spinal fusion surgery. It is physically placed within the patient's body to provide structural support and promote bone fusion.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae, not by analyzing biological samples.
The provided information describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft.
Product codes
OVE
Device Description
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium (Ti 6Al-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the interbody to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6A1-4V ELI) to prevent screw back out.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
one disc level (C2-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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
Engineering rationales and FEA were provided to demonstrate the substantial equivalency of the Life Spine PRO-LINK Ti Stand-Alone Cervical Spacer System.
Key Metrics
Not Found
Predicate Device(s)
Life Spine PRO-LINK Spacer System (K121151), Life Spine PRO-LINK TITANIUM Spacer System (K160066), Life Spine Plateau-C Titanium (K161127), DePuy Synthes Bengal Cervical Interbody System (K081917)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2018
Life Spine Inc. Mr. Randy Lewis General Manager 13951 S Quality Drive Huntley, Illinois 60142
Re: K180642
Trade/Device Name: Pro-Link® Ti Stand-Alone Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: March 7, 2018 Received: March 12, 2018
Dear Mr. Lewis:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -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) K180642
Device Name
Pro-Link® Ti Stand-Alone Cervical Spacer System
Indications for Use (Describe)
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary Life Spine Pro-Link® Ti Stand-Alone Cervical Spacer
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | April 23rd, 2018 |
| Trade Name: | Pro-Link® Ti Stand-Alone Cervical Spacer |
| Common Name: | Intervertebral body fusion device |
| Classification: | OVE, 21 CFR 888.3080, Class II |
| Primary Predicate: | Life Spine PRO-LINK Spacer System (K121151) |
| Additional Predicates: | Life Spine PRO-LINK TITANIUM Spacer System (K160066)
Life Spine Plateau-C Titanium (K161127)
DePuy Synthes Bengal Cervical Interbody System (K081917) |
Device Description:
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium (Ti 6Al-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the interbody to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6A1-4V ELI) to prevent screw back out.
4
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Pro-Link Ti Stand-Alone Cervical Spacer System components with components from any other system or manufacturer. The PRO-LINK Ti Stand-Alone Cervical Spacer System components should never be reused under any circumstances.
Indications for Use:
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation. The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one-disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft.
Technological Characteristics:
The Life Spine Pro-Link® Ti Stand-Alone Cervical Spacer System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Material:
This submission seeks clearance of a device made from implant grade (Ti-6AL-4V) Titanium alloy according to F136. This is the same material used in the predicate devices.
Performance Data:
Engineering rationales and FEA were provided to demonstrate the substantial equivalency of the Life Spine PRO-LINK Ti Stand-Alone Cervical Spacer System.
Substantial Equivalence:
The Life Spine Pro-Link® Ti Stand-Alone Cervical Spacer System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of the Life Spine Pro-Link® Ti Stand-Alone Cervical Spacer System.