(214 days)
No
The summary describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a surgical implant intended for spinal fusion procedures to treat degenerative disc disease, directly addressing a health condition.
No
This device is a cervical spacer system intended for spinal fusion procedures, acting as an intervertebral body fusion device. Its purpose is treatment (fusion), not diagnosis.
No
The device description clearly describes a physical implant (cervical spacer system) made of titanium, intended for surgical implantation. It includes details about its size, shape, and components like screws and a lock plate. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Pro-Link Cervical Spacer System is an implantable device designed to be surgically placed in the spine to promote fusion. It is a physical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Pro-Link Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.
The Pro-Link 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 Cervical Spacer System is intended to serve as a stand-alone intervertebral body fusion device. The system is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. The implant is hollow to permit packing with autogenous bone graft to help promote fusion. It includes two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) to provide internal fixation while a titanium lock plate (Ti 6Al-4V ELI) prevents screw back out.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1 (cervical spine)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and dynamic torsion and compression testing in accordance with ASTM F2077 was presented to demonstrate the substantial equivalency of the Pro-Link Cervical Spacer System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Small Plateau (Plateau-C) Spacer System (K111835), LDR Spine Cervical Interbody Fusion System (K113559), Globus Coalition (K083389), RSB Spine Interplate (K081194)
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
1121151
page 1 of 2
NOV 1 6 2012 Pro-Link Cervical Spacer System Submitted Bv: Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates. IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118 Randy Lewis 510(k) Contact: RA/QA Manager Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118 April 13th, 2012 Date Prepared: Trade Name: Pro-Link Cervical Spacer Classification: OVE, 21 CFR 888.3080, Class II, Intervertebral Body Fusion Device Predicate Device: The Small Plateau (Plateau-C) Spacer System (K111835) LDR Spine Cervical Interbody Fusion System (K113559) Globus Coalition (K083389) RSB Spine Interplate (K081194)
510(k) Summary
Device Description:
The PRO-LINK Cervical Spacer System is intended to serve as a stand-alone intervertebral body fusion device. The system is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. The implant is hollow to permit packing with autogenous bone graft to help promote fusion. It includes two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) to provide internal fixation while a titanium lock plate (Ti 6Al-4V ELI) prevents screw back out.
Intended Use of the Device:
The Pro-Link Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.
The Pro-Link 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.
1
KISI 151
Technological Characteristics:
The Pro-Link Cervical Spacer System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.
Material:
The PRO-LINK Cervical Spacer System is manufactured from implantable grade PEEK-Optima LT1 per ASTM F2026, incorporates tantalum markers per ASTM F560, and implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136.
Performance Data:
Static and dynamic torsion and compression testing in accordance with ASTM F2077 was presented to demonstrate the substantial equivalency of the Pro-Link Cervical Spacer System.
Conclusion:
The Pro-Link Cervical Spacer System was shown to be substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 16, 2012
Life Spine, Incorporated % Mr. Randy Lewis Regulatory Affairs and Quality Assurance Manager 2401 West Hassell Road, Suite 1535 Hoffman Estates. Illinois 60169
Re: K121151
Trade/Device Name: Pro-Link Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: OVE Dated: October 11, 2012 Received: October 11, 2012
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 (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.
3
Page 2 - Mr. Randy Lewis
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Laurence D. Coyne
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K 12/15/
510(k) number (if known):
Device Name: Pro-Link Cervical Spacer System
The Pro-Link Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.
The Pro-Link 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.
Prescription Use x (Part 21 CFR 801 Subpart D) And/Or
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Carl-Roffi
(Division Sign-Off Division of Orthopenic Device 12-115 510(k) Number