(84 days)
No
The summary describes a mechanical spinal fixation system with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a spinal fixation system used to treat various spinal conditions like degenerative disc disease, spondylolisthesis, and deformities, which implies a therapeutic purpose.
No
The device description clearly states it is a "spinal fixation device" used for stabilizing the spine, not for diagnosing medical conditions. Its function is to support and connect, not to detect or identify diseases.
No
The device description explicitly lists hardware components such as "interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties," indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The EBI® SpineLink® II Spinal Fixation System is a physical implantable device used to stabilize the spine. Its intended use is for surgical fixation of the spine in various conditions.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens.
Therefore, based on the provided information, the EBI® SpineLink® II Spinal Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EBI® SpineLink® II Spinal Fixation System is a non-cervical fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anterior/anterolateral fixation.
Product codes
NKB, MNI, MNH, KWQ, KWP
Device Description
The EBT® SpineLink® II Spinal Fixation System is a spinal fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, non-cervical
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)
Mechanical testing comparing the System to predicate systems demonstrates that the device complies with applicable standards and meets all of its functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Spinal Concepts BacFix Spinal Fixation System (K013887), Sofamor Danek CD Spinal System (K964159), Sofamor Danek Townley Pedicle Screw Plating System (K983706)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
031355 NGL 1/2
JUL 2 2 2 2003
510(k) Summary
This 510(k) Summary for the EBI® SpineLink® - II Spinal Fixation System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
- Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Frederic Testa, RAC Telephone: (973) 299-9300, ext.2208
Date prepared: June 30, 2003
| 2. Proprietary Name: | EBI® SpineLink® - II Spinal Fixation System |
|---|---|
| Common Name: | Spinal Fixation Device |
| Classification Names: | Spinal Intervertebral Body Fixation Orthosis |
3. Predicate or legally marketed devices that are substantially equivalent:
- Spinal Concepts BacFix Spinal Fixation System (K013887)
- Sofamor Danek CD Spinal System (K964159)
- Sofamor Danek Townley Pedicle Screw Plating System (K983706) .
-
- Description of the device: The EBT® SpineLink® II Spinal Fixation System is a spinal fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties.
-
- Intended Use: The EBI® SpineLink® II Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system.
1
i70-55 2/2
Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anterior/anterolateral fixation.
-
- Materials: The components of the System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136.
-
- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI® SpineLink® - II Spinal Fixation System and other legally marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials, and function. Mechanical testing comparing the System to predicate systems demonstrates that the device complies with applicable standards and meets all of its functional requirements.
- Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The logo is printed in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2003
Mr. Jon Caparotta, RAC Manager. Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
K031355 Re:
Trade Name: EBI® SpineLink™ II Spinal Fixation System Regulation Number: 21 CFR 888.3070, 888.3060, 888.3050 Regulation Name: Pedicle screw spinal system, Spinal intervertebral body fixation orthosis, Spinal interlaminal fixation orthosis Regulatory Class: III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: April 28, 2003 Received: April 30, 2003
Dear Mr. Caparotta:
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 such 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Jon Caparotta, RAC
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark N. Melkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
Page_1_of_____________________________________________________________________________________________________________________________________________________________________
K031355 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: EBI® SpineLink® - II Spinal Fixation System
Indications For Use:
The EBI® SpineLink® II Spinal Fixation System is a non-cervical fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anterior/anterolateral fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Mark N. Melkerson
Division Sign-O Division of General. Restorative. and Neurological Devices
510(k) Number K031355