K Number

Device Name

EBI SPINELINK SYSTEM

Manufacturer

ELECTRO-BIOLOGY, INC.

Date Cleared

1999-01-19

(68 days)

Product Code

MNI KWP KWQ MNH

Regulation Number

888.3070

Intended Use

The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine. When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis). In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection. When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.

Device Description

The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links. This submission is to revise the labeling in accordance with the FDA Final Rule dated July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems."

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K964797, K971970, K982908

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical spinal fixation device and does not mention any software, algorithms, or AI/ML capabilities. The submission is focused on labeling revisions for a previously cleared device.

Therapeutic

No
The device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, rather than actively providing therapy.

Diagnostic

The device is a spinal fixation device used for immobilization and stabilization of spinal segments, often as an adjunct to fusion, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "spinal fixation device that uses interconnecting links," which are physical hardware components. The submission is for revising labeling for this hardware system.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
Device Description and Intended Use: The EBI SpineLink™ System is described as a "spinal fixation device" used for "pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine." Its intended use is to "provide immobilization and stabilization of spinal segments, as an adjunct to fusion" in the treatment of various spinal conditions.
Mechanism of Action: The device is a physical implant designed to stabilize the spine. It does not involve the analysis of biological samples.

Therefore, the EBI SpineLink™ System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.

Product codes

MNI, MNH, KWP, KWQ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

noncervical spine; thoracic, lumbar and sacral spine; fifth lumbar - first sacral (L5-S1) vertebral joint; sacrum and ilium; anterolateral vertebral bodies of the lumbar and thoracic spine.

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

experienced spinal surgeons with specific training

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K964797, K971970, K982908

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Kg84027

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI SpineLink™ System is provided as required per Section 513(1)(3) of the Federal Food, Drug and Cosmetic Act.

-------------	------------------------------------------------------------------------	-----------------	-----------------------------------------

Date prepared: December 23, 1998

1. Proprietary Name: EBI SpineLink™ System Spinal Fixation Device Common Name: Spondylolisthesis Spinal Fixation Device System Classification Names: Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis
Predicate or legally marketed devices that are substantially equivalent: 3.

· EBI SpineLink™ System

Description of the device: The EBI SpineLink™ System is a spinal fixation 4. device that uses interconnecting links. This submission is to revise the labeling in accordance with the FDA Final Rule dated July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems."
1. Intended Use: The EBI SpineLink™ System has not changed the Indications for Use or fundamental scientific technology of the previously cleared EBI SpineLink™ System (K964797, K971970, and K982908). The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic . lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

1. Materials: The components of the system are manufactured from Ti-6Al-4V ELI per ASTM F136. The components will be available with and without TiN coating.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI SpineLink™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. The system complies with applicable standards, and meets all of its functional requirements, and meets the required special controls listed below:
- Compliance with material standards. (i)
- Compliance with mechanical testing standards. (ii)
- Compliance with biocompatibility standards. (iii)
- Labeling which contains the following two statements in addition to other (iv) 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 degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown."

The implantation of pedicle screw spinal systems should be "Precaution: 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."

*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 market approval or reclassification and is not intended to be interpreted as an admission of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.))

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 1999

Mr. Jon Caparotta Manager, Regulatory Affairs Electro-Biology, Inc. 100 Interpace Parkway 07054 Parsippany, New Jersey

Re: K984027 EBI SpineLink™ System Regulatory Class: II Product Codes: MNI, MNH, KWP, and KWQ Dated: November 10, 1998 Received: November 12, 1998

Dear Mr. Caparotta:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Page 2 - Mr. Jon Caparotta

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Statement of Indications for Use:

The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

Prescription Use
(Per 21 CFR 801.109)

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Division of General Restorative Devices K984027
510(k) Number