When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
spondylolisthesis
fracture
spinal stenosis
deformities (i.e. scoliosis, kyphosis, lordosis)
tumors
failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
receive fusions using autogenous bone graft only;
have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
have the device removed after the development of a solid fusion.

In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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:

Degenerative spondylolisthesis with objective evidence of neurologic impairment
fracture
dislocation
scoliosis
kyphosis
spinal tumor
failed previous fusion (pseudoarthrosis)

Device Description

The PI.US Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and The 11100 Proceed be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.

AI/ML Overview

The document is a 510(k) summary for the PLUS™ Pivot Link Universal System for spinal instrumentation. This type of submission is for medical devices, not AI/ML-driven software, and therefore the concepts of acceptance criteria related to algorithmic performance, ground truth, expert adjudication, or MRMC studies do not apply.

The basis of substantial equivalence for this device is primarily through mechanical testing which demonstrates its equivalence in terms of design, material, and intended use to other FDA-cleared spinal instrumentation systems.

Therefore, I cannot provide the requested information as it pertains to an entirely different type of device evaluation than what is described in the provided text.

Summary

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JAN 2 7 2004

Image /page/0/Picture/1 description: The image shows the SpineVision logo, which includes a stylized black triangle pointing downwards above the word "SpineVision" in a bold, sans-serif font. To the top left of the logo is the text "K033508", and to the top right is the text "1 of 2". The logo is clean and modern, suggesting a focus on spinal health and technology.

Spine systems for specialists

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	SpineVision, Inc.3003 Summit Blvd., Suite 1400Atlanta, GA 30319Phone: 404-460-5077
510(K) CONTACT:	Lynnette WhitakerVice President, Regulatory Affairs574-269-9776
TRADE NAME:	PLUS™ Pivot Link Universal System
COMMON NAME:	Rod, Hook, and Screw Spinal Instrumentation
CLASSIFICATION:	888.3050 Spinal Interlaminal Fixation Orthosis888.3070 Pedicle Screw Spinal System888.3060 Spinal Intervertebral Body Fixation Orthosis
DEVICE PRODUCT CODE:	Product code: 87 KWP, MNH, MNI, KWQ
SUBSTANTIALLY EQUIVALENT DEVICES:	PLUS Pivot Link Spinal System, SpineVision, Inc.MOSS Miami Spinal System, DePuy Motech AcroMedUniversal Spine System, Synthes

DEVICE DESCRIPTION AND INTENDED USE:

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K03350X

INDICATIONS FOR USE

When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

Not Ennt On. Jose disease (discogenic back pain with degencration of the disc . confirmed by history and radiographic studies)
spondylolisthesis �
fracture ●
spinal stenosis .
deformities (i.e. scoliosis, kyphosis, lordosis) ◆
tumors .
failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
receive fusions using autogenous bone graft only; .
have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and .
have the device removed after the development of a solid fusion. .

Degenerative spondylolisthesis with objective evidence of neurologic impairment .
fracture .
dislocation .
scoliosis .
kyphosis ●
spinal tumor .
failed previous fusion (pscudoarthrosis) .

BASIS OF SUBSTANTIAL EQUIVALENCE:

DADIN OF SUDS PIVOL Link Universal System are identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA for spinal use. Mcchanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2004

Ms. Lynnette Whitaker Vice President, Regulatory Affairs SpineVision, Inc. 3003 Summit Boulevard, Suite 1400 Atlanta, Georgia 30319

Re: K033508

Trade/Device Name: PLUS™ Pivot Link Universal System, Additional Components Regulation Number: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis. Spinal intervertebral body fixation orthosis, Pedicle screw spinal system. Regulatory Class: II

Product Code: MNI, MNH, KWQ, KWP Dated: November 6, 2003 Received: November 6, 2003

Dear Ms. Whitaker:

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. 1)rug. 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 max 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 sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act): 21 CVR 1000-1050.

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Page 2 - Ms. Lynnette Whitaker

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. Millman

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

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Image /page/4/Picture/0 description: The image contains two sets of characters. On the left, the characters appear to be '1061'. On the right, there is a colon followed by '033508'. The characters are black against a white background.

PLUS™ Pivot Link Universal System, Additional Components Device Name:

Indications for Use:

When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history . and radiographic studies)
spondylolisthesis .
fracture .
� spinal stenosis
deformities (i.e. scoliosis, kyphosis, lordosis) .
. tumors
failed previous fusion (pseudoarthrosis) .

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
receive fusions using autogenous bone graft only; .
have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and .
have the device removed after the development of a solid fusion. ●

Degenerative spondylolisthesis with objective evidence of neurologic impairment t
fracture .
. dislocation
scoliosis .
kyphosis ●
spinal tumor .
. failed previous fusion (pseudoarthrosis)

Concurrence of CDRH, Office of Device Evaluatio

Prescription Use

OR
(Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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.