The Synergy™ Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.

As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the screws fixed or attached to the lumbar and sacral spine; (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.

In addition, the pedicle screw system may also be used 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, and failed previous fusion (pseudarthrosis).

As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:

Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
Idiopathic scoliosis.
Kyphotic deformities of the spine.
Paralytic scoliosis and/or pelvic obliquity.
Lordotic deformities of the spine.
Neuromuscular scoliosis associated with pelvic obliquity.
Vertebral fracture or dislocation.
Tumors.
Spondylolisthesis.
Stenosis.
Pseudarthrosis.
Unsuccessful previous attempts at spinal fusion.

For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy™ hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium

The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

For anterior use, the recommended levels of attachment are: T10 - L3 for the double rod constructs and T5 - L5 for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.

Device Description

The Synergy™ Spinal System components are grouped as follows:

Posterior Application:

Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws, with Hex Nuts and Set Screws. Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.
Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws.
Adjustable and Fixed Transverse Connectors with Set Screws.
Closed and Axial Rod Connectors with Set Screws.
Lateral Connectors with Set Screws.
Rods and Adjustable Length Rods and Set Screws.
Instruments.
Sterilizer case(s).

Anterior Application:

Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
Vertebral Washers.
Fixed Transverse Connectors with Set Screws.
Rods.
Instruments.
Sterilizer case(s).

NOTE: While the Variable Locking Screws and some fasteners (nut and set screws) are used for both the 6.35mm and 4.75mm rod sizes, the remaining components (except for those connector components that are designed to join the two rod sizes) are designed for specific rod diameters.

NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

The Adjustable Length Rod is intended for use as part of either a single or double rod assembly. The Adjustable Length Rod allows for distraction at a central location once the bone anchors have been secured.

AI/ML Overview

The provided text is a 510(k) summary for the Synergy™ Integral Screws, a spinal implant system. It outlines the device's indications for use, description, comparison to predicate devices, and a brief mention of nonclinical tests.

However, the document does not contain the specific acceptance criteria or detailed study results that would allow for a comprehensive report on these criteria. It only states:

"Data regarding the functional performance of the proposed Synergy™ Integral Screws has been generated. Testing included unilateral construct fatigue testing. The test data indicates that the proposed Synergy™ Integral Screws meet or exceed all functional requirements and support its suitability for use."

Therefore, I cannot provide a detailed answer to your request, as the necessary information (acceptance criteria, specific performance metrics, sample sizes, ground truth details, etc.) is not present in the provided document.

To answer your request, I would need a document that includes:

Specific numerical acceptance criteria (e.g., "fatigue strength must exceed X Newtons for Y cycles").
Detailed results of the unilateral construct fatigue testing (e.g., "Tested devices withstood an average of Z Newtons for Q cycles").
Information on the study design and methodology used beyond just "unilateral construct fatigue testing."

Summary

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510(k) SUMMARY

SUBMITTED BY

Prosie Rey-Fessler Director, Quality Assurance and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618

(949) 453-3200

November 9, 1999

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Spinal Intervertebral Body Fixation Orthosis Common/Usual Name: Posterior Spine Implants Product Classification: Class II Proprietary Name: Synergy™ Integral Screws

PREDICATE DEVICE

The predicate device is the Zimmer Harrington® Spinal System and the INTERPORE CROSS International Synergy™ Spinal System.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 8807.92.

INDICATIONS-FOR-USE

The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.

As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint; (b) who are having the screws fixed or attached to the lumbar and sacral spine; (c) who are receiving fusions using autogenous bone graft only; and (d) who are

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1-193565

having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.

In addition, the pedicle screw system may also be used 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, spinal tumor, and failed previous fusion (pseudarthrosis).

As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
1. Idiopathic scoliosis.
1. Kyphotic deformities of the spine.
1. Paralytic scoliosis and/or pelvic obliquity.
1. Lordotic deformities of the spine.
1. Neuromuscular scoliosis associated with pelvic obliquity.
1. Vertebral fracture or dislocation.
1. Tumors.
1. Spondylolisthesis.
1. Stenosis.
1. Pseudarthrosis.
1. Unsuccessful previous attempts at spinal fusion.

For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.

The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

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DEVICE DESCRIPTION

The Synergy™ Spinal System components are grouped as follows:

Posterior Application:

1. Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws, with Hex Nuts and Set Screws. Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.
1. Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws.
1. Adjustable and Fixed Transverse Connectors with Set Screws.
1. Closed and Axial Rod Connectors with Set Screws.
1. Lateral Connectors with Set Screws.
1. Rods and Adjustable Length Rods and Set Screws.
1. Instruments.
1. Sterilizer case(s).

Anterior Application:

1. Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
1. Vertebral Washers.
1. Fixed Transverse Connectors with Set Screws.
1. Rods.
1. Instruments.
1. Sterilizer case(s).

NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

COMPARISON TO THE PREDICATE DEVICE

The preamendment Harrington System and the Interpore Cross Synergy System are comparable posterior approach systems. Both are used to treat similar or the same conditions, have essentially the same precautions and contraindications for use, and have equivalent potential for complications for the risk of use. In addition, they all represent a

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long standing, basic design concept and in terms of safety and effectiveness, differ only in minor details. Based on the basic design concept, the use of established well-known materials, feature comparisons, mechanical testing, indications for use, surgical approach, preproduction quality assurance planning and engineering analysis, Interpore Cross International believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to existing legally marketed posterior spine system.

DISCUSSION OF NONCLINICAL TESTS

Data regarding the functional performance of the proposed Synergy™ Integral Screws has been generated. Testing included unilateral construct fatigue testing. The test data indicates that the proposed Synergy™ Integral Screws meet or exceed all functional requirements and support its suitability for use.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 1999

Ms. Prosie Rey-Fessler Director, Quality Assurance and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

K993808 Re: Synergy™ Spinal System Trade Name: Requlatory Class: II Product Codes: MNH, KWQ, and MNI Dated: November 9, 1999 Received: November 10, 1999

Dear Ms. Rey-Fessler:

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 reguirements 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 requlations 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.

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Page 2 - Ms. Prosie Rey-Fessler

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,

Neil R.P. Ogden

James E. Dil lard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K993808

Synergy™ Integral Screws Device Name:

Indications-For-Use:

The implants are attached to the spine posteriorly by means of hooks and/or screws ioined with rods and anteriorly by means of vertebral screws joined with rods.

(continued)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE

(Division Sign-Off)
Division of General Restorative Devices
510(kl Number K993808

Prescription Use
(PER 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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510(k) Number (if known): ヒ993808

Synergy™ Integral Screws Device Name:

Indications-For-Use (cont'd):

As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
1. Idiopathic scoliosis.
1. Kyphotic deformities of the spine.
1. Paralytic scoliosis and/or pelvic obliquity.
1. Lordotic deformities of the spine.
1. Neuromuscular scoliosis associated with pelvic obliquity.
1. Vertebral fracture or dislocation.
1. Tumors.
1. Spondylolisthesis.
1. Stenosis.
1. Pseudarthrosis.
1. Unsuccessful previous attempts at spinal fusion.

The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

Regulation Number and Section

N/A