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, 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 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 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 (nuts 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 describes a 510(k) premarket notification for the Synergy™ Ti Fenestrated Integral™ Open Screws spinal implants and discusses their substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.

Instead, the "nonclinical tests" discussed refer to mechanical testing to ensure the physical properties and strength of the implant.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific acceptance criteria and performance metrics (e.g., sensitivity, specificity, accuracy) are NOT mentioned for the device itself in a clinical context. The "performance" discussed is related to the mechanical integrity of the implant.

Acceptance Criteria (Type of Test)	Reported Device Performance
Functional Requirements (Mechanical Testing)	"Mechanical testing indicates that the Synergy Ti Fenestrated Integral Open Screws meet or exceed all functional requirements and support their suitability for use." (Qualitative statement)

2. Sample Size Used for the Test Set and Data Provenance

Not applicable to a clinical or AI performance study. The "test set" in this context refers to the samples used for mechanical testing. The sample size for these mechanical tests is not specified.
The data provenance (country of origin, retrospective/prospective) is not relevant as this is a mechanical engineering evaluation, not a clinical data study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. "Ground truth" in the context of clinical performance or AI evaluation typically refers to expert diagnoses or pathological findings. For mechanical testing, the "ground truth" is established by engineering standards and test protocols, not human experts making diagnostic judgments on a test set.

4. Adjudication Method for the Test Set

Not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts in clinical studies, which is not what was performed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence through mechanical testing and comparison of design, materials, indications for use, and surgical approach to a predicate device. There is no mention of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study (algorithm only) was done. This submission is for a physical medical device (spinal implant), not an algorithm or AI system.

7. Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be the established engineering standards and requirements for spinal implants. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for evaluating the device's mechanical performance.

8. Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device, so there is no concept of a "training set" in this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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SEP 1 2 2001

510(k) SUMMARY

K012871

SUBMITTED BY

Lynn M. Rodarti Manager, Regulatory and Clinical Affairs INTERPORE CROSS International 181 Technology Drive Irvine, California 92618

(949) 453-3200

August 24, 2001

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Spinal Intervertebral Body Fixation Orthosis Common/Usual Name: Anterior and Posterior Spinal Implants Product Classification: Class II Proprietary Name: Synergy™ Ti Fenestrated Integral™ Open Screws

PREDICATE DEVICE

The predicate device is the INTERPORE CROSS International Synergy Integral Open Screw for anterior and posterior use, which was previously cleared under 510(k)'s K934429 and K940631.

INDICATIONS-FOR-USE

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.

{1}------------------------------------------------

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.

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 Nuts and Set Screws. Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.

{2}------------------------------------------------

Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws. 2.
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 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 Synergy Ti Fenestrated Integral Open Screw spinal implants are technologically substantially equivalent to the previously cleared Synergy Integral Open Screws. Both implants are used to treat the same conditions, have the same precautions and contraindications for use, and have equivalent potential for complications associated with the risk of use. In addition, they both represent a 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 the Synergy Ti Fenestrated Integral Open Screws are substantially equivalent to existing legally marketed spinal implants.

DISCUSSION OF NONCLINICAL TESTS

Data regarding the functional performance of the Synergy Ti Fenestrated Integral Open Screws has been generated. Mechanical testing indicates that the Synergy Ti Fenestrated

{3}------------------------------------------------

Integral Open Screws meet or exceed all functional requirements and support their suitability for use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

SEP 1 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynn Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross 181 Technology Drive Irvine, California 92618-2402

Re: K012871

Synergy™ Spinal System - Synergy Ti Fenestrated Integral Open Screws Regulation Numbers: 888.3050, 888.3060, and 888.3070 Regulation Names: Spinal Interlaminal Fixation Orthosis; Spinal Intervertebral Body Fixation Orthosis; Spondylolisthesis Spinal Fixation Device System; and Pedicle Screw Spinal System Regulatory Class: II Product Codes: KWP; KWQ; MNI; and MNH Dated: August 24, 2001 Received: August 27, 2001

Dear Ms. Rodarti:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your beceremined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal 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 I ho general ocharity 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 I loase oe actived that I Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I valuated and strequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.

{5}------------------------------------------------

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 nonicate 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 If you desire specific diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (201) 591 1059. Tradition at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respensional 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,

Swiackon s

Image /page/5/Picture/5 description: The image shows a simple, hand-drawn sketch of a shape resembling a stylized letter or symbol. The shape consists of a curved line that starts from the bottom left, loops upwards and to the right, and then curves back down. The bottom part of the shape has a small, angular extension, giving it a slightly abstract appearance.

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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510(k) Number (if known): 〈〈○)287/

Synergy Ti Fenestrated Integral Open Screws Device Name:

Indications-For-Use:

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.

(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 and NeurologicaRDevices

Prescription Use (PER 21 CFR 801.109) Over-The-Counter Use

510(k) Number K012871

(Optional Format 1-2-96)

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510(k) Number (if known):

Synergy Ti Fenestrated Integral Open 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.

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.

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number $\frac{K012871}{(Page 2 of 2)}$

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.