SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM

K973836 · Cross Medical Products, Inc. · MNH · Mar 5, 1998 · Orthopedic

Device Facts

• Record ID: K973836
• Device Name: SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
• Applicant: Cross Medical Products, Inc.
• Product Code: MNH · Orthopedic
• Decision Date: Mar 5, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As a pedicle screw system, it 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 receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; 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. As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications 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). 2. Idiopathic scoliosis. 3. Kyphotic deformities of the spine. 4. Paralytic scoliosis and/or pelvic obliquity. 5. Lordotic deformities of the spine. 6. Neuromuscular scoliosis associated with pelvic obliquity. 7. Vertebral fracture or dislocation. 8. Tumors. 9. Spondylolisthesis. 10. Stenosis. 11. Pseudarthrosis. 12. Unsuccessful previous attempts at spinal fusion. For posterior, non-pedicle screw use, the levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.

Device Story

SYNERGY™ Spinal System-Additional Components; temporary spinal construct for stabilization during fusion procedures. Posterior application via hooks/screws joined with rods; anterior application via vertebral screws joined with rods. Used in OR by surgeons; assists normal healing; not intended to replace body structures. Components include various screws (open, closed, reduction, variable locking, iliac), hooks, transverse/rod/lateral connectors, rods, and instruments. Implanted via specialized spinal surgery techniques; requires removal after solid fusion mass development. Benefits include spinal stabilization; potential risks include component fracture, loss of fixation, non-union, vertebral fracture, neurological/vascular/visceral injury.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by mechanical testing, engineering analysis, and established design/material history.

Technological Characteristics

Implantable components: Titanium alloy (ASTM F136), CP Titanium (ASTM F67), 22-13-5 Stainless Steel (ASTM F1314), 316L Stainless Steel (ASTM F138). Instruments: Stainless steel (ASTM A276, A564/A564M, F899), medical-grade plastics (Ultem, Radel), silicone rubber. Non-sterile; requires steam sterilization (gravity cycle, 250°F/121°C, 60 mins).

Indications for Use

Indicated for patients with severe spondylolisthesis (Grades 3-4, L5-S1) requiring fusion with autogenous bone graft; also indicated for degenerative disc disease, scoliosis (idiopathic, paralytic, neuromuscular), kyphotic/lordotic deformities, vertebral fracture/dislocation, tumors, stenosis, pseudarthrosis, and failed prior fusion. Contraindicated in patients with rigid scoliotic curves, vague spinal anatomy, bony abnormalities preventing safe fixation, metal sensitivities, morbid obesity, severe osteopenia, or active infections.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SYNERGY™ Anterior Spinal System (K934429, K950709)
• SYNERGY™ Posterior Spinal System (K940631, K950099)

Submission Summary (Full Text)

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K973836 (p1 of 5)

# 510(k) Summary of Safety and Effectiveness

MAR - 5 1998

# Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

# Company Name/Contact:

Regulatory Affairs Department Cross Medical Products, Inc. 5160-A Blazer Memorial Parkway Dublin, OH 43017-1339 614-718-0530, Fax [phone]

### Device Name:

Trade Name: SYNERGY™ Spinal System-Additional Components

Common Name(s): Anterior Spine Implants, Posterior Spine Implants, Universal Spine System

### Classification Name(s):

Spinal Intervertebral Body Fixation Orthosis Appliance, Fixation, Spinal Interlaminal Spondylolisthesis Spinal Fixation Device System

### Establishment Registration: 1526354

# Classification:

The Orthopaedic and Rehabilitation Devices Panel assigned the unique device classification codes KWP and KWQ to this device system. The published physical description of these devices is in 21 CFR, 888.3050 and 888.3060. In addition, they are presently Class II medical devices. Class II medical devices are subject to Performance Standards. This device is also categorized under MNH (Spondylolisthesis Spinal Fixation), which is unclassified.

#### Performance Standards:

Performance Standards applicable to the Cross® Medical- SYNERGY™ Spinal System have not been published by FDA. Cross® Medical Products, Inc. produces this device according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present. Voluntary performance standards, such as materials certifications, in-house SOP's and/or ASTM Standards are utilized as appropriate.

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K973836 (p. 2 of 5)

### Substantially Equivalent Device(s):

1. SYNERGY™ Anterior Spinal System: K934429, K950709

2. SYNERGY™ Posterior Spinal System: K940631, K950099

### Device Description:

Background: This document summarizes safety and effectiveness information for the SYNERGY™ Spinal System-Additional Components contained in the 510(k) Premarket Notification submitted to FDA in support of its substantial equivalence.

Purpose: The SYNERGY™ Spinal System is intended to be used a part of a temporary construct that assists normal healing and is not intended to replace normal body structures. It is intended to help stabilize the spinal operative site during fusion procedures. It attaches to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.

The posterior application components are grouped as follows:

- 1. INTEGRALTM 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 INTEGRALTM Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation (see INDICATIONS).
- 2. Open and Closed Spinal Hooks with Sliders, C-Rings and Set Screws.
- 3. Adjustable and Fixed Transverse connectors with Set Screws.
- 4. Closed and Axial Rod Connectors with Set Screws.
- 5. Lateral Connectors with Set Screws.
- 6. Rods.
- 7. Instruments.
- 8. Sterilizer case(s).

The anterior application components are grouped as follows:

- 1. INTEGRAL™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.

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K973836 (p. 3 of 5)

2. Vertebral Washers.

3. Fixed Transverse Connectors with Set Screws.

4. Rods.

5. Instruments.

6. Sterilizer case(s).

Material: The implantable components may be made from either titanium or stainless steel. The titanium version consists of surgical implant grade titanium alloy as described by ASTM Standard F136 (Ti 6A1-4V ELI), and commercially pure titanium, grade 2 as described by ASTM Standard F67 (CP Ti, Gr. 2). The stainless steel version consists of surgical implant grade stainless steel as described by ASTM standard F1314 (22-13-5 Stainless Steel), and surgical implant grade stainless steel as described by ASTM standard F138, Grade 2 (316L Stainless Steel).

### Indications for Use:

As a pedicle screw system, it 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 receiving fusions using autogenous bone graft only; © who are having the screws fixed or attached to the lumbar and sacral spine; 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.

As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications 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).
- 2. Idiopathic scoliosis.
- 3. Kyphotic deformities of the spine.
- Paralytic scoliosis and/or pelvic obliquity. বা
- 5. Lordotic deformities of the spine.
- Neuromuscular scoliosis associated with pelvic obliquity. 6.
- 7. Vertebral fracture or dislocation.
- 8. Tumors.
- 9. Spondylolisthesis.

10. Stenosis.

- 11. Pseudarthrosis.
- 12. Unsuccessful previous attempts at spinal fusion.

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K973836(P. 4 of 5)

For posterior, non-pedicle screw use, the levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.

# Contraindications and Cautions:

The existence of the following conditions generally excludes candidates from treatment with spinal implants. Patients with rigid scoliotic curves vague spinal anatomy, bony abnormalities preventing safe screw fixation, metal sensitivities, morbid obesity, severe osteopenia, active localized infections or other disseminated infections (septicemia). In general, the SYNERGY™ Spinal System should only be implanted by surgeons fully experienced in the use of such implants and the required specialized spinal surgery techniques.

Note: The Cross® Medical- SYNERGY™ Spinal System Instrumentation Technique Manual should be carefully followed. It supplies important information on proper usage of the implants and instruments.

Packaging: All packages containing implants or instruments should be sealed and intact upon receipt. The product should not be used and should be immediately returned to Cross® Medical Products, Inc. if the package or product is damaged.

#### Sterilization:

The SYNERGY™ Spinal System is shipped non-sterile. All packaging materials must be removed prior to sterilization.

High temperature steam sterilization should be used, with the following cycle having been laboratory validated:

| Method: | Steam |
|----------------|-------------------------------|
| Cycle: | Gravity |
| Temperature: | 250 degrees F (121 degrees C) |
| Exposure Time: | 60 minutes |

Note: It is recommended to dry and/or cool the parts to prevent condensation after the steam cycle .. Only sterile products should be used in the operative field.

The recommended sterilization cycle is based on HIMA/AORN protocols. Other sterilization methods and cycles may also be suitable. However, individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques.

#### Product Complaints:

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K973836(P.5 of 5)

Any dissatisfaction with the product quality, labeling or performance should be reported to Cross® Medical Products, Inc. immediately by the customer or user. Furthermore, if any of the implants "malfunction." (i.e. do not meet any of their performance specifications or otherwise do not perform as intended) and may have caused or contributed to the death or serious injury of the patient, Cross® Medical Products, Inc. should be notified immediately by telephone, fax, or written correspondence.

When filing a complaint, the name, part number and lot number of the part should be provided along with the name and address of the person filing the complaint. In addition, the nature of the complaint should be clearly communicated along with a notification of whether a written report from Cross® Medical Products, Inc. is requested.

### Instrumentation:

No additional device specific instrumentation is necessary for insertion and anchoring of the SYNERGY™ Spinal System-Additional Components that are not already part of the commercially available SYNERGYTM Spinal System. The instruments are made from stainless steel meeting ASTM A276, ASTM A564/A564M, and ASTM F899 standards. Established medical grade plastics (Ultem and Radel) and Silicone Rubber are used to construct the handles, cases, etc.

# Substantial Equivalence:

The SYNERGY™ Spinal System-Additional Components are substantially equivalent to the SYNERGY™ Anterior and Posterior, Stainless Steel and Titanium Spinal System as cleared under K934429, K940631, K950099, and K950709.

All of these devices are used to treat similar or the same conditions, have essentially the same cautions and contraindications for use, and have equivalent potential for complications for risk of use. All represent a long standing, basic design concept and in terms of safety and effectiveness, differ only in minor details.

#### Conclusion:

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, Cross® Medical Products, Inc. believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to existing legally marketed screws as components of universal spine systems.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Phil Mellinger CROSS® Medical Products, Inc. 5160-A Blazer Memorial Parkway Dublin, Ohio 43017-1339

Re : K973836 SYNERGY™ Spinal System - additional components Requlatory Class: II Product Codes: MNH, KWP, and KWQ Dated: January 29, 1998 Received: January 30, 1998

Dear Mr. Mellinger:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act) . . found equivalent only to similar device systems labeled and 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; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f)(1) of the Act.

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III

MAR - 5 1998

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### Page 2 - Mr. Phil Mellinger

device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

- All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws 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 receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- 2. You may not label or in anyway promote this device system for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

#### WARNINGS :

- . When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- The screws of this device system are not intended � for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- . Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
- Potential risks identified with the use of this . device system, which may require additional surgery, include :

device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

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Page 3 - Mr. Phil Mellinger

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

- Any pedicular screw fixation/attachment for intended uses 3 . other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) requlations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- Any previous warning statements identified as part of 4 . previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.

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 Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 Reqister. 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.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.

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# Page 4 - Mr. Phil Mellinger

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] 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

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#### 510(k) Number (if known): K973836

# Device Name: SYNERGY™ Spinal System- additional components

### Indications For Use:

As a pedicle screw system, it is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacrai (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; © who are having the screws fixed or attached to the lumbar and sacral spine; 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.

As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications 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).
- 2. Idiopathic scoliosis.
- 3. Kyphotic deformities of the spine.
- 4. Paralytic scoliosis and/or pelvic obliquity.
- న్. Lordotic deformities of the spine.
- 6. Neuromuscular scoliosis associated with pelvic obliquity.
- 7. Vertebral fracture or dislocation.
- 8. Tumors.
- ರ. Spondylolisthesis.
- 10. Stenosis.
- 11. Pseudarthrosis.
- 12. Unsuccessful previous attempts at spinal fusion.

For posterior, non-pedicle screw use, the levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Restorative De 510(k) Numb

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use