S4 SPINAL SYSTEM

K062085 · Aesculap · NKB · Mar 2, 2007 · Orthopedic

Device Facts

• Record ID: K062085
• Device Name: S4 SPINAL SYSTEM
• Applicant: Aesculap
• Product Code: NKB · Orthopedic
• Decision Date: Mar 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 join; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spin; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum. The S4 Spinal 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 spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or iumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Device Story

S4 Spinal System is a posterior spinal fixation construct consisting of polyaxial/monoaxial screws, hooks, rods, and rod-to-rod connectors. Used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Components are top-loading and top-tightening. Device provides mechanical support to the spine to facilitate fusion in patients with acute/chronic instabilities or deformities. Benefits include stabilization of the spinal column, correction of deformities, and support for bone graft healing.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Titanium and Titanium alloy per ISO 5832/3 and ISO 5832/2. Components: Polyaxial/monoaxial screws, hooks, rods, rod-to-rod connectors. Design: Top-loading, top-tightening. Mechanical fixation system.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, degenerative disc disease, spinal stenosis. Levels: T1 to sacrum (hooks/sacral screws); L3 to sacrum (pedicle screws).

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

• S4 Spinal System (K032219)

Submission Summary (Full Text)

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SPECIAL 510(k) Premarket Notification

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S4 Spinal System

| Page 1 of 2 | MAR 02 2007 |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. 510(k) SUMMARY (as required by 21 CFR 807.92) | |
| S4 Spinal System<br>July 20, 2006 | |
| COMPANY: | Aesculap ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
| CONTACT: | Kathy A. Racosky<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | S4 |
| COMMON NAME: | S4 Spinal System |
| DEVICE CLASS: | Class III |
| PRODUCT CODE: | MNI, MNH, KWP, and NKB |
| REGULATION NUMBER: | 888.3070 - Orthosis, Spinal Pedicle Fixation<br>888.3070 - Orthosis, Spondyloisthesis Spinal<br>Fixation<br>888.3050 - Appliance, Fixation, Spinal Fixation<br>888.3070 - Orthosis, Spinal Pedicle Fixation, For<br>Degenerative Disc Disease |
| REVIEW PANEL: | Orthopedics |

# SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the modified S4 Spinal System is substantially equivalent to our S4 Spinal System (K032219).

## DEVICE DESCRIPTION

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, and fixed and adjustable rod to rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

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SPECIAL 510(k) Premarket Notification

K062085

Page 2 of 2

## INDICATIONS FOR USE

The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 join: b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The S4 Spinal 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 spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor,

and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

# TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The modified and new components of the S4 Spinal System are offered in similar shapes and sizes as the predicate devices. All the components are manufactured from Titanium and Titanium Alloy, which is the same material as the predicate devices.

### PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the "Spinal System 510(k)s" was completed where applicable.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of a bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems Inc. % Ms. Kathy A. Racosky Regulatory Affairs Associate 3773 Corporate Parkway Center Valley, Pennsylvania 18034

MAR 0 2 2007

Re: K062085

> Trade/Device Name: S4 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP Dated: January 31, 2007 Received: February 1, 2007

Dear Ms. Racosky:

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, 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 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 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 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 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.

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Page 2 - Ms. Kathy A. Racosky

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 240-276-0120. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ifferently, yours,

Mark A. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SPECIAL 510(k) Premarket Notification

S4 Spinal System

Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

510(k) Number: K062085

Device Name: S4 Spinal System

### Indications for Use:

Mark N. Melkerson

Division of General, Restorative, and Neurological Devices

**510(k) Number** K062085

The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 join; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spin; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The S4 Spinal 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 spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or iumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

| Prescription Use | X | and/or Over-the-Counter Use | |
|-----------------------------|---|-----------------------------|--|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) | |

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