SOCON SPINAL SYSTEM

K993551 · Aesculap, Inc. · MNH · Jan 13, 2000 · Orthopedic

Device Facts

• Record ID: K993551
• Device Name: SOCON SPINAL SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: MNH · Orthopedic
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SOCON® Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the SOCON® Spinal System is 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 neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Story

SOCON Spinal System is a multi-component, single-use spinal fixation system; includes pedicle bone screws, rods, cross bars, and self-locking clamps. Used by surgeons in clinical settings to stabilize spinal segments and promote fusion. Implants attached to thoracic, lumbar, and sacral spine; removed after solid fusion achieved. System provides immobilization as an adjunct to autogenous bone graft fusion. No software or automated processing involved.

Clinical Evidence

No clinical data provided; substantial equivalence based on design identity to predicate and alignment with FDA regulatory requirements for pedicle screw systems.

Technological Characteristics

System components manufactured from titanium alloy (Ti6Al4V) per ISO 5832/3. Instrumentation manufactured from surgical grade stainless steel per ISO 7153/1. Non-sterile, single-use implants. Mechanical fixation system; no energy source, software, or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe spondylolisthesis (Grades 3-4, L5-S1) or acute/chronic instabilities/deformities (thoracic, lumbar, sacral) including degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and pseudarthrosis.

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

• SOCON® Spinal System (K970285)
• VSP System (K984350)

Submission Summary (Full Text)

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# JAN 1 3 2000

K443551
Page 1 of 2

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

## SOCON® SPINAL SYSTEM EXPANDED PEDICLE SCREW INDICATIONS

#### October 19, 1999

- Aesculap®, Inc. COMPANY: 1000 Gateway Blvd. So. San Francisco, CA 94080
- Lia S. Jones, Requlatory Associate CONTACT: 650-624-5073 (phone) 650-589-3007 (fax) [e-mail] (email)
- SOCON® Spinal System TRADE NAME:
- COMMON NAME: Pedicle Screw Spinal Fixation System
- DEVICE CLASS: Class II

PRODUCT CODE: MNH, MNI

- CLASSIFICATION: 888.3070 Spondylolisthesis Spinal Fixation Device System 888.3070 - Pedicle Screw Spinal System
- Orthopedic Devices Branch REVIEW PANEL: Division of General and Restorative Devices

#### DEVICE DESCRIPTION

The SOCON® Spinal System is a multiple component system comprised of a variety of single-use, non-sterile devices that allow the surgeon to build a spinal implant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium alloy, Ti6A14V, in accordance to ISO 5832/3 and include pedicle bone screws, straight and pre-bent rods, cross bars and self-locking clamps. Specialized instrumentation made from surgical grade stainless steel in accordance to ISO 7153/1 is available for the application and removal of the SOCON implants.

#### PURPOSE FOR PREMARKET NOTIFICATION

The sole purpose of this 510(k) is to expand the Indications for Use for Aesculap's current SOCON® Spinal System (#K970285) based on the FDA's publication of the final rule for pedicle screw systems (Federal Register, Vol. 63, No. 143) which became effective on August 26, 1998.

)

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K493551
Page 2 of 2

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

### SOCON® SPINAL SYSTEM EXPANDED PEDICLE SCREW INDICATIONS

October 19, 1999

#### INTENDED USE

The SOCON® Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the SOCON® Spinal System is 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 neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

#### SUBSTANTIAL EQUIVALENCE

There have been no design modifications or technological changes to the current SOCON® Spinal System since receiving FDA clearance under #K970285, and therefore it is substantially equivalent to itself.

For the purpose of this 510(k), however, the expanded Indications for Use are based on the FDA's publication of the final rule for pedicle screw systems (Federal Register. Vol. 63, No. 143) and is substantially equivalent to the recently cleared VSP System (Pedicle Screw Indications) by DePuy AcroMed, Inc. under #K984350.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## GAN 1 3 2000

Ms. Lia S. Jones Regulatory Associate Aesculap . Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7028

Re: K993551

Trade Name: SOCON® Spinal System Regulatory Class: II Product Code: MNH and MNI Dated: October 19, 1999 Received: October 20, 1999

Dear Ms. Jones:

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 control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A 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 action. In addition, FDA may publish further announcements 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.

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.

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Page 2 - Ms. Lia S. Jones

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 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Arnell J. Ayer

James E. Dillard III So Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K493-551

Device Name:

SOCON® Spinal System Expanded Pedicle Screw Indications

Indication for Use:

. "

The SOCON® Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the SOCON® Spinal System is 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 neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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

Thunell Taylor 8-720

Division Sign-Off) . vision of General Restorative Devices 1593551 510(k) Number.

| Prescription Use | X |
|-------------------------|---|
| or Over-the-Counter Use | |
| (per 21 CFR 801.109) | |

(Optional Format 3-10-98)