S4 SPINAL SYSTEM

K050979 · Aesculap, Inc. · MNI · Jul 27, 2005 · Orthopedic

Device Facts

• Record ID: K050979
• Device Name: S4 SPINAL SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Jul 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and the thoracic spine (C1 -T3), the S4 Spinal System is intended for the following; - DDD (Neck pain pf discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies) - Spondvlolisthesis . - Spinal stenosis . - Fracture/dislocation . - Failed previous fusion . - Tumors . The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -- T3) spine. The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Device Story

S4 Spinal System is a posterior spinal fixation system used by surgeons to stabilize the cervical and upper thoracic spine (C1-T3) to promote fusion. Components include 3.5mm rods, lamina hooks, and a cross connector. Polyaxial screws are utilized specifically for thoracic (T1-T3) stabilization. The system is implanted during surgical procedures to address degenerative disc disease, fractures, dislocations, tumors, or failed prior fusions. By providing rigid fixation, the device maintains spinal alignment, facilitating bone fusion and patient recovery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Constructed from Titanium forged alloy (Ti6Al4V). System includes 3.5mm diameter rods, lamina hooks, polyaxial screws, and cross connectors. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for patients requiring spinal fusion or stabilization in the cervical and upper thoracic spine (C1-T3) due to DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, failed previous fusion, or tumors. Polyaxial screws restricted to T1-T3 thoracic use only; contraindicated for cervical spine placement.

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

• Nex-Link Spinal System (K031985)
• Vertex Spinal System (K042789, 042524)
• Summit Spinal System (K013222, K030103, K041203)

Submission Summary (Full Text)

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Koso979
S4 Spinal System

## JUL 27 2005

Page 1 of 2

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS C.

[in Accordance with SMDA of 1990]

### S4 Spinal System

April 18, 2005

Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034

Establishment Registration Number: 2916714

Joyce Kilroy CONTACT: 800/258-1946 x 5074 (phone) 610/791-6882 (fax)

SA TRADE NAME:

COMMON NAME: S4 Spinal System

DEVICE CLASS: Class II

PRODUCT CODE: MNI, KWP

CLASSIFICATION: 888.3070 - Pedicle screw spinal system

888.3050 - Spinal interlaminal fixation orthosis

REVIEW PANEL: Orthopedics

## INDICATIONS FOR USE

When intended to promote fusion of the cervical spine and the thoracic spine (C1 -T3), the S4 Spinal System is intended for the following;

- DDD (Neck pain pf discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies)
- Spondvlolisthesis .
- Spinal stenosis .
- Fracture/dislocation .
- Failed previous fusion .
- Tumors .

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -- T3) spine.

The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

## DEVICE DESCRIPTION

The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 The 64 Opinal System of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

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# PERFORMANCE DATA

PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications where All required testing per Drait Ouldance Tor Roll Clements" were done where
(510(k)s) Applications for Orthopedic Devices-The Basic Elements "who (310(K)S) Applications for Orthopodio Dotholo Riosem 510(K)s" was completed where applicable.

# SUBSTANTIAL EQUIVALENCE

Aesculap believes that the new S4 Spinal System is substantially equivalent in design to:

- Nex- Link Spinal System (K031985) .
- Vertex Spinal System (K042789, 042524) .
- Summit Spinal System (K013222, K030103, K041203) .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The caduceus is surrounded by a circle of text that reads "U.S. Department of Health and Human Services, USA."

JUL & 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Joyce Kilroy Director of Regulatory Affairs/Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K050979

Trade/Device Name: S4 Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: 21 CF CF 866558888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Regulatory Class: II Product Code: KWP, MNI Dated: July 20, 2005 Received: July 21, 2005

Dear Ms. Kilroy:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becaren of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to togensy to tegains.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the ridge 2011-12-11 in accordance with the provisions of the Federal Food, Drug, de nees mat have been that do not require approval of a premarket approval application (PMA). and Cosmotic Ace (110) that the device, subject to the general controls provisions of the Act. The I ou may, mercrore, mains of the Act include requirements for annual registration, listing of general controll pro resering 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 rryour device is elassified (600 a00 rols. Existing major regulations affecting your device can thay or subject to observed 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 docs not mean r rouse of acrease a determination that your device complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any I vith 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 Of to rate 077) accesses (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. Joyce Kilroy

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to oghi maxing of substantial equivalence of your device to a legally premarket notheation: "The PDF Intains of cour 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 If you desire specific advice for your acon) 276-0120. Also, please note the regulation entitled, Connact the Office of Compraiset notification" (21CFR Part 807.97). You may obtain Misoranding of reference to premail.org/w/index.php?title=Ret from the Division of Small other general information on your response at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millman

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

Enclosure

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#### INDICATIONS FOR USE STATEMENT B.

Page 1 of 1

510(k) Number: K050979

S4 Spinal System Device Name:

### Indication for Use:

When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;

- DDD (Neck pain pf discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- Spinal stenosis ●
- Fracture/dislocation .
- Failed previous fusion .
- Tumors .

The hooks and rods are also intended to provide stabilization to provide fusion The Trooks 'and Tous-The 'are 'interest - trauma in the cervical/upper thoracic (C1 -T3) spine.

The use of the polyaxial screws is limited to placement in T1 – T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Mark W. Millenn

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

510(k) Number_

Prescription Use X or Over-the-Counter Use __

(per 21 CFR 801.109)

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

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