When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients:
a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine
d) who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of 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, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Device Description

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

AI/ML Overview

The provided text is a 510(k) summary for the Silhouette™ Spinal Fixation System, a medical device for spinal fixation. It describes the device, its intended use, and indicates that it has been found substantially equivalent to predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

This type of 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical trial or performance study data with specific acceptance criteria as might be seen for novel devices or those requiring a PMA.

Therefore, I cannot fulfill your request for the tables and information regarding acceptance criteria and performance studies based on the provided text. The document is essentially a regulatory clearance notice, not a detailed technical or clinical study report.

Summary

{0}------------------------------------------------

KO12173

SEP 2 8 2001

510(k) Summary

Submitter:	Sulzer Spine-Tech7375 Bush Lake RoadMinneapolis, Minnesota 55439
Date Prepared:	September 20, 2001
Contact:	Kristyn M. BensonRegulatory Affairs Associate
Proprietary Name:	Silhouette™ Spinal Fixation System
Common Name:	Rod, hook, and screw spinal instrumentation
Device Product Code& Classification:	Class II; MNI, MNH, and KWP
Predicate Device:	Silhouette™ Spinal Fixation System(K980288 & K992276)

Device Description:

Intended Use:

When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and degenerative spondylolisthesis with objective evidence of sacral spine: neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients:

a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
Silhouette™ Spinal Fixation System Special 510(k) Notification

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

b) who are receiving fusions with autogenous graft only
who are having the device fixed or attached to the lumbar or sacral spine c)
o) who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of 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, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and trevious failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Silhouette™ Spinal Fixation System Special 510(k) Notification

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines representing the snake winding around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2001

Ms. Kristyn M. Benson Regulatory Affairs Associate Sulzer Spine-Tech 7375 Bush Lake Rod Minneapolis, Minnesota 55439

Re: K012173

Trade Name: SILHOUETTE™ Spinal Fixation System 4.5mm pedicle screw Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Appliance fixation, Spinal Interlaminal Fixation Orthosis; Orthosis, Spondylolisthesis Spinal Fixation Device System, Orthosis, Spinal Pedicle Screw Fixation Spinal System Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: September 20, 2001 Received: September 21, 2001

Dear Ms. Benson:

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 for abo bated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of prior to rialy 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometer For (110) tax the device, subject to the general controls provisions of the Act. The r ou may , atests 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 may be babyer is basil as also as a legulations, 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 cormply 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.

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

Page 2 - Ms. Kristyn M. Benson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Mark N. Mikkelsen

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

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

K012173 510(k) Number:

Silhouette™ Spinal Fixation System Device Name:

Indications for Use:

When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stahilization of spinal segments 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, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients:

a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine
d) who are having the device removed after the development of a solid fusion mass

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

Mark N Milberson

. Restorative

Kola1

510(k) Number

Image /page/4/Picture/17 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font size. There is a line drawn under the words "Prescription Use" with a symbol that looks like a greater than sign and an X over the line. The text indicates that the product is for prescription use only, according to the Code of Federal Regulations.

Over-the-Counter-Use __

Silhouette™ Spinal Fixation System Special 510(k) Notification

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.