TSRH SPINAL SYSTEM

K021170 · Medtronic Sofamor Danek USA, Inc. · KWP · Jul 9, 2002 · Orthopedic

Device Facts

• Record ID: K021170
• Device Name: TSRH SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is intended for 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: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and (8) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature 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 (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. When used as an anterolateral/anterior system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and into anterior vertebral bodies of the cervical spine.

Device Story

TSRH® Spinal System is a modular orthopedic implant set comprising rods, hooks, screws, and cross-connectors; used for spinal stabilization and fusion. Components are surgically implanted by surgeons in clinical settings to treat spinal deformities or instabilities. System allows for rigid locking of constructs tailored to individual patient anatomy. Components are fabricated from stainless steel or titanium alloy. Device provides mechanical support to spinal segments to facilitate bone fusion; benefits include correction of spinal alignment and stabilization of unstable segments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Components fabricated from stainless steel (ASTM F-138, ISO 5832-1/9) or titanium alloy (ASTM F-136, ISO 5832-3) or medical grade titanium (ASTM F67). Modular system with various rods, hooks, screws, and connectors. Sterile or non-sterile.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats degenerative disc disease, spondylolisthesis, fractures, dislocations, scoliosis, kyphosis, spinal tumors, spinal stenosis, and pseudarthrosis in thoracic, lumbar, and sacral spine. Specific indications for severe L5-S1 spondylolisthesis (Grades 3-4) using autogenous bone graft.

Regulatory Classification

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.

Predicate Devices

• CD® Spinal System
• TSRH® Spinal System (Medtronic Sofamor Danek)

Submission Summary (Full Text)

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K021170

# TSRH® Spinal System 510(k) Summary June 2002

## JUL 9 2002

Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 [phone]

Proposed Proprietary Trade Name: TSRH® Spinal System II.

### III. Description

The purpose of this 510(k) submission is to incorporate additional TSRH®-3D screw sizes into the system.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. In addition, GDLH® rods, DYNALOK PLUSTM bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON® set screws and locking screws may be used with the TSRH® Spinal System.

The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® connectors and TSRH-3D® screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

The TSRH® Spinal System components are fabricated from stainless steel conforming to ASTM F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, they may be fabricated from medical grade titanium alloy conforming to ASTM F-136 or ISO 5832-3 or medical grade titanium conforming to ASTM F67. The TSRH® Spinal System may be sold sterile or non-sterile.

#### IV. Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is intended for immobilization and

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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: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature 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 (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral/anterior system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and into anterior vertebral bodies of the cervical spine.

- The TSRH®-3D screws were declared substantially equivalent to the CD® Spinal V. System 4.0mm screws and to the TSRH® Spinal System manufactured by Medtronic Sofamor Danek. Mechanical test data was provided in this application.
© 2002 Medtronic Sofamor Danek

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered in the image. The words are stacked on one line.

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## ப்பட 9 2002

Richard W. Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek 1800 Pvramid Place Memphis, Tennessee 38132

Re: K021170

> TSRH® Spinal System - 3D Screws Regulation Numbers: 888.3050, 888.3060, and 888.3070 Regulation Names: Spinal Interlaminal Fixation Orthosis; Spinal Intervertebral Body Fixation Orthosis; Spondylolisthesis Spinal Fixation Device System; and Pedicle Screw Spinal System Regulatory Class: II Product Codes: KWP; KWQ; MNI; and MNH Dated: April 10, 2002 Received: April 12, 2002

Dear Dr. Treharne:

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

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# Page 2 - Richard W. Treharne, Ph.D.

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.

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

Sincerely yours,

Neil R P Ogden

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

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# 510(k) Number (if known): KO21170

TSRH® Spinal System Device Name:

## Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® System is intended for 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: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment. (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst 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 (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral/anterior system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis. (7) tumor resection, and/or (8) failed previous fusion. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and into anterior vertebral bodies of the cervical spine.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Evaluation (ODE)

NKo for cmw

Jivision Sign=C vision of General, Restorative and Neurological Devices

510(k) Number K021170
OR Over-the-counter Use

Prescription Use X (Per 21 CFR 801.109) (Optional 1-2-96)

Over-the-counter Use