SPIRAL RADIUS RODDING SYSTEM

K000009 · United States Surgical, A Division of Tyco Healthc · KWQ · Mar 10, 2000 · Orthopedic

Device Facts

• Record ID: K000009
• Device Name: SPIRAL RADIUS RODDING SYSTEM
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 10, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The components of the Spiral Radius Rodding System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis). When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis). When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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 (d) who are having the device removed after the development of solid fusion mass. In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding 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 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 (pseudoarthrosis).

Device Story

Spiral Radius Rodding System; spinal fixation implant; consists of rods, screws, hooks, and crosslinks. Used for anterolateral/anterior, nonpedicle posterior, or pedicle screw fixation. Implanted by surgeons in clinical settings to provide immobilization and stabilization of spinal segments; adjunct to fusion. Benefits patients by treating spinal instabilities, deformities, and degenerative conditions. Titanium alloy construction.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Implant grade wrought Titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5835/3. System components include rods, screws, hooks, and crosslinks for spinal fixation.

Indications for Use

Indicated for patients requiring spinal fixation for degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed fusion. Pedicle screw use restricted to skeletally mature patients with severe spondylolisthesis (Grades 3-4) at L5-S1, or acute/chronic instabilities of thoracic, lumbar, and sacral spine requiring immobilization/stabilization as an adjunct to fusion.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• USS’s Spiral Radius Rodding System (K992784)

Submission Summary (Full Text)

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MAR 10 2006
Ko00009
1 of 2
Spiral Radius Rodding System

# IX. Summary of Safety and Effectiveness

**SUBMITTER:** United States Surgical
A division of Tyco Healthcare Group, LP
150 Glover Avenue
Norwalk, CT 06856

**CONTACT PERSON:** Luis Nesprido

**DATE PREPARED:** December 29, 1999

**CLASSIFICATION NAME:** Spinal Intervertebral Body Fixation Orthosis
Spinal Interlaminal Fixation Orthosis
Spondylolisthesis Spinal Fixation Device System

**COMMON NAME:** Titanium Spinal Rod System

**PROPRIETARY NAME:** Spiral Radius Rodding System

**PREDICATE DEVICES:** USS’s Spiral Radius Rodding System – K992784

**INTENDED USE:** The components of the Spiral Radius Rodding System are indicated for spinal fixation.

When used as an *anterolateral/anterior* system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a *nonpedicle posterior* system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a *pedicle screw* system, in the non-cervical spine of skeletally mature patients, The Spiral Radius Rodding System is

United States Surgical
Premarket Notification
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KCCCCC9
Spiral Radius Rodding System
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indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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 (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a *pedicle screw* system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding 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 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 (pseudoarthrosis).

**MATERIALS:**

The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (Ti-6Al-4V).

United States Surgical
Premarket Notification
Page 19

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAR 10 2000

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Luis Nesprido
Regulatory Affairs Associate
United States Surgical Corporation
150 Glover Avenue
Norwalk, Connecticut 06856

Re: K000009
Trade Name: Spiral Rodding System
Regulatory Class: II
Product Code: KWQ, KWP, MNH, and MNI
Dated: December 29, 1999
Received: January 3, 2000

Dear Mr. Nesprido:

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 - Mr. Luis Nesprido

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,


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

Enclosure

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Spiral Radius Rodding System

## IV. Indications for Use

510(k) Number (if known): k000009

Device Name: Spiral Radius Rodding System

Indications For Use:

The components of the Spiral Radius Rodding System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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 (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius Rodding 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 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 (pseudoarthrosis).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ☑ OR Over-The-Counter Use:

(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K000009

United States Surgical
Premarket Notification