TETHER ACFS

K010466 · Theken Surgical,Llc · KWQ · May 16, 2001 · Orthopedic

Device Facts

• Record ID: K010466
• Device Name: TETHER ACFS
• Applicant: Theken Surgical,Llc
• Product Code: KWQ · Orthopedic
• Decision Date: May 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tether™ ACFS is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, and spinal stenosis. The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

Device Story

Tether™ ACFS is a titanium alloy anterior cervical plate fixation system; used for temporary spinal stabilization (C2-C7) during arthrodesis. System comprises pre-contoured plates and screws; fixed and variable angle screws allow for rigid or non-rigid constructs; hybrid constructs possible. Locking mechanism engages plate hole upon entry to prevent screw back-out. Device intended for use by surgeons in clinical settings to stabilize spine; provides mechanical support to facilitate fusion; benefits patient by maintaining alignment during healing process.

Clinical Evidence

No clinical data. Bench testing only; static and fatigue testing performed to characterize stiffness, strength, and fatigue life.

Technological Characteristics

Titanium alloy anterior cervical plate fixation system. Components include pre-contoured plates and fixed/variable angle screws. Features mechanical locking mechanism to prevent screw back-out. Non-sterile; intended for surgical implantation.

Indications for Use

Indicated for patients requiring temporary spinal stabilization from C2 to C7 for conditions including trauma, deformity (lordosis, kyphosis, scoliosis), pseudoarthrosis, failed cervical fusion, tumor, discogenic back pain with confirmed degeneration, spondylolisthesis, and spinal stenosis.

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

• Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)

Submission Summary (Full Text)

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510(k) Summary

# MAY 1 6 2001

510 (k) Summary

Tether™ ACFS

Theken Surgical Company: 1100 Nola Avenue Barberton, Ohio 44203

Tether™ ACFS Trade Name:

Classification: KWG 888.3060. Spinal Intervertebral Body Fixation Orthosis. Class II.

The Tether ACFS is a titanium alloy anterior cervical plate fixation system. Description: The Tether AOTO 13 a titaniam anoy and come in a variety of lengths. Screws Prates are pre-contoured in two planos, and two different styles; fixed and variable in two diametors, cororal rengine are used to build a rigid fixation angle and variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws. A locking constructs are possible by comemages the plate hole upon entry into the plate and provides a mechanical lock against screw back-out.

#### Performance Data:

#### Non-clinical:

Static and fatigue testing was performed. Properties of stiffness, strength, and fatique life were characterized.

### Intended Use:

The Tether™ ACFS is indicated for:

The Tether™ ACFS is indicated for trauma, deformity (fordosis, kyphosis and the rether - AGT o lo misus reviously failed cervical spine fusion, turnor, Scollosis), "pscudounthrools," providely as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.

The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

#### Substantial Equivalence:

Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)

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MAY 1 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Randy Theken President Theken Surgical, LLC 1100 Nola Avenue Barberton. Ohio 44203

Re: K010466

Trade Name: TetherTM ACFS Regulation Number: 888.3060 Regulatory Class: Class II Product Code: KWQ Dated: February 15, 2001 Received: February 16, 2001

Dear Mr. Theken:

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 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 (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. Randy Theken

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,

Rmuklellmpr

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): KOLO466

## Device Name: Tether™ ACFS

- 1. Indications for Use:
The Tether™ ACFS is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, scollosis); pocudour.hrools; provised as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), spondylolisthesis, and spinal stenosis.

The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1/2/96)

Muckheeeesa

(Division Sign-Off) (Division Sign of General, Restorative Division of Neurological Devices

510(k) Number 016446