ABBOTT SPINE UNIVERSAL CLAMP SYSTEM

K060009 · Abbott Spine, Inc. · JDQ · Mar 6, 2006 · Orthopedic

Device Facts

• Record ID: K060009
• Device Name: ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
• Applicant: Abbott Spine, Inc.
• Product Code: JDQ · Orthopedic
• Decision Date: Mar 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Universal Clamp System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques: 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis: 3. Spinal degenerative surgery, as an adjunct to spinal fusions; The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

Device Story

Universal Clamp System is a temporary orthopedic implant; functions as a bone anchor to provide stabilization during bony fusion or fracture repair. Used in spinal trauma, reconstructive, and degenerative surgeries; facilitates sublaminar, interspinous, or facet wiring. Designed for use in conjunction with other medical implants (titanium alloy or stainless steel) to secure attachments. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization to assist bone healing; benefits patient by maintaining construct integrity during fusion process.

Clinical Evidence

Bench testing only. Engineering evaluations and mechanical testing were conducted to assess physical and mechanical properties; results demonstrate performance equivalent to the predicate device.

Technological Characteristics

Temporary orthopedic bone fixation cerclage system. Materials include titanium alloy and stainless steel. Mechanical stabilization principle via wiring/clamping. Designed for integration with other spinal constructs.

Indications for Use

Indicated for patients undergoing orthopedic surgery requiring temporary bone stabilization or fracture repair, including spinal trauma, spinal reconstruction (scoliosis, spondylolisthesis), and spinal degenerative surgery as an adjunct to fusion.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• CFix Cable System (K974020)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings outstretched. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abbott Spine, Inc % Ms. Maritza Elias Senior Regulatory Affairs Specialist 5301 Riata Park Court, Building F Austin, Texas 78727

Re: K060009

Trade/Device Name: Abbott Spine Universal Clamp System Regulation Number: 21 CFR 888.3010 Regulation Names: Bone fixation cerclage. Regulatory Class: II Product Code: JDQ Dated: February 17, 2006 Received: February 18, 2006

Dear Ms. Elias:

This letter corrects our substantially equivalent letter of March 06, 2006.

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. Drue. 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 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.

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Page 2 - Ms. Maritza Elias

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

Mark N. Melkerson 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

510(k) Number (if known): K060009

Device Name:

Abbott Spine Universal Clamp System

## Indications for Use:

The Universal Clamp System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications:

- 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques:
- 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis:
- 3. Spinal degenerative surgery, as an adjunct to spinal fusions;

The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

Mark M. Milless

abuir aurologic

510(k) Number

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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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## ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:

Abbott Spine Inc.

October 03, 2008

JDQ

Universal Clamp® System

Bone Fixation Cerclage

21 CFR § 888.3010

Establishment Registration Number:

Contact Person:

1649384

Maritza Elias Senior Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]

Trade Name:

Date:

Product Code:

CLASSIFICATION NAME:

CLASSIFICATION REFERENCE:

Predicate Device:

Device Description:

INDICATIONS:

CFix Cable System (K974020)

The Universal Clamp System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

The Universal Clamp System is a temporary implant for use in orthopedic surgerv. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications:

- 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction

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of spinal deformities such as scoliosis, kyphosis, spondylolisthesis;

3. Spinal degenerative surgery, as an adjunct to spinal fusions;

The Universal Clamp System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Universal Clamp System is substantially equivalent to the CFix Cable system.

## SUBSTANTIAL EQUIVALENCE: