UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063

K091190 · Zimmer Spine, Inc. · JDQ · Jul 30, 2009 · Orthopedic

Device Facts

• Record ID: K091190
• Device Name: UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
• Applicant: Zimmer Spine, Inc.
• Product Code: JDQ · Orthopedic
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Universal Clamp Stainless Steel 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 Stainless Steel System is a temporary orthopedic 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 fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar. interspinous, or facet wiring techniques. - Spinal reconstructive surgery, incorporated into 2. constructs for the purpose of correction of spinal deformities such કર scoliosis, kvohosis. spondylolisthesis. - 3. Spinal degenerative surgery, as an adjunct to spinal fusions; The Universal Clamp Stainless Steel 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.

Device Story

Temporary orthopedic implant system; provides stabilization as bone anchor during bony fusion or fracture repair. Used in spinal trauma, reconstructive, and degenerative surgeries. Operates as mechanical fixation device; used in conjunction with other stainless steel implants to secure attachments. Surgeon-operated in clinical/OR setting. Provides mechanical stability to bone constructs; facilitates fusion and fracture healing. Benefits patient by maintaining alignment and structural integrity during recovery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel orthopedic implant system. Functions as bone fixation cerclage. Mechanical stabilization device. No software or energy source.

Indications for Use

Indicated for orthopedic surgery patients requiring temporary stabilization as a bone anchor during bony fusion or fracture repair. Applications include spinal trauma (sublaminar, interspinous, or facet wiring), spinal reconstruction (scoliosis, kyphosis, spondylolisthesis), and spinal degenerative surgery as an adjunct to fusion. May be used with other stainless steel implants.

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

• Abbott Spine Universal Clamp Stainless Steel System (K081622)

Submission Summary (Full Text)

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## Zimmer Spine SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER:

Zimmer Spine

JUL 30 2009

3003853072

David Padgett, RAC (US) Senior Specialist, Regulatory Affairs Telephone: [phone] Fax: [phone]

June 30, 2009

Universal Clamp® Stainless Steel System

JDQ

Bone Fixation Cerclage

21 CFR § 888.3010

Abbott Spine Universal Clamp Stainless Steel System

The Universal Clamp Stainless Steel 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 Stainless Steel System is a temporary orthopedic 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 fractures. The indications for use include the following applications:

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

The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made

CONTACT PERSON:

TRADE NAME:

Date:

Product Code:

CLASSIFICATION NAME:

Classification Reference:

MANUFACTURER ESTABLISHMENT

REGISTRATION NUMBER:

PREDICATE DEVICE:

DEVICE DESCRIPTION:

INDICATIONS:

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of stainless steel whenever "wiring" may help secure the attachment of other implants.

## COMPARISON TO PREDICATE DEVICE:

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® Stainless Steel System is substantially equivalent to the predicate stainless steel version cleared under premarket notification K081622.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a seal or emblem.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 30 2009

Zimmer Spine % Mr. David Padgett, RAC Senior Specialist, Regulatory Affairs 5301 Riata Park Court, Building F Austin, TX, 78727

Re: K091190

Trade/Device Name: Clamp® Stainless Steel System Regulation Number: 21 CFR 888.3010 · Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: June 30, 2009 Received: July 2, 2009

Dear Mr. Padgett:

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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. David Padgett, RAC

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Harbara Buchus

fris

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K091190

## Device Name:

Universal Clamp® Stainless Steel System

### Indications for Use:

The Universal Clamp Stainless Steel 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 the following applications:

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

The Universal Clamp Stainless Steel 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.

Prescription Use X (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 CDBH. Office of Device Evaluation (ODE) (ExT forma) (Division Sign-Off) Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number K091190