SYNTHES RAPID RESORBABLE TACK SYSTEM

K050204 · Synthes (Usa) · JEY · Mar 4, 2005 · Dental

Device Facts

• Record ID: K050204
• Device Name: SYNTHES RAPID RESORBABLE TACK SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Rapid Resorbable Tack System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Rapid Resorbable Tacks may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Device Story

Synthes Rapid Resorbable Tack System comprises resorbable tacks (1.5 mm and 1.7 mm emergency) and accessory instruments; used for fixation of bone fragments or grafts in craniofacial/mandibular reconstruction. Tacks are non-load bearing; intended for use by surgeons in clinical settings. Device maintains relative position of bone fragments or grafts during healing. Benefits include resorbable material eliminating need for secondary removal surgery. System functions as an extension of the Synthes Rapid Resorbable Fixation System.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resorbable tacks available in 4-6 mm lengths. Composed of resorbable material (Poly (L-Lactide-co-Glycolide)). System includes accessory instruments for placement. Non-load bearing design. Mechanical fixation principle.

Indications for Use

Indicated for fracture repair and reconstructive procedures of the craniofacial skeleton and non-load bearing applications for maintaining position of bony fragments, bone grafts, or bone graft substitutes in craniofacial or mandibular areas. Contraindicated for load-bearing applications (e.g., mandible) unless used with rigid fixation, areas with active/latent infection, patients with limited blood supply or insufficient bone quality/quantity, and spinal use.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Synthes Resorbable Tack System
• Synthes Rapid Resorbable Fixation System (aka Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System)

Submission Summary (Full Text)

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510(k) Summary 3.0

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| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Rapid Resorbable Tack System |
| Classification: | Class II, 21 CFR §882.5360<br>Cranioplasty plate fastener |
| Predicate Device: | Synthes Resorbable Tack System<br>Synthes Rapid Resorbable Fixation System (aka Synthes Poly (L-<br>Lactide-co-Glycolide) Resorbable Fixation System |
| Device Description: | The Synthes Rapid Resorbable Tack System consists of resorbable<br>tacks and accessory instruments, which are additional components<br>of the Synthes Rapid Resorbable Fixation System. The Rapid<br>Resorbable Tack System consists of 1.5 mm tacks and 1.7 mm<br>emergency tacks and are available in lengths ranging from 4 - 6<br>mm. |
| Intended Use: | Synthes Rapid Resorbable Tack System is intended for use in<br>fracture repair and reconstructive procedures of the craniofacial<br>skeleton. In addition, Rapid Resorbable Tacks may be used in non-<br>load bearing applications for maintaining the relative position of<br>and/or containing bony fragments, bone grafts (autograft or allograft)<br>or bone graft substitutes in reconstruction of the craniofacial or<br>mandibular areas. |
| Contraindications: | These devices are not intended for use in load bearing applications,<br>such as the mandible, unless used in conjunction with traditional<br>rigid fixation. Synthes Rapid Resorbable Tacks are not intended for<br>areas with active or latent infection or for patient conditions<br>including limited blood supply or insufficient quantity or quality of<br>bone. These devices are not intended for use in the spine. |
| Substantial<br>Equivalence: | Documentation is provided which demonstrates that Synthes Rapid<br>Resorbable Tack System is substantially equivalent to other legally<br>marketed Synthes devices. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 - 2005

Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K050204

Trade/Device Name: Synthes Rapid Resorbable Tack System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 2, 2005 Received: March 3, 2005

Dear Ms. Musgnung:

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 vour 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.

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## Page 2 - Ms. Musgnung

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualice of a substant as with other requirements
mean that FDA has made a determination that your device cod by ather Foderal agencies mean that FDA nas made a decemmandin and your and your and limited to: posicties.
of the Act or any Federal statutes and regulations administered to: positively of the Act of of Federal statutes and regiraments, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing programs and You must comply with an the Act 3 requirements art 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), laboling (21 CFR Part 820); and 120); and if requirements as set form in the quality systems (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) I mis letter will anow you to begin mailering your substantial equivalence of your device to a premarket notification. The PDF Intellige or other of 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), II you desire specific advice for your de at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general meeting. International and Consumer Assistance at its toll-free Division of Director of Die [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Smith Michael MD

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number (if known): | K050204 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Rapid Resorbable Tack System |
| Indications: | Synthes Rapid Resorbable Tack System is intended for use in<br>fracture repair and reconstructive procedures of the craniofacial<br>skeleton. In addition, Rapid Resorbable Tacks may be used in<br>non-load bearing applications for maintaining the relative<br>position of and/or containing bony fragments, bone grafts<br>(autograft or allograft) or bone graft substitutes in reconstruction of<br>of the craniofacial or mandibular areas. |
| Contraindications: | These devices are not intended for use in load bearing<br>applications, such as the mandible, unless used in conjunction<br>with traditional rigid fixation. Synthes Rapid Resorbable Tacks<br>are not intended for areas with active or latent infection or for<br>patient conditions including limited blood supply or insufficient<br>quantity or quality of bone. These devices are not intended for<br>use in the spine. |

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

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

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## Concurrence of CDRH, Office of Device Eyaluation (ODE)
Station Sign-Off)

ision of Anesthesiology, General Hospital, Traction Control, Dental Devices

10(k) Number _________________________________________________________________________________________________________

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