(23 days)
The Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
The Synthes Sterile Mandible External Fixator Kit consist of a 4.0 mm Titanium Straight Rod and a bending template to be used in conjunction with the Synthes Mandible External Fixator.
The provided text pertains to the FDA 510(k) submission for the "Synthes Sterile Mandible External Fixator Kit" and its predicate device, the "Synthes Mandible External Fixator." This document is a regulatory approval summary and does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document primarily focuses on:
- Identifying the sponsor, device name, classification, and predicate device.
- Describing the device and its intended use.
- Stating that information presented supports substantial equivalence to the predicate device.
- Providing the FDA's decision regarding substantial equivalence for marketing the device.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) from this document. This kind of information would typically be found in a separate clinical or performance study report or detailed validation documentation submitted as part of the 510(k), which is not present here.
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3.0 510(k) Summary
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| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940 |
|---|---|
| Device Name: | Synthes Sterile Mandible External Fixator Kit |
| Classification: | 21 CFR 872.4760: Bone Plate |
| Predicate Devices: | Synthes Mandible External Fixator |
| Device Description: | The Synthes Sterile Mandible External Fixator Kit consist of a 4.0mm Titanium Straight Rod and a bending template to be used inconjunction with the Synthes Mandible External Fixator. |
| Intended Use: | The Synthes Mandible External Fixator is intended to stabilize andprovide treatment for fractures of the maxillofacial area, includingsevere open mandibular fractures, highly comminuted closedfractures, nonunions and delayed unions (especially associatedwith infection), fractures associated with infections, tumorresections, facial deformity corrections, gunshot wounds, pan facialfractures, burn maintenance, and bone grafting defects. |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
090005
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2006
Mr. Shari L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K062299
Trade/Device Name: Synthes Mandible External Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: August 7, 2006 Received: August 8, 2006
Dear Mr. 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 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.
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Page 2 - Mr. Musgnung
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.
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 vour 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 Office of Compliance at (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ques
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):
Device Name:
Synthes Mandible External Fixator
Indications for Use:
The Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
X Prescription Use (Per 21 CFR 801.109)
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)
| (Division Sign-Off) |
|---|
| Division of Anesthesiology, General Hospital, |
| Infection Control, Dental Devices |
| K) Number | K06229 |
|---|---|
| ----------- | -------- |
0000042.0
§ 872.4760 Bone plate.
(a)
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.(b)
Classification. Class II.