MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM

K042986 · Synthes (Usa) · GXR · Nov 17, 2004 · Neurology

Device Facts

• Record ID: K042986
• Device Name: MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
• Applicant: Synthes (Usa)
• Product Code: GXR · Neurology
• Decision Date: Nov 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Story

Synthes Low Profile Neuro System consists of burr hole covers of various sizes designed for fixation in midface, craniofacial, and orthognathic surgical procedures. Device features low plate and screw head profile to minimize prominence. System utilizes previously cleared 1.6 mm or 1.9 mm emergency self-tapping and self-drilling screws for attachment. Used by surgeons in clinical settings to stabilize bone segments during trauma repair or reconstructive surgery. Output is physical fixation of bone; assists in structural restoration of craniofacial skeleton.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Burr hole covers with low-profile design. Utilizes 1.6 mm or 1.9 mm emergency self-tapping and self-drilling screws. Mechanical fixation device. No software or electronic components.

Indications for Use

Indicated for patients requiring fixation in selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla and chin.

Regulatory Classification

Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Predicate Devices

• Synthes Low Profile Neuro System (K042986)

Submission Summary (Full Text)

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510(k) Summary

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:

K042986

## NOV 17 2004

Page _________________________________________________________________________________________________________________________________________________________________________

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Low Profile Neuro System |
| Classification: | 21 CFR 882.5250: Cover, Burr Hole |
| Predicate Devices: | Synthes Low Profile Neuro System |
| Device Description: | The Synthes 1.6 mm burr hole covers come in various sizes to<br>accommodate various fracture and osteotomy sites, have a low<br>plate/screw head profile and use existing (previously cleared) 1.6<br>mm or 1.9 mm emergency self-tapping & self-drilling screws. |
| Intended Use: | The Synthes Low Profile Neuro System is intended for use in<br>selective trauma of the midface and craniofacial skeleton;<br>craniofacial surgery; reconstructive procedures; and selective<br>orthognathic surgery of the maxilla and chin. |
| Substantial<br>Equivalence: | Comparative information presented supports substantial<br>equivalence. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2004

Ms. Lisa Boyle Regulatory Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K042986

Trade/Device Name: Synthes (USA) Low Profile Neuro System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr hole cover Regulatory Class: II Product Code: GXR, HRS Dated: October 28, 2004 Received: October 29, 2004

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn o re(s) presses is substantially equivalent (for the indications relerenced above and nave decembers and a marketed predicate devices marketed in interstate for use stated in the encrosure) to regard to the Medical Device Amendments, or 10 commerce provision to May 20, 1976, the enaounce with the provisions of the Federal Food, Drug. devices that have been recidisention in acceraapproval of a premarket approval application (PMA). allo Cosmetic Act (1101) that do novice, subject to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified (see above) and existing major regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the over concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I DTT of ibstantes over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any it call 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 CI IC Far 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality by systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Lisa Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yours over finding of substantial equivalence of your device to a legally promative headler 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 ir you usen of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisoraliding of Yelerenes to pur responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milkeum

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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Indications for Use

510(k) Number (if known):

Device Name:

Synthes (USA) Low Profile Neuro System

Indications for Use:

The Synthes Cranial Plates are intended for use in selective trauma of the midface and The Synthes Cranial Plates are intended for use in sersen of selective orthognathic surgery of the maxilla and chin.

Prescription Use_ X (Per 21 CFR 801.109) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mullens

Same Division of General, Restorative, and Neurological Devices

510(k) Number K04298

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