BIODRIVE CANNULATED SCREW SYSTEM

K082874 · Biomet Trauma · HWC · Feb 5, 2009 · Orthopedic

Device Facts

• Record ID: K082874
• Device Name: BIODRIVE CANNULATED SCREW SYSTEM
• Applicant: Biomet Trauma
• Product Code: HWC · Orthopedic
• Decision Date: Feb 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioDrive® Cannulated Screw System is indicated for the following: - Fixation of fractures in long bones ● - Fixation of small bones, including those in the foot, patella, ankle, wrist & elbow - Arthrodesis of the foot, wrist and elbow - Small and long bone osteotomies - Fixation of pelvis and the illiosacral joint

Device Story

BioDrive® Cannulated Screw System consists of cannulated bone screws of various diameters/lengths, optional washers, guide wires, and surgical instruments. Used by orthopedic surgeons in clinical/OR settings for bone fixation and arthrodesis. Screws provide mechanical stabilization of bone fragments or joints to facilitate healing. Device is implanted via standard surgical techniques; output is physical stabilization of the bone/joint. Benefits include rigid fixation of fractures and osteotomies.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by engineering rationale and bench testing.

Technological Characteristics

Materials: Titanium alloy (Ti-6AL-4V) per ASTM F136. Features: Cannulated design, four threaded configurations, optional acid-etched (Osseotite™) surface treatment. Includes washers, guide wires, and instrumentation. Mechanical fixation device.

Indications for Use

Indicated for fixation of long and small bone fractures (foot, patella, ankle, wrist, elbow), arthrodesis (foot, wrist, elbow), osteotomies, and fixation of the pelvis and iliosacral joint.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Propeller Head Small Cannulated Screw System (K024086)
• Acid Etched Lag Screws (K070955)
• Synthes Cannulated Screws (K012945, K021932, K040765, K962011, K963172, K962823)
• DePuy SIJF Cannulated Screw System (K051296)

Submission Summary (Full Text)

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K082874

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in
accordance with the requirements of 21 CED & 007 00 accordance with the requirements of 21 CFFR § 807 93

| Submitter: | Biomet Trauma<br>100 Interpace Parkway<br>Parsippany, NJ 07054 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 2242816 |
| Contact: | Debra L. Bing<br>Director Regulatory Affairs<br>Biomet Trauma<br>100 Interpace Parkway<br>Parsippany, NJ 070654<br>Tel.: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared:<br>Trade/Proprietary Name: | July, 18 2008<br>BioDrive® Cannulated Screw System |
| Common/Usual Name: | Bone Screw |
| Classification Name: | Screw, Fixation, Bone (888.3040) |
| Device Classification: | II |
| Predicate Device: | Propeller Head Small Cannulated Screw System<br>(K024086)<br>Acid Etched Lag Screws (K070955)<br>Synthes Cannulated Screws (K012945, K021932,<br>K040765, K962011, K963172, K962823)<br>DePuy SIJF Cannulated Screw System (K051296) |
| Non-Clinical Testing: | An engineering rationale has been prepared to<br>demonstrate substantial equivalence to similar<br>commercially available products. This engineering<br>rationale can be found in Section 18. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |
| Device Description: | The Biodrive® Cannulated Screw System consists of |

FEB -5 2009

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cannulated screws of various diameters and lengths with four threaded configurations. The system includes 3 different size washers, the use of which are optional, as well as guide wire and complete instruments. They are made from made Titanium alloy (Ti-6AL-4V) in conformance with ASTM F136 standard. The Titanium screws are also available acid etched (Osseotite™).

#### Indications for Use:

- Fixation of fractures in long bones .
- Fixation of small bones, including those in the . foot, patella, ankle, wrist & elbow
- Arthrodesis of the foot, wrist and elbow ●
- Small and long bone osteotomies .
- Fixation of pelvis and the illiosacral joint .

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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 & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is facing to the right.

#### Public Health Service

FEB - 5 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Trauma % Ms. Christina Lakin, M.S. Regulatory Consultant 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K082874

Trade/Device Name: BioDrive® Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 6, 2009 Received: January 7, 2009

Dear Ms. Lakin:

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.

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. Christina Lakin, M.S.

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 Biometrics' (OSB's) Division of Protmarket, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at iter toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Milken

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): K082874

Device Name: BioDrive® Cannulated Screw System

Indications for Use: The BioDrive® Cannulated Screw System is indicated for the following:

- Fixation of fractures in long bones ●
- Fixation of small bones, including those in the foot, patella, ankle, wrist & elbow
- Arthrodesis of the foot, wrist and elbow
- Small and long bone osteotomies
- Fixation of pelvis and the illiosacral joint

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-O)

Division of Gener !. Restorative, and Neurological Devices

510(k) Number K081874