BIODRIVE MICRO SCREW SYSTEM

K092670 · Ebi,Llc D/B/A Biomet Trauma · HRS · Nov 19, 2009 · Orthopedic

Device Facts

• Record ID: K092670
• Device Name: BIODRIVE MICRO SCREW SYSTEM
• Applicant: Ebi,Llc D/B/A Biomet Trauma
• Product Code: HRS · Orthopedic
• Decision Date: Nov 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures. Specifically: - Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, non-unions, or mal-unions - Ligament reconstruction - Osteochondritis dissecans - Arthrodesis of the foot, ankle, wrist, elbow and hand - Small bone osteotomies, including first metatarsal head osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Device Story

BioDrive Micro Screw System comprises bone screws, micro nail plates, and ancillary instruments. Used by surgeons for alignment and stabilization of small bone fractures in extremities (foot, ankle, wrist, elbow, hand). System facilitates fixation of fractures, non-unions, mal-unions, ligament reconstruction, osteochondritis dissecans, arthrodesis, and osteotomies. Operates via mechanical fixation of bone segments. Provides structural support to bone during healing process. Benefits patient by restoring bone alignment and stability.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Metallic bone fixation appliances (screws and micro nail plates). Design, material, and sizing are consistent with predicate devices. Class II medical device.

Indications for Use

Indicated for alignment and stabilization of small bone fractures in foot, ankle, wrist, elbow, and hand. Applicable for fractures, non-unions, mal-unions, ligament reconstruction, osteochondritis dissecans, arthrodesis, and osteotomies resulting from trauma, deformity, osteoarthritis, or rheumatoid arthritis.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Omnitech System (K050681)
• Self Countersinking Bone Screw (K013534)
• DynaFix Compression Bone Screw (K030706)

Submission Summary (Full Text)

{0}------------------------------------------------

Biomet Trauma Traditional 510(k) Premarket Notification

Image /page/0/Figure/1 description: The image shows the logo for Biomet Trauma. The word "BIOMET" is in large, bold, sans-serif font. Below that, the word "TRAUMA" is in a smaller, sans-serif font. The logo is in black and white.

092670

NOV 1 9 2009

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93.

Submitter:

EBI LLC d/b/a Biomet Trauma 100 Interpace Parkway Parsippany, NJ 07054

Establishment Registration 2242816 Number:

Contact:

Shikha Gola Regulatory Affairs Specialist Biomet Trauma 100 Interpace Parkway Parsippany, NJ 07054 Tel .: [phone], ext. 2070 Fax: [phone] E-mail: [e-mail]

Contract Manufacturer/Sterilizer: Biotech International 305. Allees de Craponne 13300 Salon de Provence, France Tel: [phone] Fax: [phone]

Date Prepared:

BioDrive Micro Screw System Trade/Proprietary Name:

Common/Usual Name:

Classification Name:

Plate, Fixation, Bone. 888.3030 Screw, Fixation, Bone 888.3040

Bone screw, Bone plate

November 17, 2009

Orthopedics HRS and HWC Device Panel/Product Code:

Page 52

{1}------------------------------------------------

Biomet Trauma Traditional 510(k) Premarket Notification

K092670

#### Device Description:

The Biomet BioDrive Micro Screw System consists of screws, a micro nail plate and ancillary instruments intended for surgery to aid in alignment and stabilization of fractures of small bones such as those in the foot, elbow, ankle, and hand.

### Indications for Use:

The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.

Specifically:

- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions
- Ligament reconstruction �
- Osteochondritis dissecans .
- Arthrodesis of the foot, ankle, wrist, elbow and hand �
- Small bone osteotomies, including first metatarsal head osteotomy, metatarsal . osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies

These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

#### Summary of Technology:

The technological characteristics (material, design, and sizing) of the implants and instruments comprising the BioDrive Micro Screw System are the same as or similar to the predicate devices.

### Substantial Equivalence:

The Biomet BioDrive bone screw system is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safectiveness. Examples of predicates include the Omnitech System distributed by TriMed Inc (K050681), the Sclf Countersinking Bone Screw distributed by Biomet (K013534) and the DynaFix Compression Bone Screw distributed by Biomet Trauma (K030706).

Page. 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

EBI LLC D/B/A Biomet Trauma % Ms. Shikha Gola 100 Interpace Parkway Parsippany, New Jersey 07054

NOV 1 9 2009

Re: K092670

Trade/Device Name: BioDrive Micro Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 28, 2009

Received: August 31, 2009

Dear Ms. Gola:

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 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 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.

{3}------------------------------------------------

Page 2- Ms. Shikha Gola

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/CDRH/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/ResourcesforYou/Industry/default.htm.

en

Sincerely yours,

Oneta 3
Mark N. Miller

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: BioDrive Micro Screw System

The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.

Specifically:

- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions
- Ligament reconstruction 아
- Osteochondritis dissecans 0
- Arthrodesis of the foot, ankle, wrist, elbow and hand 0
- Small bone osteotomies, including first metatarsal head osteotomy, metatarsal 0 osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies

These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

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)

Sonita for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092670

P2