BIOMET VISION FOOTRING SYSTEM

K093057 · Ebi, L.P. · KTT · Dec 1, 2009 · Orthopedic

Device Facts

• Record ID: K093057
• Device Name: BIOMET VISION FOOTRING SYSTEM
• Applicant: Ebi, L.P.
• Product Code: KTT · Orthopedic
• Decision Date: Dec 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet® Vision® Foot Ring System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality. Additional indications for this system include: Correction of deformity . Revision procedure where other treatments or devices have been unsuccessful . Bone reconstruction procedures . . Fusions and replantations of the foot . Charcot foot reconstruction and Lisfranc dislocations . Ankle distraction (arthrodiastasis) ●

Device Story

Biomet Vision Foot Ring System is an external fixation device for orthopedic bone conditions. It consists of metallic bone fixation appliances and accessories. Used by surgeons in clinical settings to stabilize bone segments for lengthening, reconstruction, or fusion. Operates via mechanical fixation to bone; provides structural support for healing. No software or electronic components. Benefits include stabilization of complex foot/ankle pathologies and deformity correction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation appliances and accessories. External fixation modality. Class II device under 21 CFR 888.3030. No software, electronics, or energy sources.

Indications for Use

Indicated for patients requiring external fixation for bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, deformity correction, bone reconstruction, foot fusions/replantations, Charcot foot reconstruction, Lisfranc dislocations, and ankle distraction (arthrodiastasis), including revision procedures.

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

• Stryker Hoffman II Foot Ring (K041706)
• SBi RingFIX™ System (K071394)

Submission Summary (Full Text)

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**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 a bold, sans-serif font with a unique design where the letters are connected and have a three-dimensional appearance. Below "BIOMET" is the word "TRAUMA" in a smaller, simpler sans-serif font.

# DEC - 1 2009

11 093057

### 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:

Biomet Trauma 100 Interpace Parkway Parsippany, NJ 07054

2242816

Establishment Registration Number:

Contact:

Margaret F. Crowe Regulatory Affairs Project Manager Biomet Trauma 100 Interpace Parkway Parsippany, NJ 070654 Tel .: [phone], ext. 2260 Fax: [phone] E-mail: [e-mail]

October 29, 2009 Date Prepared: Biomet® Vision® Foot Ring System Trade/Proprietary Name: External Fixation Device Common/Usual Name:

Single/multiple metallic bone fixation appliances and Classification Name: accessories (21 CFR 888.3030)

Orthopedics KTT Device Panel/Product Code:

#### Device Description:

Device Desertification. and K052239.

#### Indications for Use:

The indications for this system have been modified. The Biomet® Vision® Foot Ring System is intended for use in the treatment of bone conditions including leg

Plof 2
Page 5.2

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#### Biomet Trauma Traditional 510(k) Premarket Notification

lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.

Additional indications for this system include:

- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Bone reconstruction procedures .
- . Fusions and replantations of the foot
- Charcot foot reconstruction and Lisfranc dislocations .
- Ankle distraction (arthrodiastasis) ●

The Biomet Vision FootRing System is substantially equivalent to other legally marketed devices, including the Stryker Hoffman II Foot Ring (cleared under premarket notification K041706), and the SBi RingFIX™ System (cleared under premarket notification K071394).

Operational principles for the device are unchanged.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Biomet Trauma % Ms. Margaret Crowe Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054

DEC - 1 2009

Re: K093057

Trade/Device Name: Biomet® Vision® Foot Ring System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: November 20, 2009 Received: November 23, 2009

Dear Ms. Crowe:

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. Ilsting 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

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Page 2 - Ms. Margaret Crowe

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.

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.

Sincerely vours.

Jonetta B

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

Enclosure

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## Indications for Use

510(k) Number (if known): 1093054

Device Name: Biomet® Vision® Foot Ring System

The Biomet® Vision® Foot Ring System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.

Additional indications include:

- Correction of deformity .
- Revision procedures where other treatments or devices have been unsuccessful .
- Bone reconstruction procedures .
- Fusions and replantations of the foot .
- Charcot foot reconstruction and Lisfranc dislocations
- Ankle distraction (arthrodiastasis)

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)

Temperature

Soutu for mxn

(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K093057