BIOMET CALCANEAL PLATE

K022515 · Biomet Orthopedics, Inc. · HRS · Sep 17, 2002 · Orthopedic

Device Facts

• Record ID: K022515
• Device Name: BIOMET CALCANEAL PLATE
• Applicant: Biomet Orthopedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Intra-articular fractures of the calcaneus 2) Extra-articular fractures of the calcaneus and 3) Osteotomies of the calcaneus.

Device Story

Biomet Calcaneal Plate is an open-structure bone plate with a central cross-strut; manufactured from 316 LVM stainless steel. Device features 11 or 13 screw holes for 3.5mm cortical screw fixation. Design is universal for left or right foot application; available in small, large, and extra-large sizes. Plate is slightly malleable for anatomical contouring and can be cut intraoperatively by the surgeon to achieve optimal fit. Used in orthopedic surgery for bone fixation; provides structural support to stabilize fractures or osteotomy sites during healing.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Material: 316 LVM stainless steel. Design: Open structure with central cross-strut; 11 or 13 screw holes for 3.5mm cortical screws. Form factor: Universal left/right design; three sizes (small, large, extra-large). Malleable for anatomical contouring; cuttable intraoperatively.

Indications for Use

Indicated for patients requiring fixation for intra-articular calcaneal fractures, extra-articular calcaneal fractures, or calcaneal osteotomies.

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

• Synthes Calcaneal Plate (K991407, K010518, K020401)
• Kirschner Small Fragment Fixation System (K864924)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

Applicant/Sponsor:Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

SFP 1 7 2002

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist Telephone: [phone] Fax: [phone]

Proprietary Name: Biomet Calcaneal Plate

Common Name: Bone Plate

Classification Name: Single/multiple component, metallic, bone fixation appliances and accessories.

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- Synthes Calcaneal Plate (K991407, K010518, K020401) .
- Kirschner Small Fragment Fixation System (K864924) .

Device Description: The Biomet Calcaneal Plate is an open structure bone plate with a cross-strut in the center manufactured from 316 LVM Stainless Steel. The device has 11 or 13 screw holes, depending on plate size, to ensure bone purchase of screws. The devices is slightly malleable, to conform to each patient's anatomy at the time of surgery. The device can also be cut in the operating room it achieve better fit.

The device is universal in design and therefore may be used on either the right or left foot. Three sizes are available, small, large and extra-large. A series of 3.5mm cortical screws are used in conjunction with the device.

Intended Use: 1) Intra-articular fractures of the calcaneus 2) Extra-articular fractures of the calcaneus and 3) Osteotomies of the calcaneus.

Summary of Technologies: The materials, surface finishes and processing of the device are similar to the predicate devices.

Non-Clinical and Clinical Testing: None provided

MAHING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - -

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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OFFICE -574.267.6639

FAX [phone]

E-MAIL [e-mail]

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Orthopedics, Inc. Patricia Sandborn Beres Senior Regulatory Specialist P. O. Box 587 Warsaw, Indiana 46581-0587

Re: K022515

Trade/Device Name: Biomet Calcaneal Plate Regulation Number: 888.3030 Regulation Name: Single/multiple component, metallic, bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 29, 2002 Received: July 30, 2002

Dear Ms. Beres:

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 (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.

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Page 2 - Ms. Patricia Sandborn Beres

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N. Milliman

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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510(k) Number (if known): k022515

Device Name: Biomet Calcaneal Plate

Indications For Use:

- Intra-articular fractures of the calcaneus .
- Extra-articular fractures of the calcaneus ●
- Osteotomies of the calcaneus .

Mark A Milkersm

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K022515

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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