2.5MM INLINE FUSION PLATE

K131867 · Biomet, Inc. · HRS · Oct 29, 2013 · Orthopedic

Device Facts

• Record ID: K131867
• Device Name: 2.5MM INLINE FUSION PLATE
• Applicant: Biomet, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Device Story

ALPS 2.5mm Inline Fusion Plate is a metallic bone fixation system. Device consists of 2.5mm titanium alloy plate used with non-locking, locking, and variable angle screws (titanium alloy and CoCr). Used by surgeons for stabilization and fixation of fractures, fusions, revisions, and reconstructions in various skeletal sites including hand, foot, wrist, ankle, and pelvis. Implant provides mechanical support to bone segments to facilitate healing. Benefit includes stabilization of bone, particularly in osteopenic bone. Device is used in clinical/surgical settings.

Clinical Evidence

Bench testing only. Evidence includes axial load construct testing and evaluation of galvanic corrosion potential.

Technological Characteristics

2.5mm titanium alloy plate; screws manufactured from titanium alloy and CoCr. Design, dimensions, and materials are similar to predicate systems. Mechanical fixation device.

Indications for Use

Indicated for stabilization and fixation of fractures, revisions, fusions, reconstructions (osteotomy), and non-unions of bones in hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula, and pelvis. Suitable for adults and adolescents (>12-21 years) with osteopenic bone. Contraindicated in skeletally immature patients where implants cross open epiphyseal plates.

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

• Fracture and Fusion Plating System (K093474)
• Mini Fragment Plating System (K061748)

Submission Summary (Full Text)

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## Section 5 — 510(k) Summary

| Submitted by: | Biomet Trauma<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone]<br>OCT 2 9 2013 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Suzana Otaño, Global Project Manager, Regulatory Affairs |
| Date Prepared: | June 17, 2013 |
| Proprietary Name: | ALPS 2.5mm Inline Fusion Plate |
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories (21 CFR § 888.3030) |
| Predicate Devices: | The ALPS 2.5mm Inline Fusion Plate is substantially equivalent to<br>currently marketed Fracture and Fusion Plating System (K093474)<br>and the Mini Fragment Plating System (K061748). |
| Device Description: | The ALPS 2.5mm Inline Fusion Plate consists of a 2.5mm Titanium<br>alloy fusion plate offered to be used with non-locking, locking and<br>variable angle screws manufactured from Titanium alloy and CoCr<br>for bone fixation and the management of fractures, fusions,<br>revisions and reconstructive surgeries. |
| Indications for Use: | The system is intended for use in stabilization and fixation of<br>fractures, revision procedures, fusions, reconstructions (osteotomy)<br>and non-unions of the bones of the hand, foot, wrist, ankle, finger,<br>toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in<br>osteopenic bone. The system can be used in both adult and<br>pediatric patients (adolescents [>12 - 21 years of age]), where the<br>implant would not cross open epiphyseal plates in skeletally<br>immature patients. |
| Technological<br>Characteristics: | The technological characteristics of the ALPS 2.5mm Inline Fusion<br>Plate are similar to the predicate devices including design,<br>dimensions and material. |

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# K131867 page 1 of 2

Summary of Substantial Equivalence:

The ALPS 2.5mm Inline Fusion Plate is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data including axial load construct testing and evaluation of galvanic corrosion potential. No new issues of safety or efficacy have been raised.

ALPS 2.5mm Inline Fusion Plate - Traditional 510(k) - Amended Biomet Trauma

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol to the right, consisting of three curved lines that resemble a human form. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2013

Biomet, Inc. Ms. Suzana Otaño Global Project Manager, Regulatory Affairs 56 East Bell Drive P.O. Box 587 Warsaw. Indiana 46581

Re: K131867

Trade/Device Name: ALPS 2.5mm Inline Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Date: September 30, 2013 Received: October 1. 2013

Dear Ms. Otaño:

We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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## Page 2 - Ms. Suzana Otaño

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 (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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Ering Meith

for

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

#### Enclosure

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### SECTION 4 - INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K131867 |
|----------------|--------------------------------|
| Device Name: | ALPS 2.5mm Inline Fusion Plate |

## Indications For Use:

Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

× Prescription Use_ (Per 21 CFR 801 Subpart D)

AND/OR Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth L. Frank -S

Division of Orthopedic Devices

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