Arthrex Plates, Screws, and Staples

K150456 · Arthrex, Inc. · HRS · Apr 29, 2015 · Orthopedic

Device Facts

• Record ID: K150456
• Device Name: Arthrex Plates, Screws, and Staples
• Applicant: Arthrex, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 29, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws which join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization. The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of proximal fractures of the humerus. The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition, and stabilize metatarsus primus varus. The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone. The Arthrex Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand and wrist, such as opening wedge osteotomies of Hallux Valgus. The Arthrex Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. The system can be used for palmar, dorsal or orthogonal application. The Arthrex Compression FT Screw is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Osteochondral fragments (talar vault, femoral condyle)Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)Cancellous fragments (talus)Carpal, metacarpal, and small hand boneTarsal and metatarsalsPhalangesIntra-articular fracturesAnkleProximal and distal humerusProximal and distal radiusProximal and distal ulnaOsteochondral fixation and fracturesOsteochondritis DissecansFixation of fractures and osteotomies about the kneeOblique fractures of the fibulaReconstructive surgeries of the footMalleolar fixation

Device Story

Family of metallic plates, screws, and staples for orthopedic internal fixation; manufactured from stainless steel or titanium. Used by surgeons in clinical settings to stabilize fractures, osteotomies, and fusions. Devices provide mechanical support to bone fragments during healing; intended for use with post-operative immobilization. Submission addresses addition of sterile packaging options via Gamma Irradiation or Ethylene Oxide (EO) sterilization for previously cleared non-sterile devices.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and intended use similarity to predicates, with validation of sterilization processes.

Technological Characteristics

Metallic bone fixation appliances (plates, screws, staples) made of stainless steel or titanium. Available in various sizes. Sterilization via Gamma Irradiation or Ethylene Oxide.

Indications for Use

Indicated for internal bone fixation, stabilization of fractures, osteotomies, joint fusions, and reconstruction of bone fragments in the humerus, tibia, femur, hand, wrist, foot, and ankle. Includes treatment of non-union, malunion, and osteopenic bone.

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

• Arthrex Modified Osteotomy System (K014155)
• Arthrex Humeral Fracture Plates & Screws (K041965)
• Arthrex Compression Staple (K080111)
• Arthrex Distal Extremity Plate System (K111253)
• Arthrex Compression Plates (K130510)
• Arthrex Distal Radius Plate System (K131474)
• Arthrex Compression FT Screws (K132217)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.

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

April 29, 2015

Arthrex Inc. Mr. David L. Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K150456 Trade/Device Name: Arthrex Plates, Screws, and Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, JDR Dated: April 7, 2015 Received: April 8, 2015

Dear Mr. David L. Rogers:

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. 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 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 - Mr. David L. Rogers

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely vours.

## Mark N. Melkerson -S

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

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150456

Device Name Arthrex Plates, Screws, and Staples

## Indications for Use (Describe)

The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws which join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization.

The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of proximal fractures of the humerus.

The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition, and stabilize metatarsus primus varus.

The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, osteotomies, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.

The Arthrex Compression Plates are intended to be used for internal bone fractures, fusions, or osteotomies in the ankle, foot, hand and wrist, such as opening wedge osteotomies of Hallux Valgus.

The Arthrex Distal Radius Plate System is internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.

The Arthrex Compression FT Screw is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Osteochondral fragments (talar vault, femoral condyle); Apical fragments (radial head, patellar, metacarpal/metatarsal); Cancellous fragments (talus); Carpal, metacarpal, and small hand bone; Tarsal and metatarsals; Phalanges; Intra-articular fractures; Ankle: Proximal and distal humerus: Proximal and distal radius: Proximal and distal ulna: Osteochondral fixation and fractures; Osteochondritis Dissecans; Fixation of fractures about the knec; Oblique fractures of the floula; Reconstructive surgeries of the foot; Malleolar fixation

Type of Use (Select one or both, as applicable)

* | Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | April 9, 2015 |
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | David L Rogers<br>Regulatory Affairs Associate<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 71924<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Plates, Screws, and Staples |
| Common Name | Plate, fixation, bone, staple |
| Product Code -Classification Name<br>CFR | HRS - Plate, Fixation, Bone<br>HWC - Screw, Fixation, Bone<br>JDR - Single/multiple component metallic bone<br>fixation appliances and accessories<br>21 CFR 888.3030: Single/multiple component metallic<br>bone fixation appliances and accessories<br>21 CFR 888.3040: Smooth or threaded metallic bone<br>fixation fastener |
| Predicate Device | K014155: Arthrex Modified Osteotomy System<br>K041965: Arthrex Humeral Fracture Plates & Screws<br>K080111: Arthrex Compression Staple<br>K111253: Arthrex Distal Extremity Plate System<br>K130510: Arthrex Compression Plates<br>K131474: Arthrex Distal Radius Plate System<br>K132217: Arthrex Compression FT Screws |
| Purpose of Submission | This special 510(k) premarket notification is intended<br>to address the use of Gamma Irradiation and Ethylene<br>Oxide sterilization on the Arthrex Plates, Screws, and<br>Staples devices, which were originally cleared as non-<br>sterile devices under K014155, K041965, K080111,<br>K111253, K130510, K131474, K132217. The intended<br>use, material, and fundamental technological<br>characteristics of the proposed Arthrex Plates, Screws,<br>and Staples are substantially equivalent to the non-<br>sterile predicates. |
| Device Description | The Arthrex Plates, Screws, and Staples is a family of |
| | plates, screws, and staples manufactured from<br>stainless steel or titanium that will be offered as sterile<br>or non-sterile devices in various sizes for use in<br>orthopedic surgery. |
| Intended Use | The Arthrex Modified Osteotomy System, designed for<br>Opening Wedge Distal Tibial, Distal Femoral, Proximal<br>Tibial osteotomies, and High Tibial Closing<br>Osteotomies, is used in conjunction with bone screws<br>to provide fixation following surgery. Specifically for<br>use in treatment of non-union, malunion, and<br>fractures of proximal tibia, distal femur, and distal<br>tibia including simple, comminuted, lateral wedge,<br>depression, medial wedge, bicondylar, combinations of<br>lateral wedge and depression, and fractures with<br>associated shaft fractures. Specially sloped plates can<br>be used in cases when a tibial slope adjustment is<br>needed. This system consists of plates and screws<br>which join together to correct abnormalities or trauma<br>related injuries. It is intended to be used with<br>adequate post-operative immobilization. |
| | The Arthrex Humeral Fracture Plates and Screws are<br>intended to provide internal fixation of proximal<br>fractures of the humerus. |
| | The Arthrex Compression Staple is intended to be used<br>for fixation such as: LisFranc arthrodesis, mono or bi-<br>cortical osteotomies in the forefoot, first<br>metatarsophalangeal arthrodesis, Akin osteotomy,<br>midfoot and hindfoot arthrodesis or osteotomies,<br>fixation of osteotomies for hallux valgus treatment<br>(Scarf and Chevron), and arthrodesis of the<br>metatarsocuneiform joint to reposition, and stabilize<br>metatarsus primus varus. |
| | The Arthrex Distal Extremity Plate System is intended<br>for use in stabilization of fresh fractures, revision<br>procedures, osteotomies, joint fusion and<br>reconstruction of small bones and bone fragments of<br>the hand/wrist, foot/ankle, and osteopenic bone. |
| | The Arthrex Compression Plates are intended to be<br>used for internal bone fixation for bone fractures,<br>fusions, or osteotomies in the ankle, foot, hand and<br>wrist, such as opening wedge osteotomies of Hallux<br>Valgus. |
| | The <b>Arthrex Distal Radius Plate System</b> is intended for<br>internal fixation for fractures and reconstruction of the<br>small bones, primarily including the distal radius and<br>distal ulna. Examples of these internal fixations and<br>reconstructions include compression fractures, intra-<br>articular and extra-articular fractures, displaced<br>fractures, osteotomies, non-unions and malunions.<br>The system can be used for palmar, dorsal or<br>orthogonal application.<br><br>The <b>Arthrex Compression FT Screw</b> is intended for<br>fixation of small bone fragments, such as apical<br>fragments, osteochondral fragments and cancellous<br>fragments. Specific applications include the following:<br>Osteochondral fragments (talar vault, femoral<br>condyle)Apical fragments (radial head, patellar rim,<br>navicular, metacarpal/metatarsal)Cancellous fragments (talus)Carpal, metacarpal, and small hand boneTarsal and metatarsalsPhalangesIntra-articular fracturesAnkleProximal and distal humerusProximal and distal radiusProximal and distal ulnaOsteochondral fixation and fracturesOsteochondritis DissecansFixation of fractures and osteotomies about<br>the kneeOblique fractures of the fibulaReconstructive surgeries of the footMalleolar fixation |
| Substantial Equivalence Summary | The <b>Arthrex Plates, Screws, and Staples</b> is<br>substantially equivalent to the predicate devices in<br>which the basic design features and intended uses are<br>the same. Any differences between the <b>Arthrex<br/>Plates, Screws, and Staples</b> and the predicates are<br>considered minor and do not raise questions<br>concerning safety and effectiveness.<br><br>All devices subject to this submission were previously<br>cleared as non-sterile devices. The proposed devices<br>will undergo Gamma Irradiation or Ethylene Oxide |
| (EO) sterilization. | |
| Based on the indications for use, technological<br> characteristics, and the summary of data submitted,<br> Arthrex, Inc. has determined that the Arthrex Plates,<br> Screws, and Staples is substantially equivalent to the<br> predicates. | |

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