K Number
K143385
Device Name
Acumed Ankle Plating System
Manufacturer
Date Cleared
2015-04-06

(131 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acumed Ankle Plating System is intended for fixation of fractures, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.
Device Description
The Acumed Ankle Plating System consists of plates and accompanying screws implanted in the distal fibula and tibia. The plates are available in a variety of sizes and use a variety of screw sizes to accommodate varying patient anatomies and fracture patterns. All plates are anatomically pre-contoured, and are provided in left and right limb-specific options where applicable. All implants are manufactured from Ti-6Al-4V per ASTM F136 and provided both sterile and non-sterile. The system contains precontoured plates, 2.7, 3.5, and 4.0mm screws, syndesmosis targeting instrumentation, and other typical instrumentation for ankle plating cases.
More Information

Not Found

No
The device description focuses on mechanical components (plates, screws, instrumentation) and their material properties. There is no mention of software, algorithms, image processing, or terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.

No
This device is an implantable plating system for orthopedic fixation, not a device that directly provides therapy.

No
The device is described as an implantable system for fracture fixation, not for diagnosing conditions.

No

The device description clearly states it consists of plates and screws implanted in the distal fibula and tibia, which are physical hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "fixation of fractures, and non-unions of the distal tibia and fibula". This describes a surgical implant used to stabilize bone, not a test performed on samples taken from the body.
  • Device Description: The description details plates and screws made of titanium, designed for surgical implantation. This is consistent with a medical device used in surgery, not an IVD.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening

The Acumed Ankle Plating System is a surgical implant used to treat bone fractures.

N/A

Intended Use / Indications for Use

The Acumed Ankle Plating System is intended for fixation of fractures, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

Product codes

HRS, HWC

Device Description

The Acumed Ankle Plating System consists of plates and accompanying screws implanted in the distal fibula and tibia. The plates are available in a variety of sizes and use a variety of screw sizes to accommodate varying patient anatomies and fracture patterns. All plates are anatomically pre-contoured, and are provided in left and right limb-specific options where applicable. All implants are manufactured from Ti-6Al-4V per ASTM F136 and provided both sterile and non-sterile. The system contains precontoured plates, 2.7, 3.5, and 4.0mm screws, syndesmosis targeting instrumentation, and other typical instrumentation for ankle plating cases.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

distal tibia and fibula

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Comparative testing between the Acumed Ankle Plating System and a predicate device was conducted per ASTM F382-99. The test data showed the Acumed Ankle Plating System was substantially equivalent to the predicate device in both static four-point bend and bending fatigue tests as described herein.

Key Metrics

Not Found

Predicate Device(s)

K011335, K120854, K083213

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.

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

April 6, 2015

Acumed, LLC Mr. Nathan Wolf Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124

Re: K143385

Trade/Device Name: Acumed Ankle Plating System 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 Dated: March 4, 2015 Received: March 6, 2015

Dear Mr. Wolf:

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143385

Device Name Acumed Ankle Plating System

Indications for Use (Describe)

The Acumed Ankle Plating System is intended for fixation of fractures, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

Contact Details

| Applicant Name: | Acumed LLC
5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432 |
|-----------------|--------------------------------------------------------------------------------------------------------|
| | Nathan Wolf, Regulatory Specialist
503-726-6622 (Cell)
503-207-1502 (Desk)
503-520-9618 (Fax) |
| Date Prepared: | 24 November 2014 |

Device Name

  • Trade Name: Acumed Ankle Plating System
    Common Name: Ankle Plating System

21 CFR 888.3030 Single/multiple component metallic bone fixation Classification: appliances and accessories

Class: Class II

HRS. HWC Product Code:

Legally Marketed Predicate Device(s)

The Synthes Third Tubular Plate (pre-amendment per K011335), Synthes VA LCP Ankle Trauma System cleared in 2012 (K120854), and the Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates cleared in 2008 (K083213) serve as the predicate devices.

Device Description

The Acumed Ankle Plating System consists of plates and accompanying screws implanted in the distal fibula and tibia. The plates are available in a variety of sizes and use a variety of screw sizes to accommodate varying patient anatomies and fracture patterns. All plates are anatomically pre-contoured, and are provided in left and right limb-specific options where applicable. All implants are manufactured from Ti-6Al-4V per ASTM F136 and provided both sterile and non-sterile. The system contains precontoured plates, 2.7, 3.5, and 4.0mm screws, syndesmosis targeting instrumentation, and other typical instrumentation for ankle plating cases.

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Intended Use/Indications for Use

The Acumed Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

Substantial Equivalence Comparison

In consideration of the comparisons given herein, the Acumed Ankle Plating System has been determined to be substantially equivalent to its predicate devices, the Synthes Third Tubular Plates (pre-amendment), Synthes VA LCP Ankle Trauma System (K120854), and Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates (K083213). Substantial equivalence was determined due to similarities in materials, technology, function, and dimensions.

Non-clinical Testing

Comparative testing between the Acumed Ankle Plating System and a predicate device was conducted per ASTM F382-99. The test data showed the Acumed Ankle Plating System was substantially equivalent to the predicate device in both static four-point bend and bending fatigue tests as described herein.