(116 days)
Not Found
No
The description focuses on the mechanical aspects of a bone plating system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "A.L.P.S. Clavicle Plating System" that provides "fixation of fractures, osteotomies and non-unions of the clavicle." This indicates its use in treating and correcting medical conditions, aligning with the definition of a therapeutic device.
No
Explanation: The device description and intended use clearly state that the A.L.P.S. Clavicle Plating System is used for fixation of fractures, osteotomies, and non-unions of the clavicle, which are treatment-oriented functions, not diagnostic ones. It is a surgical implant system.
No
The device description explicitly states the system is comprised of plates and instruments, 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, osteotomies and non-unions of the clavicle". This describes a surgical procedure to repair bone, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "Clavicle Plating System" comprised of "plates and instruments". These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant and instrument system.
N/A
Intended Use / Indications for Use
The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and non-unions of the clavice including osteopenic bone.
Product codes
HRS
Device Description
The purpose of this submission is to request clearance for the new A.L.P.S Clavicle Plating System. The A.L.P.S Clavicle Plating System implants are designed to address fractures of the clavicle. The system is comprised of plates and instruments to facilitate the installation of the implants. The plates are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
- Construct Static Testing
- Galvanic Corrosion Evaluation
Clinical Tests:
- N/A
Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.
April 6, 2018
Biomet Inc. Dhaval Saraiya Regulatory Affairs Sr. Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K173767
Trade/Device Name: A. L. P. S. Clavicle 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 Dated: March 22, 2018 Received: March 23, 2018
Dear Dhaval Saraiya:
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 of medical device-related adverse events) (21 CFR 803); 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K173767
Device Name A.L.P.S. Clavicle Plating System
Indications for Use (Describe)
The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and non-unions of the clavice including osteopenic bone.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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K173767
PAGE 1 OF 3
510(k) Summary
In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the A.L.P.S. Clavicle Plating System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------|
| Contact Person: | Dhaval Saraiya
Regulatory Affairs Sr. Specialist
Telephone: (305-269-6386)
Fax: (305-269-6400) | | |
| Date: | March 22nd, 2018 | | |
| Subject Device: | Trade Name: A.L.P.S. Clavicle Plating System
Common Name: Plate, Fixation, Bone | | |
| | Classification Name:
• HRS - Single/multiple component metallic bone
fixation appliances and accessories (21 CFR 888.3030) | | |
| Predicate Device(s): | K083843 | Locking Anatomic
& Composite
Plating System | Depuy
Orthopaedics* |
| * The predicate device is included in Biomet's current product
portfolio. Biomet acquired DePuy Trauma and as a result of the
acquisition of DePuy Trauma, Biomet is now the owner of the
predicate device 510(k). | | | |
| Purpose and Device
Description: | The purpose of this submission is to request clearance for
the new A.L.P.S Clavicle Plating System. The A.L.P.S
Clavicle Plating System implants are designed to address
fractures of the clavicle. The system is comprised of plates
and instruments to facilitate the installation of the
implants. The plates are manufactured from Titanium
Alloy per ASTM F136. Implants and instruments will be | | |
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provided in non-sterile configuration and will require steam sterilization prior to use.
Intended Use and Indications for Use:
Summary of Technological Characteristics:
The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The intended use is similar to the ● intended use cleared in K083843.
- Indications for Use: The indications for use are ● similar to the indications for use cleared in K083843.
- Materials: The new A.L.P. S. Clavicle Plating System ● plates are manufactured from Titanium Alloy (per ASTM F136). Implant grade titanium alloys are commonly used materials in orthopedic implants.
- Design Features: The design features for new ● A.L.P. S. Clavicle Plating System is similar to those in currently marketed devices cleared in K083843. The design differences have not identified any issues that would impact the safety and effectiveness of the device.
- Sterilization: The implants and instruments are offered to the user in the non-sterile configuration. The non-sterile implants and instruments will be required to be steam sterilized by the user prior to use. The nonsterile packaging configuration is similar to the predicate devices currently marketed and cleared via K083843.
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: ●
- Construct Static Testing o
- Galvanic Corrosion Evaluation O
- Clinical Tests:
- o N/A
Substantial Equivalence
5
Conclusion
The A.L.P.S. Clavicle Plating System has shown to be substantially equivalent to the predicate device. Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.