(25 days)
Not Found
No
The summary describes a mechanical plating system for bone fixation and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is used for the fixation of fractures, osteotomies, and nonunions of the clavicle, which are therapeutic interventions.
No
This device is a plating system used for fixation of clavicle fractures, osteotomies, and nonunions, not for diagnosing conditions.
No
The device description explicitly states the system is comprised of plates, screws, and instruments, which are 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 nonunions of the clavicle. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and instruments used for surgical implantation. These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The A.L.P.S. Clavicle Plating System is a surgical implant system used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and nonunions of the clavice including osteopenic bone.
Product codes
HRS
Device Description
The A.L.P.S. Clavicle Plating System is designed to address fractures of the clavicle. The system is comprised of plates, screws, and instruments to facilitate the installation of the implants.
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
Prescription Use
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:
- Guide Comparison o
- Drilling Test O
Clinical Tests:
- o NA
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
February 19, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biomet Inc. Kyle Ponce Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K210192
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: January 22, 2021 Received: January 25, 2021
Dear Kyle Ponce:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K210192
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 nonunions of the clavice including 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)
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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: | Kyle Ponce
Regulatory Affairs Specialist
Telephone: (908-839-9069)
Fax: (574-372-1718) | | | |
| Date: | January 22, 2021 | | | |
| 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): | K173767 | A.L.P.S. Clavicle Plating System
Biomet Inc. | | |
| Purpose and Device
Description: | The purpose of this submission is to identify the design
changes made to the A.L.P.S. Clavicle 2.2/2.7mm Soft
Tissue Guide to improve the safety and effectiveness of
the device. | | | |
| | The A.L.P.S. Clavicle Plating System is designed to
address fractures of the clavicle. The system is comprised
of plates, screws, and instruments to facilitate the
installation of the implants. | | | |
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K210192 Page 2 of 2
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 nonunions of the clavicle including osteopenic bone.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- . Intended Use: Same as the predicate device.
- Indications for Use: Same as the predicate device. ●
- Materials: Same as the predicate device. ●
- Design Features: Same as the predicate device. ●
- Sterilization: Same as the predicate device. .
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests:
- Guide Comparison o
- Drilling Test O
- Clinical Tests:
- o NA
Substantial Equivalence Conclusion
The information provided within this submission demonstrates that the A.L.P.S. Clavicle Plating System is substantially equivalent to the predicate device.