(278 days)
Not Found
No
The summary describes a mechanical plating system and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are focused on mechanical properties.
Yes
The device is indicated for bone fractures and osteotomies, which are medical conditions that the device is intended to treat.
No
Explanation: The ALPHALOK™ Plating System is used for treating bone fractures and osteotomies by providing plates and screws for fixation. It is a treatment device, not a diagnostic device.
No
The device description explicitly states it consists of bone plates and screws made of titanium, and requires specific instrumentation made of stainless steel. These are physical hardware components, not software.
Based on the provided information, the ALPHALOK™ Plating System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used for "bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist." This describes a surgical procedure for treating bone issues, not a diagnostic test performed on biological samples.
- Device Description: The device consists of "bone plates and screws" and associated surgical instruments. These are physical implants and tools used in surgery, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The ALPHALOK™ Plating System is a surgical implant used to fix bone fractures.
N/A
Intended Use / Indications for Use
ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx Mini Plates, is a multi-indication reconstruction solution providing polyaxial locking technology and low profile design.
All implant components are manufactured from titanium (Ti-6Al-4V, ASTM F136).
Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones or small bone fragments of the hand and wrist.
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)
The following performance data were provided in support of the substantial equivalence determination:
- . Torsional properties testing per ASTM F543-17
- . Axial pullout testing per ASTM F543-17
- Driving torque testing per ASTM F543-17
- Static four point bend testing per ASTM F382-17
In addition, cleaning and sterilization validations, performed in accordance with ANSI/AAMI/ISO 17665-1, from the applicant's own predicate device were leveraged.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
May 2, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" encircling it. To the right, there is a blue rectangle with the letters "FDA" in white, followed by the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vilex LLC % Roshana Ahmed Sr. Regulatory Affairs Specialist Telos Partners LLC 571 Christina Lake Drive Lakeland, Florida 33813
Re: K212348
Trade/Device Name: ALPHALOK™ 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 31, 2022 Received: March 31, 2022
Dear Roshana Ahmed:
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
1
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) 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 (QS) 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 medical devices and radiation-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,
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
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Indications for Use
510(k) Number (if known) K212348
Device Name
ALPHALOKTM Plating System
Indications for Use (Describe)
ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.
| 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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510(k) Summary
I. Submitter
Vilex LLC 111 Moffitt Street McMinnville, TN 37110
Contact Person: Louis Monaco, Director of Operations & Engineering Phone: (435)-659-1880 Date Prepared: May 2, 2022
II. Device
| Device Proprietary Name: | ALPHALOK TM Plating System |
|---|---|
| Common or Usual Name: | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories | |
| Smooth or threaded metallic bone fixation fastener | |
| Regulation Number: | 21 CFR 888.3030 (primary) |
| 21 CFR 888.3040 | |
| Product Code: | HRS |
| HWC | |
| Device Classification | II |
Predicate Device III.
Substantial equivalence is claimed to the following devices:
- Primary Predicate: .
- 0 Vilex Bone Plate Systems, K041287, Vilex, Inc.
- Additional Predicates ●
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IV. Device Description
The ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx Mini Plates, is a multi-indication reconstruction solution providing polyaxial locking technology and low profile design.
All implant components are manufactured from titanium (Ti-6Al-4V, ASTM F136).
Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.
Indications for Use V.
ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.
Comparison of Technological Characteristics VI.
The subject and predicate devices have similar intended uses and share identical core characteristics.
The systems are intended to be used in the hand and other small bones. Both systems include locking and non-locking screws with similar implant designs made from titanium alloy material, and instruments.
The technological differences between the subject device and predicate devices do not raise different questions of safety or effectiveness and substantial equivalence is demonstrated through the testing described below.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
- . Torsional properties testing per ASTM F543-17
- . Axial pullout testing per ASTM F543-17
- Driving torque testing per ASTM F543-17 ●
- Static four point bend testing per ASTM F382-17
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In addition, cleaning and sterilization validations, performed in accordance with ANSI/AAMI/ISO 17665-1, from the applicant's own predicate device were leveraged.
VIII. Conclusion
The information provided above supports that the ALPHALOK™ Plating System is as safe and effective as the predicate device. Although minor differences in design exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the ALPHALOK™ Plating System is substantially equivalent to the predicate devices.
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