(278 days)
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.
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.
This K212348 FDA 510(k) summary provides information for the ALPHALOK™ Plating System, a bone fixation device. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document details performance data provided in support of substantial equivalence. The acceptance criteria are implicitly met by demonstrating performance equivalent to the predicate devices through standardized testing. The "reported device performance" is that the device passed these tests, indicating it performs comparably to the predicate.
| Acceptance Criteria (Implied by ASTM Standards) | Reported Device Performance (as stated in document) |
|---|---|
| Material Properties: | |
| - Biocompatibility (Titanium (Ti-6Al-4V, ASTM F136)) | - Material used: Titanium (Ti-6Al-4V, ASTM F136) |
| Mechanical Properties (Screws): | |
| - Torsional properties (per ASTM F543-17) | - Torsional properties testing per ASTM F543-17 was performed. (Implicitly passed, demonstrating equivalence) |
| - Axial pullout (per ASTM F543-17) | - Axial pullout testing per ASTM F543-17 was performed. (Implicitly passed, demonstrating equivalence) |
| - Driving torque (per ASTM F543-17) | - Driving torque testing per ASTM F543-17 was performed. (Implicitly passed, demonstrating equivalence) |
| Mechanical Properties (Plates): | |
| - Static four-point bend (per ASTM F382-17) | - Static four-point bend testing per ASTM F382-17 was performed. (Implicitly passed, demonstrating equivalence) |
| Cleaning and Sterilization: | |
| - Cleaning validation (per ANSI/AAMI/ISO 17665-1) | - Cleaning validations performed (leveraged from predicate device). (Implicitly passed, demonstrating equivalence) |
| - Sterilization validation (per ANSI/AAMI/ISO 17665-1) | - Sterilization validations performed (leveraged from predicate device). (Implicitly passed, demonstrating equivalence) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each mechanical test. The tests are described as being performed "per ASTM F543-17" and "per ASTM F382-17," which implies that the sample sizes would adhere to the recommendations or requirements within those specific ASTM standards.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate the performance of the ALPHALOK™ Plating System.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This section is not applicable as the studies are mechanical performance tests of a physical device (bone plates and screws), not a diagnostic or AI-driven system requiring expert ground truth for interpretation. The "ground truth" here is the physical performance data measured according to established engineering standards.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reason as point 3. Mechanical performance tests typically do not involve human adjudication; the results are quantifiable measurements against established engineering benchmarks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or imaging devices that rely on human interpretation, often assisted by AI. The ALPHALOK™ Plating System is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm performance study was not done. This device is a physical surgical implant, not an algorithm or software.
7. The Type of Ground Truth Used:
The "ground truth" for the performance studies of this device is based on standardized engineering specifications and measurements defined by the ASTM (American Society for Testing and Materials) and ANSI/AAMI/ISO standards. This includes:
- Mechanical properties: Measured values for torsional strength, axial pullout force, driving torque, and static four-point bend strength.
- Material properties: Chemical composition and physical properties of the titanium alloy, specified by ASTM F136.
- Cleaning and sterilization efficacy: Measured outcomes of cleaning and sterilization processes against predefined acceptance criteria for microbial reduction and residue levels.
8. The Sample Size for the Training Set:
This question is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
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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
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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, BoneScrew, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances andaccessoriesSmooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3030 (primary)21 CFR 888.3040 |
| Product Code: | HRSHWC |
| 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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§ 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.