(77 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence of bone screws, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is an implantable system for fixation of bone fractures and osteotomies, rather than providing or supporting a therapeutic function.
No
Explanation: The device is an implantable bone screw system used for fixation of bone fractures and osteotomies. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the device includes "an implantable device system" consisting of "cannulated and solid screws" fabricated from "titanium or stainless steel." This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures, malunions, non-unions, osteotomies, and arthrodesis. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is an implantable system of bone screws made of titanium or stainless steel. These are physical implants used to stabilize bone.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a surgical implant used for orthopedic procedures, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Bone Screw Line Addition is intended to be used for the following indications:
- · Bone fractures
- o Jones fractures
- o Acute fractures
- o Avulsion fractures
- o Repetitive stress fractures
- o Malleolar fractures
- o Talus fractures
- o Greater tuberosity fractures
· Fixation of malunions and non-unions
- · Osteotomies
- · Arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The Vilex Bone Screw Line Addition includes an implantable device system intended for fixation of bone fractures and osteotomies of the upper and lower extremities. The Bone Screw Line Addition (BSLA) system consists of cannulated and solid screws. The implants are offered fully or partially threaded and in 4.5, 5.5, and 6.0 mm thread diameters. The BSLA implants are fabricated from either titanium or stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities
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)
Engineering analyses demonstrated that the BSLA does not introduce an added risk when compared to the cleared predicate devices. Analysis was used to demonstrate substantially equivalent mechanical strength (i.e., torsional strength, shear strength, bending strength, and pull out strength). Analyses and evaluation concluded that the subject BSLA is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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/0 description: The image shows the date July 29, 2019. The text is written in a clear, sans-serif font. The date is likely extracted from a document or image, indicating a specific date of relevance.
Vilex in Tennessee, Inc Victor Lavi Executive Vice President 111 Moffitt Street McMinnville, Tennessee 37110
Re: K191289
Trade/Device Name: Bone Screw Line Addition Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: May 8, 2019 Received: May 13, 2019
Dear Victor Lavi:
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
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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,
Shumaya Ali, MPH 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) K191289
Device Name
Bone Screw Line Addition
Indications for Use (Describe)
The Bone Screw Line Addition is intended to be used for the following indications:
- · Bone fractures
- o Jones fractures
- o Acute fractures
- o Avulsion fractures
- o Repetitive stress fractures
- o Malleolar fractures
- o Talus fractures
- o Greater tuberosity fractures
· Fixation of malunions and non-unions
- · Osteotomies
- · Arthrodesis
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Bone Screw Line Addition
l. Submitter:
Vilex in Tennessee, Inc. 111 Moffitt Street McMinnville, TN 37110
Contact Person: Victor Lavi Executive VP Email: info@vilex.com Phone: 931-474-7550
Date of Summary: July 2, 2019
II: Device
| Proprietary Name: | Bone Screw Line Addition (BSLA) |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR 888.3040 Smooth or Threaded Metallic Bone |
| Fixation Fastener | |
| Device Product Codes: | HWC, HTN |
| Panel: | Orthopedic |
III. Predicate Devices
| Device | Manufacturer | 510(k) No. | Clearance Date |
|---|---|---|---|
| Primary predicate | |||
| Vilex/Orthex/Duval Cannulated Bone | |||
| Screw | Vilex, Inc. | K991197 | 04/26/1999 |
| Predicates | |||
| Charlotte Carolina Jones Fracture | |||
| System Screw | Wright Medical | ||
| Technology, Inc. | K140952 | 05/15/2014 | |
| Asnis JFX System | Stryker Trauma | ||
| AG | K153154 | 12/28/2015 |
IV. Device Description
The Vilex Bone Screw Line Addition includes an implantable device system intended for fixation of bone fractures and osteotomies of the upper and lower extremities. The Bone
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510(k) Summary
Bone Screw Line Addition
Screw Line Addition (BSLA) system consists of cannulated and solid screws. The implants are offered fully or partially threaded and in 4.5, 5.5, and 6.0 mm thread diameters. The BSLA implants are fabricated from either titanium or stainless steel.
V. Intended Use
The Bone Screw Line Addition is intended to be used for the following indications:
- . Bone fractures
- o Jones fractures
- o Acute fractures
- o Avulsion fractures
- Repetitive stress fractures o
- Malleolar fractures o
- o Talus fractures
- o Greater tuberosity fractures
- Fixation of malunions and non-unions ●
- Osteotomies
- Arthrodesis
VI. Comparison of Technological Characteristics with the Predicate Devices
The BSLA is technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety. The BSLA is manufactured from the same materials as the listed predicate devices. Screws have similar lengths and similar diameters. Washers have similar inner and outer diameters. The Vilex BSLA devices differ slightly in thread form and screw head geometry from the predicate devices. Analyses confirmed that the BSLA is substantially equivalent when compared to the predicate devices. The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness.
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Bone Screw Line Addition
VII. Performance Data
Engineering analyses demonstrated that the BSLA does not introduce an added risk when compared to the cleared predicate devices. Analysis was used to demonstrate substantially equivalent mechanical strength (i.e., torsional strength, shear strength, bending strength, and pull out strength).
Analyses and evaluation concluded that the subject BSLA is substantially equivalent to the predicate devices.
VIII. Conclusions
A review of the device indications, material composition, bone screw and washer design, and technological characteristics confirmed that the BSLA are substantially equivalent to the predicate devices. While the BSLA are not identical to the predicate devices, comparisons of the subject and predicate devices confirmed that any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices. Therefore, it is concluded that the Bone Screw Line Addition is substantially equivalent to the predicate devices.