(164 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of bone screws, with no mention of AI or ML.
Yes
The device is described as a "Compression Screw System" used for "fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones," which indicates its use in treating and correcting medical conditions.
No
This device is a surgical screw system used for fracture repair and fixation, osteotomy, joint fusion, and reconstruction. It is an implantable device used to treat conditions, not to diagnose them.
No
The device description clearly details physical components such as screws, washers, and instruments made of titanium, intended for surgical implantation and use. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Accelerate Compression Screw System is a system of screws and instruments used for surgical procedures like fracture repair, osteotomy, and fusion of bones. It is implanted directly into the body.
- Intended Use: The intended use is for surgical fixation and repair of bones, not for testing biological samples.
The description clearly indicates a surgical implant and associated instruments, which fall under the category of medical devices used in vivo (within the body), not in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
The Accelerate Compression Screw System is indicated for use in adult and skeletally mature pediatric patients (aged 12-21 years), for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The Trax Accelerate Compression Screw System is intended to be used to treat fracture and reconstruction of the small bones of the extremities (hands and feet). The screws are manufactured from 6AL-4V titanium and are anodized in various colors for easy size recognition. Washers will be provided for some screw sizes as appropriate. The fixation screws come in three (3) different configurations, headed, headless and break away. The headed and headless screws are cannulated. The breakaway screws are solid. They vary in diameter and length to allow the surgeon to select the appropriate device for the patient's anatomy. All devices are intended to be provided in an autoclavable instrument tray that includes a set of Class I instruments. The set will be provided non-sterile to the end user.
The surgical instruments are intended to prepare the site and fixate the screws. The screws and instruments shall be designed to be maintained in an autoclavable tray. Replacement implants and instruments will be available separately as required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device.
Indicated Patient Age Range
adult and skeletally mature pediatric patients (aged 12-21 years)
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)
Performance of the Accelerate Compression Screw System was evaluated in accordance with ASTM F543-17 and the FDA quidance Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway. Static torsion (torque to failure), Insertion / Removal torque and Axial pullout testing was performed to demonstrate substantial equivalence to the predicate devices.
Biocompatibility of patient contacting materials was demonstrated by using materials that meet applicable standards and / or used in 510(k) cleared devices (K172383).
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.
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.
0
September 15, 2023
Image /page/0/Picture/1 description: The image contains 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Trax Surgical Stephen Deane Senior Vice President 75 Mill Street Stoughton, Massachusetts 02072
Re: K230946
Trade/Device Name: Accelerate Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: August 9, 2023 Received: August 11, 2023
Dear Stephen Deane:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 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 -S
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230946
Device Name Accelerate Compression Screw System
Indications for Use (Describe)
The Accelerate Compression Screw System is indust and skeletally mature pediatic patients (aged 12-21 years), for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
| 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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3
510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Accelerate Compression Screw System.
| Submitted by: | Trax Surgical, Inc.
75 Mill Street
Stoughton, MA 02072 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | March 13, 2023 |
| Contact Person: | Stephen Deane
781.828.4400
sdeane@primomedicalgroup.com |
| Proprietary Name: | Accelerate Compression Screw System |
| Common Name: | Screw, Fixation, Bone
Washer, Bolt, Nut |
| Classification Name and Reference: | 21 CFR 888.3040 (Primary), Smooth or threaded metallic
bone fixation fastener (Primary), Class II
21 CFR 888.3030, Single / multiple component metallic bone
fixation appliances and accessories, Class II |
| Device Product Code, Device Panel: | HWC (Primary), HTN, Orthopedic |
| Primary Predicate Device: | Captivate Compression Screws (K222409) |
| Additional Predicate Devices: | GEO Bone Screw System (K202817)
Treace Medical Concepts Snap-off Screw System (K183363) |
| Reference Device: | Arthrosurface Bone Screws (K172383) |
Device Description 5.1
The Trax Accelerate Compression Screw System is intended to be used to treat fracture and reconstruction of the small bones of the extremities (hands and feet). The screws are manufactured from 6AL-4V titanium and are anodized in various colors for easy size recognition. Washers will be provided for some screw sizes as appropriate. The fixation screws come in three (3) different configurations, headed, headless and break away. The headed and headless screws are cannulated. The breakaway screws are solid. They vary in diameter and length to allow the surgeon to select the appropriate device for the patient's anatomy. All devices are intended to be provided in an autoclavable instrument tray that includes a set of Class I instruments. The set will be provided non-sterile to the end user.
4
The surgical instruments are intended to prepare the site and fixate the screws. The screws and instruments shall be designed to be maintained in an autoclavable tray. Replacement implants and instruments will be available separately as required.
5.2 Indication for Use
The Accelerate Compression Screw System is indicated for use in adult and skeletally mature pediatric patients (aged 12-21 years), for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
5.3 Performance Data
Performance of the Accelerate Compression Screw System was evaluated in accordance with ASTM F543-17 and the FDA quidance Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway. Static torsion (torque to failure), Insertion / Removal torque and Axial pullout testing was performed to demonstrate substantial equivalence to the predicate devices.
Biocompatibility of patient contacting materials was demonstrated by using materials that meet applicable standards and / or used in 510(k) cleared devices (K172383).
5.4 Technological Characteristics
The subject Accelerate Compression implants (screws and washers) have similar technological characteristics as the predicate devices including indications for use, materials and coatings, function and range of sizes.
Trax Surgical believes that the Accelerate Compression Screw System is as safe and effective and performs in a substantially equivalent manner to the predicate devices.
5.5 Conclusion
The subject Trax Surgical Accelerate Compression Screw System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance and intended use. The information provided supports substantial equivalence to the predicate device.