(684 days)
Not Found
No
The summary describes a mechanical bone screw and its performance characteristics, with no mention of AI or ML.
Yes
The device is used for fracture repair, fixation, reconstruction, arthrodesis, and joint fusion, which are all therapeutic procedures.
No
The J-Screw is intended for surgical procedures like osteotomy and fracture fixation, not for identifying the presence, nature, or absence of a disease or condition.
No
The device description clearly describes a physical bone screw, which is a hardware component, not software.
Based on the provided information, 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 and Intended Use: The J-Screw is described as a bone screw used for surgical procedures like osteotomy, fracture repair, and fusion of small bones. It is a physical implant used directly on the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing bodily fluids, or providing diagnostic information based on laboratory analysis.
The J-Screw is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.
Product codes
HWC
Device Description
The J-Screw is a two part bone screw for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities. The unique design of the device allows it to fixate or fuse small bones with infinitely adjustable fusing compression, in a fixed yet flexed position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the 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
Performance data gathered for insertion and removal torque, torsional yield strength, maximum torque, breaking angle, as well as axial pullout strength was gathered as outlined by ASTM F543-13 with qualified processes and material. Performance data gathered for static cantilever bending force submitted with test outline.
Key Metrics
Not Found
Predicate Device(s)
K990804, K110445, K122031, K052736
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2014
Competitive Engineering, Incorporated David M. Davis Engineering Manager 3371 East Hemisphere Loop Tucson, Arizona 85706
Re: K130019 Trade/Device Name: J-Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 24, 2014 Received: September 30, 2014
Dear Mr. Davis:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. David M. Davis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5. Indications for Use Statement
K130019 page 1 of 1
J-Screw Intended Use:
The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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6. 510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the J-Screw is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.
| Applicant: | Competitive Engineering, Inc. |
|---|---|
| Address: | 3371 E. Hemisphere Loop |
| Tucson, AZ 85706 | |
| Contact Person: | David M. Davis |
| Telephone: | 520-746-0270 X-106 |
| Fax: | 520-746-0481 |
| Preparation Date: | November 13, 2014 |
| Device Trade Name: | J-Screw |
| Common Name: | Compression screw |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HWC |
| Regulatory Class; | |
| Legally Marketed | |
| Predicates: | StayFuse (K990804) |
| FlexFusion Fixation implant (K110445) | |
| Nextra Ti Hammertoe Correction System (K122031) | |
| Arthrex K-Wire (K052736) | |
| Device Description: | The J-Screw is a two part bone screw for use in |
| osteotomy, reconstruction, arthrodesis, joint fusion, | |
| fracture repair, and fracture fixation of small bones of the | |
| upper and lower extremities. The unique design of the | |
| device allows it to fixate or fuse small bones with | |
| infinitely adjustable fusing compression, in a fixed yet | |
| flexed position. | |
| Intended Use: | The J-Screw is indicated for use in osteotomy, |
| reconstruction, arthrodesis, joint fusion, fracture repair, | |
| and fracture fixation of small bones of the upper and | |
| lower extremities. | |
| Performance Data: | Performance data gathered for insertion and removal |
| torque, torsional yield strength, maximum torque, | |
| breaking angle, as well as axial pullout strength was | |
| gathered as outlined by ASTM F543-13 with qualified | |
| processes and material. Performance data gathered for | |
| static cantilever bending force submitted with test | |
| outline. | |
| Conclusion: | The J-Screw possesses the same technologic |
| characteristics of the predicate devices. These | |
| characteristics include the intended use, basic threaded | |
| design, material, size as specified by medical | |
| professionals, and fundamental technology. The J-Screw | |
| is substantially equivalent to the predicate bone fixation | |
| devices. |
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510(k) Summary of Safety and Effectiveness for the J-Screw continued: