(90 days)
Not Found
No
The document describes a mechanical screw system and surgical instruments, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
Explanation: This device is an orthopedic screw system used for fixation, which is a supportive and stabilizing function rather than a direct therapeutic intervention. It helps in the healing process but doesn't actively treat a disease or condition itself.
No
The device is a screw system for fixing bones after surgery or injury, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes screws and surgical instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The In2Bones IBS-B MIS Beveled Screw System is a surgical implant (screws) and associated instruments used for fixing bones during surgery. It is used in vivo (within the body), not in vitro (in a lab setting).
- Intended Use: The intended use is for the fixation of bones, which is a surgical procedure, not a diagnostic test.
The provided information clearly describes a medical device used for surgical intervention, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies of long or short bones of the upper and lower limbs appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The In2Bones IBS-B MIS Beveled Screw System includes screws and surgical instruments intended for fixation of arthrodesis, osteotomies of the long or short bones of the upper and lower limbs. The screws will be offered in neutralization version (fully threaded) and compression version (partially threaded) in 3.3mm, 4.0mm and 6.5mm diameters. The screws are offered sterile single-use and are made from titanium alloy (ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long or short bones of the upper and lower limbs
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 analysis was utilized to compare the IBS-B MIS Beveled Screw System to the predicate devices to support substantial equivalence with regard to mechanical performance. The IBS-B MIS Beveled Screw System was validated per ISO 11137-2 for gamma sterilization.
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.
K131920, K162353, K170518, K180377
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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July 27, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, and on the right, there is the FDA logo. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
In2Bones USA, LLC Christine Scifert VP, Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38119
Re: K231236
Trade/Device Name: IBS-B MIS Beveled Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 26, 2023 Received: April 28, 2023
Dear Christine Scifert:
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
1
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,
Shumava A
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) K231236
Device Name IBS-B MIS Beveled Screw System
Indications for Use (Describe)
The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies of long or short bones of the upper and lower limbs appropriate for the size of the device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
IBS-B MIS Beveled Screw System July 25, 2023
| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|--------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | IBS-B MIS Beveled Screw System |
| Common Name: | Screw, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HWC |
The In2Bones IBS-B MIS Beveled Screw System includes screws and surgical Device Description: instruments intended for fixation of arthrodesis, osteotomies of the long or short bones of the upper and lower limbs. The screws will be offered in neutralization version (fully threaded) and compression version (partially threaded) in 3.3mm, 4.0mm and 6.5mm diameters. The screws are offered sterile single-use and are made from titanium alloy (ASTM F136).
Indications for Use: The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs appropriate for the size of the device.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
- . K131920 - In2Bones SAS Osteosynthesis Screws
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Additional Predicates
The subject IBS-B MIS Beveled Screw System screws are similar geometry to the previously cleared In2Bones SAS IBS Osteosynthesis Screws and is made of titanium alloy (ASTM F136). The IBS-B MIS Beveled Screw System has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.
Performance Testing: Engineering analysis was utilized to compare the IBS-B MIS Beveled Screw System to the predicate devices to support substantial equivalence with regard to mechanical performance. The IBS-B MIS Beveled Screw System was validated per ISO 11137-2 for gamma sterilization.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.