(97 days)
Not Found
Not Found
No
The description focuses on the mechanical design and function of a bone screw system, with no mention of AI or ML.
Yes
The device is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation, which are all therapeutic interventions for medical conditions.
No
Explanation: The device is described as titanium bone screws for internal fixation, indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation. These are therapeutic and structural functions, not diagnostic ones.
No
The device description explicitly states it consists of "a set of titanium bone screws for internal fixation" and describes the physical mechanism of the screw and drill shank. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the SBi TwistoFIX is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- SBi TwistoFIX Function: The SBi TwistoFIX is a system of bone screws used for internal fixation during surgical procedures. It is implanted directly into the body to repair and stabilize bones.
- Lack of Specimen Analysis: The description of the SBi TwistoFIX does not mention any analysis of biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the SBi TwistoFIX falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Product codes
HWC
Device Description
The SBi TwistoFIX System consists of a set of titanium bone screws for internal fixation. The screws are machined on the end of a drill shank which inserts into a driver. After insertion of the screw into the bone, the drill shank twists off and breaks cleanly from the screw head. The devices are supplied non-sterile and are available in various sizes diameters and lengths.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
510(k) Summary
SEP 1 0 2007
| Manufacturer: | Small Bone Innovations International, SA
Z.A. Les Bruyeres
Peronnas France 01960 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations
1380 South Pennsylvania Avenue
Morrisville, PA 19067 |
| Proprietary Name: | SBi TwistoFIX |
| Classification name: | Class II, 888.3040 - Smooth or threaded metallic bone
fixation fastener |
| Common/Usual Name: | Screw, Fixation, Bone |
| Product Code: | HWC |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBi
TwistoFIX to be substantially equivalent to other legally
marketed devices. |
| Device Description: | The SBi TwistoFIX System consists of a set of titanium
bone screws for internal fixation. The screws are
machined on the end of a drill shank which inserts into a
driver. After insertion of the screw into the bone, the drill
shank twists off and breaks cleanly from the screw head.
The devices are supplied non-sterile and are available in
various sizes diameters and lengths. |
| Intended Use: | The SBi TwistoFIX is indicated for bone reconstruction,
osteotomy, fracture repair, and fracture fixation of bones
appropriate for the size of the device. |
| Material: | The implants are made from Ti-6Al-4V per ISO 5832-3 |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The image is in black and white.
SEP 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) % Small Bone Innovations International, SA Mr. Robert Hoehn Regulatory Associate 1380 S. Pennsylvania Avenue Morrisville, PA 19067
Re: K071541
Trade/Device Name: SBI TwistoFIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 5, 2007 Received: September 7, 2007
Dear Mr. Hoehn:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
2
Page 2 - Mr. Robert Hoehn
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jaubere Bueher
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number:
Device Name: SBi TwistoFIX
Indications For Use:
The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Barbara Buchro
Division of General, Restorative. and Neurological Devices
510(k) Number K071541