(49 days)
Not Found
Not Found
No
The summary describes a mechanical bone screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used in the treatment of fractures, non-unions, pseudoarthrosis, and degenerative changes, aiming for functionally stable osteosynthesis in small bones. This indicates a therapeutic purpose.
No
The device description indicates it is a surgical implant (bone screws) for treating fractures and other bone conditions, not for diagnosing them.
No
The device description clearly states it consists of "Cannulated and Non-Cannulated bone screws," 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the SBi AutoFIX Twin Pitch Cannulated Compression Screw System consists of implants (bone screws) intended for the treatment of fractures, non-unions, etc., in small bones. These are physical devices inserted into the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or providing diagnostic information based on such tests.
Therefore, based on the provided information, the SBi AutoFIX Twin Pitch Cannulated Compression Screw System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SBI AutoFix implants are primarily intended for permanent implantation in these areas: scaphoid fractures,carpal fractures and fusions, metacarpal fractures and osteotomies, distal radius fractures (articular fragments), ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, periarticular phalangeal fractures, metatarsal fractures and osteotomies, tarsal fusions, tarsal fractures, malleolar fractures, patellar fractures, osteochondral fractures, talo- navicular fusions, tibeo-talar fusions, cuboid fusions.
The SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The SBI AutoFix™ System consists of a series of Cannulated and Non-Cannulated bone screws varying in length and diameter. The SBI AutoFix™ System is intended for use on selected fractures in the body as medically indicated and bone mass compatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scaphoid, carpal, metacarpal, distal radius, ulnar styloid, radial head, capitellum, humeral head, glenoid, intercarpal distal, intercarpal proximal, periarticular phalangeal, metatarsal, tarsal, malleolar, patellar, talo-navicular, tibeo-talar, cuboid, small bones.
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): 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.
Not Found
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.
0
K052576 p4/1
NOV - 7 2005
:
510(k) Summary
| Manufacturer: | Small Bone Innovations International S.A.
ZA Les Bruyeres
01960 Peronnas
France |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Donald W. Guthner, Vice President
Musculoskeletal Clinical Regulatory Advisers
505 Park Avenue, 14th Floor
New York, NY 10022
dguthner@mcrallc.com
212-586-0250 - Office
212-750-2112 - Fax |
| Proprietary Name: | SBI AutoFix™ System |
| Classification name: | Class II, 888.3040 - Screw, Fixation, Bone, Non-Spinal |
| Common/Usual Name: | Internal Fixation Device |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI
AutoFix™ System to be substantially equivalent to other
legally marketed devices. |
| Device Description: | The SBI AutoFix™ System consists of a series of
Cannulated and Non-Cannulated bone screws varying in
length and diameter. The SBI AutoFix™ System is
intended for use on selected fractures in the body as
medically indicated and bone mass compatible. |
| Intended Use: | The SBI AutoFix™ implants are primarily intended for
permanent implantation in these areas: scaphoid
fractures,carpal fractures and fusions, metacarpal fractures
and osteotomies, distal radius fractures (articular
fragments), ulnar styloid fractures, radial head fractures,
capitellum fractures, humeral head fractures, glenoid
fractures, intercarpal distal and proximal fusions,
periarticular phalangeal fractures, metatarsal fractures and
osteotomies, tarsal fusions, tarsal fractures, malleolar
fractures, patellar fractures, osteochondral fractures, talo-
navicular fusions, tibeo-talar fusions, cuboid fusions. |
| Material: | Available in stainless steel and titanium |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized representation of an eagle, which is a common symbol of the United States. The eagle is depicted with its wings spread, and its body is formed by three curved lines.
Public Health Service
NOV - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations, LLC c/o Donald Guthner, Vice President Musculoskeletal Clinical Regulatory Advisers, LLC 505 Park Avenue, 14th Floor New York, New York 10022
Re: K052576
Trade/Device Name: SBI AutoFix" System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 15, 2005 Received: September 19, 2005
Dear Mr. Guthner:
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 - Donald Guthner, Vice President
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
So Mark N. Melkerson Acting 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 AutoFix™ System
Indications For Use:
The SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.
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
Signature
sion Sign-Off) Division of General, Restorative, and Neurological Devices
16052576