(132 days)
Not Found
No
The device description and intended use clearly describe a system of physical screws, washers, guide wires, and instruments for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for the fixation of bone fractures and arthrodesis, which are therapeutic interventions aimed at treating medical conditions.
No
The device is described as a system of screws and washers for fixation of bones, which is a therapeutic rather than a diagnostic function. Its 'Intended Use' includes fixing various fractures and arthrodesis, not diagnosing conditions.
No
The device description explicitly states it consists of screws, washers, guide wires, and instruments, which are all physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The SBi Foot and Ankle Cannulated Screw System is a surgical implant used for the fixation of bones. It is a physical device implanted into the body.
- Intended Use: The intended use describes the surgical procedures and anatomical locations where the screws are used for fixation. This is a therapeutic use, not a diagnostic one.
The information provided clearly describes a surgical implant used for treatment, not a device used for testing samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The SBi Foot and Ankle Cannulated Screw System is indicated for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The SBi Foot and Ankle Cannulated Screw System consists of screws and washers that provide fixation of small and long bones. The devices are supplied non-sterile and are available in various sizes and configurations. There are several lengths and diameters of the cannulated screws washers appropriate to the screw diameter. There are fully threaded and partially threaded (16mm and 32mm of thread) configurations. The system also includes guide wires and instruments for use in implanting the screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and long bones, such as femoral neck, tibial plateau, ankle, pediatric femur, intercondylar femur, sacroiliac joint, subtalar. Not intended for spinal use.
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.
K962011, K021932, K052483, K983006, K000080
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
092754
510(k) Premarket Notification Summary of Safety and Effectiveness
Submission Information
| Manufacturer: | Small Bone Innovations, Inc.
1380 South Pennsylvania Avenue
Morrisville, PA 19067
Ph: 215-428-1791 Fax: 215-428-1795 |
|---------------|-------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations, Inc.
John Minier
1380 South Pennsylvania Avenue
Morrisville, PA 19067 |
Proprietary Name: SBi Foot and Ankle Cannulated Screw System
Classification name: Class II, 21 CFR 888.3040 - Screw, Fixation, Bone
Product Code: HWC
Common/Usual Name and Reference Number: Primary: Smooth or threaded metallic bone fixation fastener, 21 CFR 888.3040
Substantial Equivalence: Documentation is provided which demonstrated the SBi Large Cannulated Screw System to be substantially equivalent to other legally marketed devices.
Device Description: The SBi Foot and Ankle Cannulated Screw System consists of screws and washers that provide fixation of small and long bones. The devices are supplied non-sterile and are available in various sizes and configurations. There are several lengths and diameters of the cannulated screws washers appropriate to the screw diameter. There are fully threaded and partially threaded (16mm and 32mm of thread) configurations. The system also includes guide wires and instruments for use in implanting the screws.
Intended Use: The SBi Foot and Ankle Cannulated Screws and Washers are intended for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.
The implants are intended for single use only.
Materials: The implants are made from implant grade 316LS stainless steel (ASTM F138) in a set with several thread configurations in a range of lengths and will include the appropriate size washers of the same material. Another implant set is made from implant grade Titanium Allov
$$\nsearrow \nearrow \nsearrow \subset$$
1
(ASTM F136) which will consist of similar thread configurations and range of lengths and will include the appropriate size washers of the same material.
Predicate Devices: The subject devices are equivalent to Synthes 6.5mm and 7.0/7.3mm Cannulated Screws (K962011, K021932, K052483) and Howmedica Osteonics (Stryker) Asnis III 5.0mm, 6.5mm, and 8.0mm Cannulated Screws (K983006, K000080).
- p. 2 of 2
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Small Bone Innovations, Inc. % Mr. John Minier Regulatory Affairs Director 1380 South Pennsylvania Avenue Morrisville, Pennsylvania 19067
JAN 1 9 2010
Re: K092754
Trade/Device Name: SBi Foot and Ankle Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fasteners Regulatory Class: II Product Code: HWC Dated: December 23, 2009 Received: December 29, 2009
Dear Mr. Minier:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2- Mr. John Minier
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Joulan Mucho
for
Mark N. Melk Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4 Statement of Indications for Use
510(k) Number:
Image /page/4/Picture/2 description: The image shows a handwritten alphanumeric string. The string appears to be "K092754". The characters are written in a simple, slightly irregular style, typical of handwriting.
Device Name: SBi Foot and Ankle Cannulated Screw System
Indications For Use:
The SBi Foot and Ankle Cannulated Screw System is indicated for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondy|ar femur fractures; sacroillac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.
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
Ouster for MXM
(Division Sign-Onl. Orthopedic, Division of Sure
and Restorative Devices
510(k) Number K092754