(65 days)
Not Found
Not Found
No
The summary describes a mechanical fixation device (staples) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an internal fixation system for fractures, osteotomies, and arthrodesis, which are therapeutic interventions.
No
The device, SBi StaFIX, is indicated for the fixation of fractures, osteotomies, and arthrodesis, and fixation of soft tissue to bone. These are therapeutic/surgical functions, not diagnostic ones.
No
The device description explicitly states it consists of "a set of stainless steel staples for internal fixation," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "Fixation of fractures, osteotomies, and arthrodesis (fusion) in long and small bones" and "Fixation of soft tissue to bone." This describes a surgical implant used within the body for structural support and repair.
- Device Description: The description confirms it's a "set of stainless steel staples for internal fixation." This further reinforces its use as an implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing blood, urine, tissue samples, etc.
Therefore, the SBi StaFIX is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SBi StaFIX is indicated for:
- Fixation of fractures, osteotomies, and arthrodesis (fusion) in long and small bones.
- Fixation of soft tissue to bone.
Product codes
JDR
Device Description
The SBi StaFIX System consists of a set of stainless steel staples for internal fixation. The devices are supplied non-sterile and are available in several configurations and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Long and 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Ko 71479 page 191
510(k) Summary
AUG - 2 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 StaFIX Class II, 888.3030 - Single/multiple component metallic Classification name: bone fixation appliances and accessories Common/Usual Name: Staple, Fixation, Bone Product Code: JDR Substantial Equivalence: Documentation is provided which demonstrated the SBi StaFIX to be substantially equivalent to other legally marketed devices. Device Description: The SBi StaFIX System consists of a set of stainless steel staples for internal fixation. The devices are supplied non-sterile and are available in several configurations and sizes. Intended Use: The SBi StaFIX is indicated for: . Fixation of fractures, osteotomies, and arthrodesis (fusion) in long and small bones. . Fixation of soft tissue to bone Material: The implants are made from 316L Stainless Steel in accordance with ISO 5832-1.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 2007
Small Bone Innovations, Inc. % Mr. James O'Connor VP. OA/OC & Regulatory Affairs 1380 South Pennsylvania Avenue Morrisville, PA 19067
Re: K071479 Trade/Device Name: SBi StaFix Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: May 25, 2007 Received: May 29, 2007
Dear Mr. O'Connor:
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.
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Page 2 -- Mr. James O'Connor
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" (21 CFR 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,
Mark A. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K.071479
Indications for Use
510(k) Number:
Device Name: SBi StaFIX
Indications For Use:
The SBi StaFIX is indicated for:
- Fixation of fractures, osteotomies, and arthrodesis (fusion) in long and small . bones.
- Fixation of soft tissue to bone .
Prescription Use √ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
unter Use No
(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
Mark A. Milliken
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K071479
510(k) Number