(129 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device is a mechanical screw system.
Yes
The device is indicated for fixation of fractures, arthrodesis, and osteotomies, which are therapeutic interventions.
No
The device is described as a "BioDrive® Cannulated Screw System" used for fixation of fractures, arthrodesis, and osteotomies. Its function is to provide physical support and stabilization to bones, not to diagnose a condition.
No
The device description explicitly states it consists of physical components made of Titanium alloy, including screws, washers, guide wires, and instruments.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the BioDrive® Cannulated Screw System is for the fixation of bones and joints. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is described as cannulated screws, washers, guide wires, and instruments made of titanium alloy. These are physical implants and surgical tools, not reagents, kits, or instruments used to examine specimens in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro to examine specimens from the human body to provide information for diagnostic purposes. The BioDrive® Cannulated Screw System is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
The BioDrive® Cannulated Screw System is indicated for the following:
- Fixation of fractures in long bones
- Fixation of small bones, including those in the foot, patella, ankle, wrist & elbow
- Arthrodesis of the foot, wrist and elbow
- Small and long bone osteotomies
- Fixation of pelvis and the illiosacral joint
Product codes
HWC
Device Description
The Biodrive® Cannulated Screw System consists of cannulated screws of various diameters and lengths with four threaded configurations. The system includes 3 different size washers, the use of which are optional, as well as guide wire and complete instruments. They are made from made Titanium alloy (Ti-6AL-4V) in conformance with ASTM F136 standard. The Titanium screws are also available acid etched (Osseotite™).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones, foot, patella, ankle, wrist, elbow, pelvis, illiosacral joint
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
Non-Clinical Testing: An engineering rationale has been prepared to demonstrate substantial equivalence to similar commercially available products. This engineering rationale can be found in Section 18.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K024086, K070955, K012945, K021932, K040765, K962011, K963172, K962823, K051296
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
This summary of 510(k) safety and effectiveness information is being submitted in
accordance with the requirements of 21 CED & 007 00 accordance with the requirements of 21 CFFR § 807 93
| Submitter: | Biomet Trauma
100 Interpace Parkway
Parsippany, NJ 07054 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 2242816 |
| Contact: | Debra L. Bing
Director Regulatory Affairs
Biomet Trauma
100 Interpace Parkway
Parsippany, NJ 070654
Tel.: 973-299-9300
Fax: 973-257-0232
E-mail: debra.bing@ebimed.com |
| Date Prepared:
Trade/Proprietary Name: | July, 18 2008
BioDrive® Cannulated Screw System |
| Common/Usual Name: | Bone Screw |
| Classification Name: | Screw, Fixation, Bone (888.3040) |
| Device Classification: | II |
| Predicate Device: | Propeller Head Small Cannulated Screw System
(K024086)
Acid Etched Lag Screws (K070955)
Synthes Cannulated Screws (K012945, K021932,
K040765, K962011, K963172, K962823)
DePuy SIJF Cannulated Screw System (K051296) |
| Non-Clinical Testing: | An engineering rationale has been prepared to
demonstrate substantial equivalence to similar
commercially available products. This engineering
rationale can be found in Section 18. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |
| Device Description: | The Biodrive® Cannulated Screw System consists of |
FEB -5 2009
1
cannulated screws of various diameters and lengths with four threaded configurations. The system includes 3 different size washers, the use of which are optional, as well as guide wire and complete instruments. They are made from made Titanium alloy (Ti-6AL-4V) in conformance with ASTM F136 standard. The Titanium screws are also available acid etched (Osseotite™).
Indications for Use:
- Fixation of fractures in long bones .
- Fixation of small bones, including those in the . foot, patella, ankle, wrist & elbow
- Arthrodesis of the foot, wrist and elbow ●
- Small and long bone osteotomies .
- Fixation of pelvis and the illiosacral joint .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is facing to the right.
Public Health Service
FEB - 5 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Trauma % Ms. Christina Lakin, M.S. Regulatory Consultant 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K082874
Trade/Device Name: BioDrive® Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 6, 2009 Received: January 7, 2009
Dear Ms. Lakin:
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.
3
Page 2 - Ms. Christina Lakin, M.S.
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 Biometrics' (OSB's) Division of Protmarket, 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 iter toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K082874
Device Name: BioDrive® Cannulated Screw System
Indications for Use: The BioDrive® Cannulated Screw System is indicated for the following:
- Fixation of fractures in long bones ●
- Fixation of small bones, including those in the foot, patella, ankle, wrist & elbow
- Arthrodesis of the foot, wrist and elbow
- Small and long bone osteotomies
- Fixation of pelvis and the illiosacral joint
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-O)
Division of Gener !. Restorative, and Neurological Devices
510(k) Number K081874