(57 days)
Not Found
No
The summary describes a mechanical screw system and its intended use for bone fixation. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making capabilities.
Yes
The device is described as a "Compression Screw System" used for "alignment and stabilization of small bone fractures" and other orthopedic procedures. This directly addresses medical conditions and aims to restore function, aligning with the definition of a therapeutic device.
No
The device is a surgical implant (screw system) used for fixation and stabilization of small bone fractures and other orthopedic conditions. It is not designed to diagnose diseases or conditions.
No
The device description explicitly states it is a "Variable Pitch Compression Screw System" and describes physical components made of Titanium Alloy, along with instrumentation. This indicates a hardware medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a "Variable Pitch Compression Screw System" used for "alignment and stabilization of small bone fractures." It's a physical implantable device used in surgical procedures.
- Intended Use: The intended use is for surgical fixation of bones and ligaments, not for testing biological samples.
The information provided describes a surgical implant and its intended use in orthopedic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Variable Pitch Compression Screw System is indicated for alignment and stabilization of small bone fractures. Specifically:
- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand fractures, non-unions, or mal-unions
- Ligament reconstruction
- Osteochondritis dissecans
- Arthrodesis of the foot, ankle, wrist, elbow and hand
- Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies.
These procedures may be indicated as part of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Product codes
HWC
Device Description
The Biomet Variable Pitch Compression Screw System offers headless, cannulated compression screws in three different diameters in various lengths. The screws are manufactured from Titanium Alloy (ASTM F136) and are either color anodized or passivated for ease of size identification. The system will also include instrumentation to aid the user in alignment and stabilization of fractures to the skeletal system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, wrist, elbow and hand
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)
Non-clinical performance testing included mechanical testing to ASTM F543 to determine substantial equivalence of the Biomet Variable Pitch Compression Screw System. Results indicate that the subject system is substantially equivalent to legally marketed devices. No clinical tests are provided for basis of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of what appears to be a family.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2016
Biomet Incorporated Ms. Julie Largent Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K160058
Trade/Device Name: Biomet Variable Pitch Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 11, 2016 Received: January 12, 2016
Dear Ms. Largent:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160058
Device Name
Variable Pitch Compression Screw System
Indications for Use (Describe)
The Variable Pitch Compression Screw System is indicated for alignment and stabilization of small bone fractures. Specifically:
· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand fractures, non-unions, or mal-unions
- Ligament reconstruction
- · Osteochondritis dissecans
- · Arthrodesis of the foot, ankle, wrist, elbow and hand
· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies,
and carpal/metacarpal osteotomies.
These procedures may be indicated as part of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Variable Pitch Compression Screw System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Julie Largent
Regulatory Affairs Specialist
305-269-6391 |
| Date: | March 3, 2016 |
| Subject Device: | Trade Name: Biomet Variable Pitch Compression Screw System
Common Name: Screw, Fixation, Bone
Classification Name: |
- HWC Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Legally marketed devices to which substantial equivalence is claimed:
- EBI, LLC+ BioDrive Micro - K092670
Device Description
The Biomet Variable Pitch Compression Screw System offers headless, cannulated compression screws in three different diameters in various lengths. The screws are manufactured from Titanium Alloy (ASTM F136) and are either color anodized or passivated for ease of size identification. The system will also include instrumentation to aid the user in alignment and stabilization of fractures to the skeletal system.
Intended Use and Indications for Use
The Variable Pitch Compression Screw System is indicated for alignment and stabilization of small bone fractures.
Specifically:
-
. Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, non-unions, or mal-unions
-
Ligament reconstruction
-
Osteochondritis dissecans
-
Arthrodesis of the foot, ankle, wrist, elbow and hand
-
K092670 is officially registered under EBI, LLC D/B/A Biomet Trauma
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Image /page/4/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The word is presented in a straightforward, unadorned manner, with no additional design elements or background distractions.
- . Small bone osteotomies, including first metatarsal head osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies.
These procedures may be indicated as part of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- . Intended Use: The Intended Use of the Biomet Variable Pitch Compression Screw System is the same as the intended uses cleared in the predicate BioDrive Micro Screws, K092670.
- Indications for Use: The Indications for Use of the Biomet Variable Pitch Compression Screw System are the same as the predicate device.
- . Materials: The Biomet Variable Pitch Compression Screw System screws are manufactured from Titanium Alloy (Ti-6Al-4V ELI ASTM F136) and the predicate screws are similarly manufactured from a Titanium alloy. The screws are either passivated or color anodized for ease of identification.
- Design Features: The design features for the Biomet Variable Pitch Compression Screw System are similar to currently marketed devices cleared in K092760 including the size (diameter), length, cannulation, and pitch. The design differences have not identified any issues that would impact the safety and effectiveness of the devices.
- . Sterilization: The implants are offered to the user either in the sterile or non-sterile configuration. The non-sterile devices will be required to be steam sterilized by the user prior to use while the sterile implants will be terminally sterilized by gamma irradiation. These sterilization configurations are the same as the predicate devices currently marketed and cleared via K092670.
Summary of Performance Data (Nonclinical and/or Clinical)
- Non-Clinical Tests
- Non-clinical performance testing included mechanical testing to ASTM F543 to o determine substantial equivalence of the Biomet Variable Pitch Compression Screw System. Results indicate that the subject system is substantially equivalent to legally marketed devices.
- Clinical Tests
- No clinical tests are provided for basis of substantial equivalence. o
Substantial Equivalence Conclusion
The Biomet Variable Pitch Compression Screw System has shown to be substantially equivalent to the predicate device. Results of non-clinical tests and the similarities with legally marketed predicate devices indicate the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.