(56 days)
No
The summary describes mechanical bone screws and associated instruments, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not related to data analysis or image processing.
No.
The device's stated purpose is for fixation of joint or bone reconstruction, which is a structural and mechanical role rather than a therapeutic one (e.g., treating a disease or correcting a bodily dysfunction through non-mechanical means).
No
The device is described as a surgical screw used for fixation and reconstruction of bones, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the device consists of "bone screws of various lengths and diameters" and "dimensionally optimized corresponding instruments," 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 is for the fixation of joints and bone reconstruction in the foot and hand. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of bone screws and instruments used for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention.
N/A
Intended Use / Indications for Use
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
Product codes
HWC
Device Description
The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters. The Biomet Headless Compression and Twist-Off Screws are also accompanied by dimensionally optimized corresponding instruments which are used to aid in the alignment and stabilization of fractures to the skeletal system. The Biomet Headless Compression Screws are a cannulated headless screw, which is inserted below the bone surface. The Biomet Headless Compression Screw is designed to minimize soft tissue irritation and provides compression due to a dual thread design. The Biomet Twist-Off Screw is a solid one piece screw that has a direct connection to a drill or large diameter pin driver, this allows the screw to break-off cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 and engineering justifications included mechanical tests per ASTM F543 that were performed to determine substantial equivalence of the Biomet Headless Compression and Twist-Off Screws including torsional, axial pullout and driving torque. Results indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DEPUY ORTHOPAEDICS, INC-K062352, DEPUY ORTHOPAEDICS, INC-K971069, LANDOS, INC-K962233, WRIGHT MEDICAL TECHNOLOGY, INC- K082320, MEMOMETAL TECHNOLOGIES- K070039
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
Image /page/0/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 an abstract symbol resembling a stylized caduceus, with three human profiles facing right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corporation Ms. Victoria Scheitlin Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46582
November 13, 2014
Re: K142658
Trade/Device Name: Biomet Headless Compression and Twist-Off Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 9, 2014 Received: September 18, 2014
Dear Ms. Scheitlin:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Victoria Scheitlin
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/Resourcesfor You/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
2
Indications for Use
510(k) Number (if known) K142658
Device Name
Biomet Headless Compression and Twist-Off Screws
Indications for Use (Describe)
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. A horizontal line underlines the entire word, adding a sense of stability and emphasis to the brand name. The overall design is simple, clean, and professional.
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 FRS and Twist-Off Screws 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: | Victoria Scheitlin
Regulatory Affairs Specialist |
| Date: | November 12, 2014 |
| Subject Device:
Screws | Trade Name: Biomet Headless Compression and Twist-Off
Common Name: Screw, Fixation, Bone
Classification Name:
• HWC– Smooth or Threaded Metallic Bone Fixation Fastener (2
CFR 888.3040) |
Legally marketed devices to which substantial equivalence is claimed:
The Biomet Headless Compression and Twist-Off Screws are substantially equivalent to the currently marketed devices:
- DEPUY ORTHOPAEDICS, INC-K062352
- DEPUY ORTHOPAEDICS, INC-K971069
- LANDOS, INC-K962233
- WRIGHT MEDICAL TECHNOLOGY, INC- K082320
- MEMOMETAL TECHNOLOGIES- K070039
Device Description
The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters. The Biomet Headless Compression and Twist-Off Screws are also accompanied by dimensionally optimized corresponding instruments which are used to aid in the alignment and stabilization of fractures to the skeletal system. The Biomet Headless Compression Screws are a cannulated headless screw, which is inserted below the bone surface. The Biomet Headless Compression Screw is designed to minimize soft tissue irritation and provides compression due to a dual thread design. The Biomet Twist-Off Screw is a solid one piece screw that has a direct connection to a drill or large diameter pin driver, this allows the screw to break-off cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.
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Image /page/4/Picture/0 description: The image shows the word "BIOMET" in a sans-serif font. The letters are all capitalized and appear to be in a dark gray color. A thin black line is present underneath the word, spanning its entire length.
Intended Use and Indications for Use
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the midfoot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The Intended Use for the Biomet Headless Compression and Twist-Off Screws is the same as the Intended Use cleared via K062352, K962233, and K971069 and are similar to K082320 and K070039.
- Indications for Use: The Indications for Use for the Biomet Headless Compression and Twist-Off Screws is similar and based on the Indications for Use cleared via K062352, K962233, and K971069 and are similar to K082320 and K070039.
- Materials: The Biomet Headless Compression and Twist-Off Screws are fabricated from Ti 6Al-4V. Titanium alloys are commonly used materials in orthopedic implants, and is a material that was used in predicate devices cleared via K062352, K962233, K971069, K082320, and K070039.
- . Design Features: The design features of the Biomet Headless Compression and Twist-Off Screws are similar to the currently marketed devices K062352, K962233, K971069 K082320, and K070039. No issues of design differences have identified issues of safety or effectiveness.
- Sterilization: The Biomet Headless Compression and Twist-Off Screws will be offered in non-sterile and sterile by gamma irradiation. These sterilization configurations are similar to the predicate devices currently marketed via K062352, K962233, K971069, K082320, and K070039.
Summary of Performance Data (Nonclinical and/or Clinical)
- Non-Clinical Tests .
- o Non-clinical performance testing and engineering justifications included mechanical tests per ASTM F543 that were performed to determine substantial equivalence of the Biomet Headless Compression and Twist-Off Screws including torsional, axial pullout and driving torque. Results indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
- Clinical Tests
- None provided as a basis for substantial equivalence. o
Substantial Equivalence Conclusion
The Biomet Headless Compression and Twist-Off Screws have been shown to be substantially equivalent to the predicate devices. Results of preclinical tests/engineering justification and the similarities with legal marketed predicated devices indicate the device will perform within the intended use and no new issues of safety or effectiveness have been raised.