(30 days)
No
The summary describes mechanical bone screws and associated instruments, with no mention of AI or ML capabilities.
No
This device is a surgical implant (screws) used for fixation of joints or bone reconstruction, primarily for orthopedic corrective procedures. Therapeutic devices are typically defined as those that prevent, treat, or cure a disease or condition, often through non-surgical means or by directly restoring function, rather than providing structural support during healing. While it aids in the healing process of various conditions, its primary function is mechanical support and stabilization, which is often considered a life-supporting or life-sustaining function or a general surgical instrument classification for medical devices.
No
The device is a surgical screw intended for fixation and reconstruction of bones, not for diagnosing medical conditions.
No
The device description clearly states it consists of bone screws and instruments, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of a joint (arthrodesis) or bone reconstruction (osteotomy)" of bones in the foot and hand. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "bone screws of various lengths and diameters and dimensionally optimized corresponding instruments." These are physical implants and surgical tools.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing any biological samples.
The device described is a surgical implant and associated instruments used for orthopedic procedures.
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 and 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 helps 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 breakoff cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves automatic compression at the osteotomy site.
The purpose of this submission is to introduce two new drivers to be used with the Biomet Headless Compression Screws with a decreased tip-taper length and increased radius of curvature compared to the drivers cleared in K142658.
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
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 Tests: Non-clinical performance testing including torque testing of the driver and insertion/removal torque tests were performed on the screw to compare breakage and simulated use. Results did not add any new risks regarding safety and effectiveness.
Clinical Tests: None provided as a basis for 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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February 7, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biomet Inc. Andrew Steward Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K190035
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: January 2, 2019 Received: January 8, 2019
Dear Andrew Steward:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali -S
for 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)
Device Name 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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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 Headless Compression 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 Person: | Andrew J. Steward
Regulatory Affairs Specialist
Telephone: (574-373-3314) |
| Date: | 2 January 2019 |
| Subject Device: | Trade Name: Headless Compression and Twist-Off Screws
Common Name: Screw, Fixation, Bone
Classification Name:
• HWC- Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Predicate Device(s): | K142658 Headless Compression and Twist-Off Screws Biomet Inc. |
| Purpose and Device Description: | The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters and 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 helps 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 breakoff cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves automatic compression at the osteotomy site. |
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| | The purpose of this submission is to introduce two new drivers to
be used with the Biomet Headless Compression Screws with a
decreased tip-taper length and increased radius of curvature
compared to the drivers cleared in K142658. |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. |
| 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
Headless Compression and Twist-Off Screws is the
same as those cleared in K142658. Indications for Use: The indications for use of the
Biomet Headless Compression and Twist-Off Screws
are the same as the indications for use cleared in
K142658. Materials: The materials used in the Biomet Headless
Compression and Twist-Off Screws are the same as
those cleared in K142658. Design Features: The design features of the Biomet
Headless Compression and Twist-Off Screws are the
same as those cleared in K142658. Sterilization: The sterilization method for the Biomet
Headless Compression and Twist-Off Screws is the
same as that cleared in K142658. |
| Summary of Performance Data
(Nonclinical and/or Clinical) | Non-Clinical Tests: Non-clinical performance testing including torque |
- testing of of the the driver a and failure to insertion/removal torque tests were performed on the screw to compare breakage and simulated use. Results did not add any new risks regarding safety and effectiveness.
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- Clinical Tests: ●
- o None provided as a basis for substantial equivalence.
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 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.