(73 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a metallic bone screw, with no mention of AI or ML.
Yes
The device is described as an "Interference Screw" used for the "fixation of patellar bone grafts in ACL reconstruction," which indicates it is used to treat or manage a medical condition, specifically an injury to the anterior cruciate ligament.
No
The descriptions indicate the device is a metallic bone screw used for fixation of patellar bone grafts in ACL reconstruction. Its function is to provide mechanical fixation, not to diagnose a condition.
No
The device description clearly states it is a "metallic bone screw," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of patellar bone grafts in ACL reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "metallic bone screws used to provide fixation of patellar bone-tendon-bone grafts during anterior cruciate ligament (ACL) repair." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Titanium Interference Screws are intended for use in fixation of patellar bone grafts in ACL reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI
Device Description
Titanium Interference Screws are metallic bone screws used to provide fixation of patellar bone-tendon-bone grafts during anterior cruciate ligament (ACL) repair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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: Cyclic loading testing of Titanium Interference Screws was performed to verify cyclic performance of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. Failure torque testing of Titanium Interference Screws was performed to verify the failure torque of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. Insertion torque testing of Titanium Interference Screws was performed to verify the insertion torque of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. Pull out strength testing of Titanium Interference Screws was performed to verify the pull out strength of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. Bacterial Endotoxins Test (BET) per ANSI/AAMI ST 72:2011 as a part of cleaning validation was performed, demonstrating that the device meets the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices -Bacterial Endotoxin and Pyrogen Tests. The testing indicates that the device performs within the intended use and did not raise any new safety and efficacy issues.
Clinical Tests: None provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 888.3040 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
February 24, 2020
Biomet Inc. Saveetha Raghupathi Regulatory Affairs Specialist 56 East Bell Drive. PO Box 587 Warsaw, Indiana 46581
Re: K193451
Trade/Device Name: Titanium Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: December 12, 2019 Received: December 13, 2019
Dear Saveetha Raghupathi:
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. Although this letter refers to your product as a device, please be aware 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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose, PhD Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Titanium Interference Screws
Indications for Use (Describe)
Titanium Interference Screws are intended for use in fixation of patellar bone grafts in ACL reconstruction.
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 Titanium Interference 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 September 13, 2019.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Saveetha Raghupathi
Regulatory Affairs Specialist
Telephone: (877-652-0830 ext. 236) |
| Secondary Contact Person: | Jared Cooper
Regulatory Affairs Manager
Telephone: (574-372-1941) |
| Date: | December 12, 2019 |
| Subject Device: | Trade Name: Titanium Interference Screws
Common Name: Bone Screw Fixation Device |
| | Classification Name: |
| | HWC- Screw, Fixation, Bone, Smooth or Threaded Metallic Bone Fixation Fastener (21CFR 888.3040)MBI - Fastener, Fixation, Nondegradable, Soft Tissue, Smooth or Threaded Metallic Bone Fixation Fastener (21CFR 888.3040) |
Predicate Device(s):
| Primary Predicate | 510(k) Number |
|---|---|
| Arthrotek Interference Screw | K934469 |
| Purpose and Device | Titanium Interference Screws are metallic bone screws used |
|---|---|
| Description: | to provide fixation of patellar bone-tendon-bone grafts |
| during anterior cruciate ligament (ACL) repair. | |
| To submit a 510(k) for cumulative changes made to the system since original clearance: A line extension including part numbers with minor dimensional changes made to screw design; Manufacturing site location change; To update labeling in order to bring the Instructions for Use up to current practices. | |
| Intended Use and | |
| Indications for Use: | These devices are intended for soft tissue repair and/or reconstruction. |
Titanium Interference Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction. |
| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on consideration of the following characteristics: Intended Use: Identical to predicate Indications for Use: Identical to predicate Materials: Identical to predicate Design Features: Similar to predicate Sterilization: Identical to predicate |
| Summary of Performance Data:
(Nonclinical and/or Clinical) | Non-Clinical Tests: Cyclic loading testing of Titanium Interference Screws was performed to verify cyclic performance of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. Failure torque testing of Titanium Interference Screws was performed to verify the failure torque of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. Insertion torque testing of Titanium Interference Screws was performed to verify the insertion torque of the device. The test results indicate the device and the modifications do not introduce any new risks to the device performance. |
The purpose of this submission is:
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- Pull out strength testing of Titanium Interference . Screws was performed to verify the pull out strength of the device. The test results indicate the device and the modifications do not introduce any new risks to
5
the device performance.
- Bacterial Endotoxins Test (BET) per ANSI/AAMI ST 72:2011 as a part of cleaning validation was performed, demonstrating that the device meets the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices -Bacterial Endotoxin and Pyrogen Tests.
The testing indicates that the device performs within the intended use and did not raise any new safety and efficacy issues.
Clinical Tests:
-
None provided .
The subject device, Titanium Interference Screws, has identical intended use and indications for use to the predicate device. The subject device has similar technological characteristics to the predicate, and the information provided herein demonstrates that: -
any differences do not raise new questions of safety and effectiveness: and
-
the subject device is at least as safe and effective as ● the legally marketed predicate device.
Substantial Equivalence Conclusion: