(90 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and does not mention any AI or ML components, image processing, or data-driven performance metrics.
Yes.
The device is used to anchor soft tissue to bone during healing after reattachment procedures, which is a therapeutic function.
No
The device is a suture anchor used for reattaching soft tissue to bone, which is a therapeutic rather than diagnostic function. Its intended use and device description do not mention any diagnostic capabilities.
No
The device description clearly states it is a "non-resorbable suture anchor," which is a physical implantable device, not software. The performance studies also focus on mechanical properties of a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue reattachment procedures in the shoulder." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "non-resorbable suture anchor used to provide soft tissue fixation to bone during healing." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a surgical implant used to repair tissue within the body.
N/A
Intended Use / Indications for Use
The ALLthread™ Titanium Suture Anchor devices are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Product codes
MBI
Device Description
The ALLthread Titanium Suture Anchor is a non-resorbable suture anchor used to provide soft tissue fixation to bone during healing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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 the ALLthread Titanium Suture Anchor device was performed to verify cyclic performance of the threaded anchor implant. The test results indicate that the device and the modifications do not introduce any new risks to device performance. Static loading testing of the ALLthread Titanium Suture Anchor device was performed to verify the pull out strength of the device. The test results indicate that the device and the modifications do not introduce any new risks to device performance. Insertion torque testing of the ALLthread Titanium Suture Anchor device was performed to verify the insertion torque of the device. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
Failure torque testing of the ALLthread Titanium Suture Anchor device was performed to verify the failure torque of the device. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
Needle attachment strength testing of the ALLthread Titanium Suture Anchor device was performed to verify the minimum force required to detach the suture from the needle. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
Suture tensile strength testing of the ALLthread Titanium Suture Anchor device was performed to verify the strength of the sutures. The test results indicate that the device and the modifications do not introduce any new risks to 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 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):
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/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2020
Biomet Inc. Jared Cooper Regulatory Affairs Manager 56 East Bell Drive, PO Box 587 Warsaw, Indiana 46581
Re: K192942
Trade/Device Name: ALthread™ Titanium Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 17, 2019 Received: October 18, 2019
Dear Jared Cooper:
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
1
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 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 (QS) 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, Ph.D. 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)
K192942
Device Name ALLthread™ Titanium Suture Anchor
Indications for Use (Describe)
The ALLthread™ Titanium Suture Anchor devices are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
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 ALLthread Titanium Suture Anchor 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 18, 2019 |
| Subject Device: | Trade Name: ALLthread™ Titanium Suture Anchor
Common Name: Soft Tissue Fixation Device
Classification Name: |
| | MBI - Fastener, Fixation, Nondegradable, Soft Tissue (21CFR 888.3040) |
Predicate Device(s):
| Primary Predicates | 510(k) Number |
|---|---|
| Ti - Screw Anchor SP | K042460 |
| ALLthread Titanium Anchor | K080088 |
| Purpose and Device
| Description: | The purpose of this submission is: |
|---|---|
| To submit a 510(k) for cumulative changes: Line extension including device configurations | |
| with 2 or 3 suture options, a white/black suture | |
| color option, and modified needle attachment | |
| options. Change in manufacturing site location and | |
| sterilization site location. | |
| To update labeling in order to narrow the Indications for | |
| Use statements and bring the Instructions for Use up to | |
| current practices. | |
| The ALLthread Titanium Suture Anchor is a non-resorbable | |
| suture anchor used to provide soft tissue fixation to bone | |
| during healing. | |
| Intended Use and | |
| Indications for Use: | The ALLthread Titanium Suture Anchor is intended for use |
| in soft tissue fixation. |
The ALLthread™ Titanium Suture Anchor devices are
indicated for use in soft tissue reattachment procedures in
the shoulder. Specific indications for the shoulder include:
Bankart repair, SLAP lesion repair, acromio-clavicular
separation, rotator cuff repair, capsule repair or
capsulolabral reconstruction, biceps tenodesis, deltoid
repair. |
| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on
consideration of the following characteristics:
Intended Use: Similar to predicate Indications for Use: Similar to predicate Materials: Similar to predicate Design Features: Similar to predicate Sterilization: Similar to predicate |
| Summary of Performance Data:
(Nonclinical and/or Clinical) | Non-Clinical Tests:
Cyclic loading testing of the ALLthread Titanium
Suture Anchor device was performed to verify cyclic
performance of the threaded anchor implant. The test
results indicate that the device and the modifications
do not introduce any new risks to device
performance. Static loading testing of the ALLthread Titanium
Suture Anchor device was performed to verify the
pull out strength of the device. The test results
indicate that the device and the modifications do not |
4
- introduce any new risks to device performance. . Insertion torque testing of the ALLthread Titanium Suture Anchor device was performed to verify the insertion torque of the device. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
- Failure torque testing of the ALLthread Titanium ●
5
Suture Anchor device was performed to verify the failure torque of the device. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
- Needle attachment strength testing of the ALLthread Titanium Suture Anchor device was performed to verify the minimum force required to detach the suture from the needle. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
- Suture tensile strength testing of the ALLthread ● Titanium Suture Anchor device was performed to verify the strength of the sutures. The test results indicate that the device and the modifications do not introduce any new risks to 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 proposed ALLthread Titanium Suture Anchor has similar intended use and indications for use as the predicate devices. The proposed devices have similar technological characteristics to the predicates, and the information provided herein demonstrates that: -
any differences do not raise new questions of safety ● and effectiveness; and
-
the proposed devices are at least as safe and effective as the legally marketed predicate devices.
Substantial Equivalence Conclusion: