(121 days)
No
The device description and performance studies focus on the mechanical properties and fixation strength of titanium buttons and sutures, with no mention of AI or ML.
Yes.
The device is intended for fixation of soft tissue to bone for various orthopedic indications, which directly addresses medical conditions and supports treatment or restoration of body function.
No
Explanation: The device description and intended use clearly state that this is a surgical implant designed for fixation of soft-tissue to bone. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is a titanium button implant with pre-attached sutures, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being for the fixation of soft-tissue to bone in orthopedic procedures. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as a "cortical fixation device" and "titanium button implant." These are physical implants used in surgery.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The RIGIDLOOP Titanium Button is intended for fixation of soft-tissue to bone for the following indications when used with PERMATAPE™ 2.5mm Suture, #2 ORTHOCORD® Suture, #2 DYNACORD™ Suture, or equivalent nonabsorbable or partially-absorbable high strength operative suture:
Shoulder:
Acromioclavicular repair
Pectoralis major / minor repair(1)
Biceps tenodesis
Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Cruciate ligament reconstruction (1)
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair(2)
(1) PERMATAPE 2.5mm suture must be used for pectoralis major/minor repair and cruciate ligament reconstruction
(2) Size 0 or size 2/0 ORTHOCORD Suture may be used for meniscal root repair.
RIGIDLOOPTM Cortical Fixation System XL Implant
When used in conjunction with the RIGIDLOOP Cortical Fixation System, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft tissue to bone in orthopaedic procedures such as ACL repairs.
When used in conjunction with the RIGIDLOOP Titanium Button, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft-tissue to bone for the following indications:
Shoulder:
Pectoralis major / minor repair
Biceps tenodesis
Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Cruciate ligament reconstruction
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair
Product codes
MBI
Device Description
RIGIDLOOP Titanium Button
The proposed RIGIDLOOP Titanium Button is a cortical fixation device that provides a means of fixation of soft tissue to bone in orthopedic reconstructive surgery. The device consists of a titanium button implant that is provided with pre-attached leading and trailing sutures that are non-implantable. The white leading utility suture is composed of UHMWPE (device high molecular weight polyethylene) and the green trailing suture is composed of #5 Ethibond®. This device is provided sterile and is for single use only.
RIGIDLOOP Cortical Fixation System XL Implant
The RIGIDLOOP XL Implant is an extra-large titanium button implant that is currently intended for use with the already cleared RIGIDLOOP Cortical Fixation System devices (K130814). The RIGIDLOOP XL Implant can now also be used with the proposed RIGIDLOOP Titanium Button for the proposed indications. The RIGIDLOOP XL Implant is used in cases of cortical breaching. This device is provided sterile and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Knee
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)
Verification activities have been performed on the proposed RIGIDLOOP Titanium button, when used as a standalone device, when used in conjunction with the currently marketed RIGIDLOOP Cortical Fixation System XL Implant, and also on the chosen predicates. Performance testing included an evaluation of fixation strength. The testing demonstrated substantial equivalence of device performance. Safety evaluations were conducted to address biological, sterility, packaging and shelf-life testing. Bacterial Endotoxin Testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits. No animal or clinical studies were required. The proposed device has raised no new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ARTHREX PEC REPAIR BUTTON, LARGE PEC BUTTON, BICEP BUTTON, PROXIMAL BICEPS BUTTON, (Arthrex: K123341), SWIVELOCK (Arthrex: K173845)
Reference Device(s)
RIGIDLOOP CORTICAL FIXATION SYSTEM, (Depuy Mitek a Johnson & Johnson Company: K130814)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
Medos International SARL % LeeAnn Walosin Regulatory Affairs Specialist DePuy Mitek, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K190774
Trade/Device Name: RIGIDLOOP™ Titanium Button, RIGIDLOOP™ Cortical Fixation System XL Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 27, 2019 Received: June 28, 2019
Dear LeeAnn Walosin:
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.
1
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 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 (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.
Laurence D. Coyne, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K190774
Device Name RIGIDLOOP™ Titanium Button RIGIDLOOP™ Cortical Fixation System XL Implant
Indications for Use (Describe)
The RIGIDLOOP Titanium Button is intended for fixation of soft-tissue to bone for the following indications when used with PERMATAPE™ 2.5mm Suture, #2 ORTHOCORD® Suture, #2 DYNACORD™ Suture, or equivalent nonabsorbable or partially-absorbable high strength operative suture:
Shoulder: Acromioclavicular repair Pectoralis major / minor repair(1) Biceps tenodesis
Elbow: Ulnar or radial collateral ligament reconstruction Biceps tendon reattachment
Knee: Cruciate ligament reconstruction (1) Extracapsular repair: MCL, LCL, and Posterior oblique ligament Patellar tendon repair Meniscal root repair(2)
(1) PERMATAPE 2.5mm suture must be used for pectoralis major/minor repair and cruciate ligament reconstruction (2) Size 0 or size 2/0 ORTHOCORD Suture may be used for meniscal root repair.
RIGIDLOOPTM Cortical Fixation System XL Implant
When used in conjunction with the RIGIDLOOP Cortical Fixation System, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft tissue to bone in orthopaedic procedures such as ACL repairs.
When used in conjunction with the RIGIDLOOP Titanium Button, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft-tissue to bone for the following indications:
Shoulder: Pectoralis major / minor repair Biceps tenodesis
Elbow: Ulnar or radial collateral ligament reconstruction Biceps tendon reattachment
Knee: Cruciate ligament reconstruction Extracapsular repair: MCL, LCL, and Posterior oblique ligament Patellar tendon repair Meniscal root repair
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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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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes Mitek Sports Medicine. The logo consists of a circular design with interconnected shapes in a gold color, followed by the text "DePuy Synthes" in a dark blue color. Below that, the text "MITEK SPORTS MEDICINE" is written in a smaller font size, also in dark blue. Finally, the text "COMPANIES OF Johnson & Johnson" is written in a smaller font size.
510(k) SUMMARY
RIGIDLOOP Titanium Button & RIGIDLOOP XL Implant
| Date Summary
| Prepared | March 25, 2019 | |
|---|---|---|
| Submitter's | ||
| Name and | ||
| Address | DePuy Mitek | |
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Legal | ||
| Manufacturer | Medos International SARL | |
| Chemin-Blanc 38, Case Postale | ||
| CH 2400 | ||
| Le Locle, Switzerland | ||
| Contact | ||
| Person | LeeAnn Walosin | |
| Regulatory Affairs Specialist | ||
| DePuy Mitek | ||
| a Johnson & Johnson | ||
| company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767, USA | Telephone: 612-230-9909 | |
| Facsimile: 508-977-6409 | ||
| e-mail: lswiftwa@its.jnj.com) | ||
| Name of | ||
| Medical Device | Proprietary Name: | |
| Common Name: | RIGIDLOOP™ Titanium Button; | |
| RIGIDLOOP™ Cortical Fixation | ||
| System XL Implant | ||
| Fixation Device | ||
| Device | ||
| Classification | Smooth or threaded metallic bone fixation fastener, classified as Class | |
| II, product code MBI regulated per 21 CFR 888.3040. (Orthopedic | ||
| panel) | ||
| Substantial | ||
| Equivalence | The proposed RIGIDLOOP Titanium Button and the RIGIDLOOP | |
| Cortical Fixation System XL Implant (when used with the proposed | ||
| RIGIDLOOP Titanium Button) are substantially equivalent to the | ||
| following predicate devices: |
PREDICATE DEVICES:
ARTHREX PEC REPAIR BUTTON, LARGE PEC
BUTTON, BICEP BUTTON, PROXIMAL BICEPS
BUTTON, (Arthrex: K123341) SWIVELOCK (Arthrex: K173845) REFERENCE DEVICE: RIGIDLOOP CORTICAL FIXATION SYSTEM, (Depuy
Mitek a Johnson & Johnson Company: K130814) | |
| RIGIDLOOP Titanium Button | | |
| Indications for
Use | The RIGIDLOOP Titanium Button is intended for fixation of soft-
tissue to bone for the following indications when used with
PERMATAPE™ 2.5mm Suture, #2 ORTHOCORD® Suture, #2
DYNACORD™ Suture, or equivalent nonabsorbable or partially-
absorbable high strength operative suture:
Shoulder:
Acromioclavicular repair
Pectoralis major / minor repair1
Biceps tenodesis
Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Cruciate ligament reconstruction1
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair2
1 PERMATAPE 2.5mm suture must be used for pectoralis major/minor
repair and cruciate ligament reconstruction
2 Size 0 or size 2/0 ORTHOCORD Suture may be used for
meniscal root repair. | |
| | RIGIDLOOP Cortical Fixation System XL Implant
When used in conjunction with the RIGIDLOOP Cortical Fixation
System, the RIGIDLOOP Cortical Fixation System XL Implant is
intended for fixation of soft tissue to bone in orthopedic procedures such
as ACL repairs. | |
| | When used in conjunction with the RIGIDLOOP Titanium Button, the
RIGIDLOOP Cortical Fixation System XL Implant is intended for
fixation of soft-tissue to bone for the following indications: | |
| | Shoulder:
Pectoralis major / minor repair
Biceps tenodesis | |
| | Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment | |
| | Knee:
Cruciate ligament reconstruction
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair | |
| Device
Description | RIGIDLOOP Titanium Button
The proposed RIGIDLOOP Titanium Button is a cortical fixation device
that provides a means of fixation of soft tissue to bone in orthopedic
reconstructive surgery. The device consists of a titanium button implant
that is provided with pre-attached leading and trailing sutures that are
non-implantable. The white leading utility suture is composed of
UHMWPE (device high molecular weight polyethylene) and the green
trailing suture is composed of #5 Ethibond®. This device is provided
sterile and is for single use only. | |
| | RIGIDLOOP Cortical Fixation System XL Implant
The RIGIDLOOP XL Implant is an extra-large titanium button implant
that is currently intended for use with the already cleared RIGIDLOOP
Cortical Fixation System devices (K130814). The RIGIDLOOP XL
Implant can now also be used with the proposed RIGIDLOOP Titanium
Button for the proposed indications. The RIGIDLOOP XL Implant is
used in cases of cortical breaching. This device is provided sterile and is
for single use only. | |
| Technological
Characteristics | The proposed device, the RIGIDLOOP Titanium button (when used as a
standalone system and when used in conjunction with the currently | |
| Although there are differences between the proposed device and the
predicate in the implant design, implant size, implant material, operative
sutures, and principle in operation, performance testing has
demonstrated that the proposed device is as safe and effective as the
predicates and that the differences do not raise any different questions
concerning safety and efficacy. Based on this comparison with the
predicate devices, the proposed device is considered substantially
equivalent to the predicate devices: ARTHREX PEC REPAIR
BUTTON, LARGE PEC BUTTON, BICEP BUTTON, PROXIMAL
BICEPS BUTTON, (Arthrex: K123341) and SWIVELOCK (Arthrex:
K173845).
The implant design, implant materials, and implant materials are
identical to the reference device; the principle of operation is similar
when compared to the reference device: RIGIDLOOP CORTICAL
FIXATION SYSTEM, (Depuy Mitek a Johnson & Johnson Company:
K130814). | | |
| Non-clinical
Testing | Verification activities have been performed on the proposed
RIGIDLOOP Titanium button, when used as a standalone device, when
used in conjunction with the currently marketed RIGIDLOOP Cortical
Fixation System XL Implant, and also on the chosen predicates.
Performance testing included an evaluation of fixation strength. The
testing demonstrated substantial equivalence of device performance.
Safety evaluations were conducted to address biological, sterility,
packaging and shelf-life testing. Bacterial Endotoxin Testing has been
completed and results have demonstrated that the proposed devices meet
the endotoxin limits. No animal or clinical studies were required. The
proposed device has raised no new issues of safety and efficacy. | |
| Safety and
Performance | Results of the performance testing have demonstrated that the proposed
devices are suitable for their intended use.
Based on similarities in the indications for use, technological
characteristics, and performance in comparison to the predicate devices,
the proposed device is considered substantially equivalent to the
predicate devices. | |
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Image /page/5/Picture/1 description: The image displays the logo for DePuy Synthes Mitek Sports Medicine. The text "DePuy Synthes" is in a bold, sans-serif font, with "MITEK SPORTS MEDICINE" appearing in a smaller font size below it. Underneath this, the phrase "COMPANIES OF Johnson-Johnson" is present, with the Johnson & Johnson logo in a stylized script.
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Image /page/6/Picture/1 description: The image contains the logo for DePuy Synthes Mitek Sports Medicine. The logo consists of a circular graphic to the left of the text "DePuy Synthes" in a dark blue font. Below that, the text "MITEK SPORTS MEDICINE" is present. Underneath a thin line, the text "COMPANIES OF Johnson-Johnson" is written in a smaller font size.
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Image /page/7/Picture/1 description: The image contains the logo for DePuy Synthes Mitek Sports Medicine. The logo consists of a circular graphic to the left of the text "DePuy Synthes" in a dark blue font. Below that is the text "MITEK SPORTS MEDICINE" in a smaller, lighter blue font. Underneath that is the text "COMPANIES OF Johnson & Johnson" in a small font.
has the same intended use and indications as the predicate devices.