(129 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional testing, with no mention of AI or ML.
Yes
The device is described as a "titanium implant designed to provide fixation in the repair of tendons and ligaments," specifically for procedures like "ACL repair," which directly addresses and treats a medical condition.
No
The device is described as an implantable titanium system for fixation of soft tissue to bone in orthopedic procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "machined titanium implant" and includes "reamers and depth gauges" as accessories, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- RIGIDLOOP System Function: The RIGIDLOOP Cortical Fixation System is a surgical implant used to physically fix soft tissue to bone during orthopedic procedures. It is a mechanical device that is placed inside the body.
- Lack of Specimen Analysis: The description clearly states the device is used for fixation in orthopedic procedures. There is no mention of analyzing any biological specimens.
The information provided describes a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The RIGIDLOOP Cortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments. It consists of a titanium implantable button with a pre-attached non-absorbable fiber loop. This implantable fiber loop has non-absorbable suture attached to the button for assisting in the button placement and is discarded after the device placement. The device is offered in size ranges of 15-60mm in 5mm increments. Reamers and depth gauges are provided separately as reusable accessories to assist in the placement of the RIGIDLOOP Cortical Fixation System.
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)
Verification activities were performed on the implant and / or its predicates. Testing assessments include pull out testing, shelf-life, sterilization and biocompatibility. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use.
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.
K980155 Smith & Nephew EndoButton Continuous Loop, K081098 Smith & Nephew EndoButton Continuous Loop, K060664 Fastin RC Anchors, K040004 / K042398 Orthocord suture
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.
0
.
SECTION 2 - 510(k) SUMMARY RIGIDLOOP Cortical Fixation System
| Recognized
Manufacturer: | Medos International SarL
Puits Godet 20
CH 2000 Neuchâtel
Switzerland |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Date Prepared: April 17, 2013 |
| Contact Person | Kristine Christo
Manager, Regulatory Affairs
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA |
| | AUG 1 2013
Telephone: 508-828-3359
Facsimile: 508-977-6911
e-mail: KChristo@its.jnj.com |
| Name of
Medical Device | Proprietary Name: RIGIDLOOP Cortical Fixation System
Classification Name: Fastener, Fixation, Nondegradable, Soft tissue
Common Name: Fastener, Fixation, Soft Tissue |
| Substantial
Equivalence | The RIGIDLOOP Cortical Fixation Systemis substantially equivalent to:
• K980155 Smith & Nephew EndoButton Continuous Loop
• K081098 Smith & Nephew EndoButton Continuous Loop
• K060664 Fastin RC Anchors
• K040004 / K042398 Orthocord suture |
| Device
Classification | Smooth or threaded metallic bone fixation fastener, classified as Class II, product code
MBI regulated under 21 CFR 888.3040. |
1
:
| Device
Description | The RIGIDLOOP Cortical Fixation System is a machined titanium implant designed
to provide fixation in the repair of tendons and ligaments. It consists of a titanium
implantable button with a pre-attached non-absorbable fiber loop. This implantable
fiber loop has non-absorbable suture attached to the button for assisting in the button
placement and is discarded after the device placement. The device is offered in size
ranges of 15-60mm in 5mm increments.
Reamers and depth gauges are provided separately as reusable accessories to assist in
the placement of the RIGIDLOOP Cortical Fixation System. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The proposed RigidLoop Fixation Device consists of similar materials and design as
predicate Smith & Nephew Endobutton Cl (K980155, K081098). The proposed device
principal operation is identical to predicate Smith &Nephew Endobutton CL
(K980155, K081098). The RigidLoop Cortical Fixation Device has no new
technological characteristics as compared to the predicate Smith &Nephew
Endobutton CL (K980155, K081098). |
| Indications for
Use | The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to
bone in orthopedic procedures such as ACL repair. |
| Non clinical
Testing | Verification activities were performed on the implant and / or its predicates. Testing
assessments include pull out testing, shelf-life, sterilization and biocompatibility. |
| Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are
suitable for their intended use.
Based on the indications for use, technological characteristics, and comparison to the
predicate devices, the proposed RIGIDLOOP Cortical Fixation System has shown to
be substantially equivalent to the predicate devices under the Federal Food, Drug and
Cosmetic Act. |
.
.
2
Image /page/2/Picture/0 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 or a bird-like figure with three wing-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
August 1, 2013
DePuy Mitek, Incorporated % Ms. Kristine Christo Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K130814
Trade/Device Name: RigidLoop Cortical Fixation System 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, 2013 Received: July 2, 2013
Dear Ms. Christo:
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 (2 1 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
3
Page 2 -- Ms. Kristine Christo
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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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
4
Indications for Use
510(k) Number (if known): K130814 Device Name: RigidLoop Cortical Fixation System
Indications for Use:
The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedie . procedures such as ACL repair.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _____________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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