(76 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI/ML terms or functionalities.
No
The device, the DePuy Mitek Tibial Tapered Screw and Tibial Sheath, is described as materials used for fixation of soft tissue grafts during cruciate ligament reconstruction, serving a mechanical and structural purpose rather than directly treating or preventing disease.
No
The device description indicates it is used for fixation of soft tissue grafts during cruciate ligament reconstruction, functioning to secure grafts. This is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description explicitly details physical components (screw, sheath, instrumentation) and performance studies (torque, pullout strength) related to hardware, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of soft tissue grafts during cruciate ligament reconstruction." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device components (screw and sheath) and their function (expanding to compress a graft) are all related to mechanical fixation within the body.
- 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 samples, 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) for surgical fixation.
N/A
Intended Use / Indications for Use
The DePuy Mitek Tibial Tapered Screw and Tibial Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The proposed INTRAFIX System consists of two components, a non-absorbable INTRAFIX Expansion Sheath and a non-absorbable INTRAFIX Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.
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, such as, Torque Capability and Pullout Strength testing were performed on the implant and its predicate device. Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
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.
0
K 122123 ( 112)
OCT
Image /page/0/Picture/1 description: The image shows the DePuy Synthes logo. The logo includes the company name, "DePuy", in a stylized font, with a circle to the left of the name. Below the name, it says "Mitek Inc." and "a Johnson & Johnson company". To the right of the logo, it says "never stop moving" in a smaller font.
INTRAFIX® PEEK Tapered Screw PRODUCT: SUBMISSION DATE: July 17, 2012 SUBMISSION TYPE: TRADITIONAL
ATTACHMENT 1 510(k) SUMMARY - INTRAFIX PEEK TAPERED SCREW
SUBMITTER'S NAME AND ADDRESS
DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
CONTACT PERSON
Julie Vafides Regulatory Affairs Specialist II DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
TELEPHONE 508-977-6645 508-977-6911 FACSIMILE jvafides@its.jnj.com E-MAIL DATE PREPARED 7/17/2012
NAME OF MEDICAL DEVICE COMMON CLASSIFICATION NAME
Fastener, Fixation, Nondegradable, Soft Tissue
PROPRIETARY NAME
INTRAFIX® PEEK Tapered Screw
SUBSTANTIAL EQUIVALENCE
INTRAFIX PEEK Tapered Screws are substantially equivalent to the following devices.
- INTRAFIX® Tapered Screws (K983560) Modified Device . (previously known as Intraturnel Fixation Fastener, cleared January 28, 1999)
- K063577 Femoral INTRAFIX® Screw and Sheath .
FDA PRODUCT CODE MBI
MBI
DEVICE CLASSIFICATION
This type of fixation screw was originally classified as a Class II medical device by the Orthopedic Review Panel, regulated as 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.
1
Image /page/1/Picture/1 description: The image shows the DePuy Mitek Inc. logo. The logo includes the DePuy name in a bold, sans-serif font, with a circle to the left of the name. Below the name, it says "Mitek Inc." and "a Johnson & Johnson company". To the right of the logo, it says "never stop moving" in a smaller, italicized font.
INTRAFIX® PEEK Tapered Screw PRODUCT: SUBMISSION DATE: July 17, 2012 SUBMISSION TYPE: TRADITIONAL
ATTACHMENT 1 510(k) SUMMARY - INTRAFIX TAPERED SCREW
DEVICE DESCRIPTION
The proposed INTRAFIX System consists of two components, a non-absorbable INTRAFIX Expansion Sheath and a non-absorbable INTRAFIX Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.
INDICATIONS FOR USE
The DePuy Mitek Tibial Tapered Screw and Tibial Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
TECHNOLOGICAL CHARACTERSTICS
The proposed INTRAFIX PEEK Tapered Screws are similar in design and indication to the predicate INTRAFIX Tapered Screws. The proposed INTRAFIX PEEK Tapered Screws are manufactured out of PEEK (polyetheretherketone), a non-absorbable radiolucent high strength thermoplastic material. The proposed PEEK material is a well-known material with a long and safe use in medical devices. A similar PEEK material is used in manufacturing the screw component of the predicate Femoral INTRAFIX Screw and Sheath (K063577).
NONCLINICAL TESTING
Verification activities, such as, Torque Capability and Pullout Strength testing were performed on the implant and its predicate device.
SAFETY AND PERFORMANCE
Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed INTRAFIX PEEK Tapered Screws have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OCT
DePuv Mitek Incorporated, a iohnson and johnson company % Ms. Julie Vafides Regulatory Specialist II 325 Paramount Drive Raynham. Massachusetts 02767
Re: K122123
Trade/Device Name: INTRAFIX® PEEK Tapered Screw Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 17, 2012 Received: July 18, 2012
Dear Ms. Vafides:
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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2012
3
Page 2 - Ms. Julie Vafides
forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
erely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K122123(11)
Image /page/4/Picture/1 description: The image shows the DePuy Mitek Inc. logo with the tagline "never stop moving." The logo is black and white and features the DePuy name in a bold font. The tagline is in a smaller, italicized font. The image is simple and clean, with a focus on the company's branding.
INTRAFIX® PEEK Tapered Screw PRODUCT: SUBMISSION DATE: July 17, 2012 SUBMISSION TYPE: TRADITIONAL
ATTACHMENT 2 INDICATIONS FOR USE
510(k) Number (if known):
Device Name: INTRAFIX® PEEK Tapered Screw
Indications for Use: The DePuy Mitek Tibial Tapered Screw and Tibial Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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) Page 1 of
ht
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122123
46 of 93 | P a g e