(56 days)
Not Found
No
The description focuses on the mechanical function of a surgical implant and associated manual instruments, with no mention of AI/ML terms or functionalities.
No
The device is described as an implant used for fixation of soft tissue grafts during cruciate ligament reconstruction, which is a structural and mechanical function rather than a therapeutic one (e.g., delivering a drug, altering a physiological process).
No
The device is an implant used for fixation of soft tissue grafts during surgical reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a two-part system consisting of physical implants (screw and sheath) and manual surgical instruments, which are hardware components.
No, 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 in vivo (within the body) to repair a ligament.
- Device Description: The device is described as "non-absorbable implants used to secure soft tissue grafts to the bone." This clearly indicates a physical implant used during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The description clearly points to a surgical implant used directly on the patient's body, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The Femoral Intrafix Screw and Sheath are non-absorbable implants used to secure soft tissue grafts to the bone during cruciate ligament reconstruction. The two-part system consists of an expandable sheath that is inserted into the center of the tunnel. The sheath separates the graft strands and places them against the tunnel wall. The screw is inserted into the center of the expansion sheath.
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)
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 Femoral Intrafix Screw and Sheath has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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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SECTION 2 – 510(k) SUMMARY
Femoral Intrafix Screw and Sheath
| JAN 2 5 2007 | |
|---|---|
| Submitter's Name and | |
| Address: | DePuy Mitek |
| a Johnson & Johnson company | |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Contact Person | Ruth C. Forstadt |
| Project Management Lead, Regulatory Affairs | |
| DePuy Mitek | |
| a Johnson & Johnson company | |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Telephone: 508-977-3988 | |
| Facsimile: 508-828-3750 | |
| e-mail: rforstad@dpyus.jnj.com | |
| Name of Medical Device | Classification Name: Fastener, Fixation, Nondegradable, Soft |
| Tissue Smooth or threaded metallic bone | |
| fixation fasteners | |
| Common/Usual Name: Orthopedic Screw, Fixation Device | |
| Proprietary Name: Femoral Intrafix Screw and Sheath | |
| Substantial Equivalence | The Femoral Intrafix Screw and Sheath is substantially equivalent to: |
| Intrafix Screw and Sheath (K983560); the Milagro Interference Screw | |
| (K032717) and the Bio-Intrafix Screw and Sheath (K032167). | |
| Device Classification | This device carries an FDA product code MBI and HWC, and is |
| classified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth or | |
| threaded metallic bone fixation fasteners under 21 CFR 888.3040. | |
| Device Description | The Femoral Intrafix Screw and Sheath are non-absorbable implants |
| used to secure soft tissue grafts to the bone during cruciate ligament | |
| reconstruction. The two-part system consists of an expandable sheath | |
| that is inserted into the center of the tunnel. The sheath separates the | |
| graft strands and places them against the tunnel wall. The screw is | |
| inserted into the center of the expansion sheath. |
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sheath and compresses the tissue against the bone. This device system
consists of the following components:
Femoral Intrafix Screws and Sheaths in various sizes
*Various manual surgical instruments
- The various manual surgical instruments are Class I exempt (per 21
CFS 888.4540 "Orthopaedic Manual Surgical Instruments) stand-alone
instruments used as an aide during the surgical application.
| Indications for Use | Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction. |
|---|---|
| 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 Femoral Intrafix Screw and Sheath has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Mitek A Johnson & Johnson company % Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
JAN 2 5 2007
Re: K063577
Trade/Device Name: Femoral Intrafix Screw and Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI and HWC Dated: November 29, 2006 Received: November 30, 2006
Dear Ms. Forstadt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 – Ms. Ruth C. Forstadt
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Names: Femoral Intrafix Screw and Sheath
The Femoral Intrafix Screw and Sheath is 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 _______
(Division Sign-Off)
Division of General Restorative,
and Neurological Devices
| 510(k) Number | 1063577 |
|---|---|
| --------------- | --------- |
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