(44 days)
Not Found
Not Found
No
The summary describes a purely mechanical implant (titanium screw) and contains no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is used for "tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction," which is a therapeutic intervention.
No
Explanation: The device description states its intended use is for "tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction," which is a treatment or reconstructive function, not a diagnostic one.
No
The device description explicitly states it is composed of titanium, indicating it is a physical hardware 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- MegaFix-T™ Function: The MegaFix-T™ Titanium Interference Screw is a surgical implant used to physically fix tendon grafts within the body during ligament reconstruction. It is a structural device, not a diagnostic tool that analyzes biological samples.
The provided information clearly describes a device used within the body for surgical repair, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.
Product codes
HWC
Device Description
The MegaFix-T™ is composed of titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibial and femoral
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 shows a logo for "STORZ". The logo is in white against a black background. The letter "O" in the logo is replaced by a black circle with a smaller white circle inside. Below the main logo, there is smaller text that reads "Karl Storz Endoscopy".
Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe 5th Floor Culver City, California 90230-7600 Phone 310 338 8100
Toll Free 800 421 0837 Fax 310 410 5527
K030368
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 338-8100 | MAR 20 2003 |
|------------------------|---------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Mario T. Marcelo
Regulatory Affairs Associate | |
| Device Identification: | Common Name:
Cannulated Titanium Interference Screw | |
| | Trade Name: (optional)
Karl Storz MegaFix TTM Titanium Interference Screw | |
Indication: The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.
Device Description: The MegaFix-T™ is composed of titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.
Substantial Equivalence: The MegaFix-T™ is substantially equivalent to the predicate devices since the basic features and intended use are similar. The minor differences between the MegaFix-TTM and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device.
Signed:
Mario T. Marcelo Regulatory Affairs Associate
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Mr. Mario T. Marcelo Regulatory Affairs Associate Karl Storz Endoscopy America, Inc 600 Corporate Pointe 5th Floor Culver City, CA 90230-7600
Re: K030368
Trade/Device Name: Karl Storz MegaFix-T™ Titanium Interference Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 31, 2003 Received: February 4, 2003
Dear Mr. Marcelo:
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 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.
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Page 2 - Mr. Mario T. Marcelo
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 marketed 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely, yours,
Mark N. Mulhern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows a logo with the word "STORY" in large, bold letters. There is a circular design element within the word, possibly replacing the letter "O". Below the word "STORY", there is another word, which appears to be "REEL". The image has a grainy or textured appearance, possibly due to the image quality or the style of the logo.
K030368
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510(k) Number (if known): Not yet assigned
Device Name: Karl Storz MegaFix-T™ Titanium Interference Screw
Indications for Use: The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: OR Over-The Counter Use: (Per 21 CFR 801.109) (Optional Format 1-2-96) 003 10(k) Number