(64 days)
Not Found
No
The description focuses on mechanical components and surgical procedures, with no mention of AI/ML terms or functionalities.
No
Explanation: The device is an implant and associated instruments for surgical fixation of ACL grafts, which is a structural support device rather than one that treats or prevents disease/conditions directly.
No
The device is used for surgical reconstruction and fixation of ligaments, not for diagnosing medical conditions.
No
The device description explicitly states it consists of an implant (hardware) and associated instruments for installation. It does not describe a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee". This describes a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is an implant (interference screw and cross pin) and associated instruments for its installation. This is a surgical device, not a diagnostic test kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to repair a physical structure in the body.
N/A
Intended Use / Indications for Use
The Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patellar tendon-tibial bone graft complex, the semitendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.
Product codes
JDW
Device Description
The Stryker Interference Screw Cross Pin System consists of an implant and associated instruments for installation of the implant. The implant consists of two components: an interference screw with cross pin hole, and a cross pin for the interference screw. The interference screw has a transverse hole in it for receipt of the cross pin. The cross pin is available for optional use by the user, in the event that adjunctive fixation is deemed appropriate. A drill guide provides alignment for drilling a hole coincident with the hole in interference screw and for receiving the cross pin.
Both implants will be provided sterile for single-use applications (ASTM 4169). These devices will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10-6. The devices are biocompatible per ISO-10993 and G95-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cruciate ligament (ACL) deficient knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical reconstruction
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)
The Stryker Interference Screw with Cross Pin is equivalent in intended use, safety, and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 the Stryker Endoscopy logo. The word "stryker" is in a bold, sans-serif font, with the "t" extending over the "r" and "y". A registered trademark symbol is located to the right of the "r". Below "stryker" is the word "ENDOSCOPY" in a smaller, sans-serif font.
K02 0097
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name:
Common and Usual Name: Proprietary Name:
Smooth or Threaded Metallic Bone Fixation Fasteners: 21 CFR §888.3040, Class II Threaded Fixation Pin (87 JDW) Stryker Interference Screw Cross Pin System
Predicate Device
Stryker Wedge Interference Screw (#K972233) currently marketed by Stryker Endoscopy (Santa Clara, CA).
Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patellar tendon-tibial bone graft complex, the semitendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The interference screw fixation technique is a common method in orthopedic surgery, and has been well published in professional journals such as Arthroscopy: The Journal of Arthroscopic and Related Surgery.
The Stryker Interference Screw Cross Pin System consists of an implant and associated instruments for installation of the implant . The implant consists of two components: an interference screw with cross pin hole, and a cross pin for the interference screw. The interference screw has a transverse hole in it for receipt of the cross pin. The cross pin is available for optional use by the user, in the event that adjunctive fixation is deemed appropriate. A drill guide provides alignment for drilling a hole coincident with the hole in interference screw and for receiving the cross pin.
Both implants will be provided sterile for single-use applications (ASTM 4169). These devices will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 °. The devices are biocompatible per ISO-10993 and G95-1. The Stryker Interference Screw with Cross Pin is equivalent in intended use, safety, and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.
The Stryker Interference Screw Cross Pin System is considered substantially equivalent to the Stryker Wedge Interference Screw System.
Contact:
Date: January 4, 2002
Alisa Miller Quality Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051 (408) 567-9100 x.2259
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. 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 1 5 2002
Ms. Alisa Miller Ouality Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051
Re: K020097
Trade Name: Stryker Interference Screw Cross Pin System Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Number: 888.3040 Regulatory Class: II Product Code: JDW Dated: January 4, 2002 Received: January 10, 2002
Dear Ms. Miller:
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 - Ms. Alisa Miller
This letter will allow you to begin marketing your device as described in your Section 510(k) rms seket 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
R. Mark N. Miller
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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January 4, 2002
510(k) Number if known: K020097
INDICATION FOR USE:
The Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR
Over-the-Counter Use
Mark N Millenn
(Division Sign-Off)
Division of G and resubrative and Neurological Devices
510(k) Number K020097
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