(71 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is an implant used for fixation in ACL reconstruction, which aligns with the definition of a therapeutic device.
No.
The document describes a surgical implant system for ACL reconstruction, not a device used to diagnose medical conditions.
No
The device description explicitly states it consists of an implant (interference screw and cross pin) and associated instruments for installation, all made of Ti-6AI-4 V ELI per ASTM F136. This indicates 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.
- Device Function: The Stryker Cross-Pinned Interference Screw System is an implantable device used in surgical procedures to fix grafts during ACL reconstruction. It is a physical device inserted into the body, not a tool for analyzing biological samples.
- Intended Use: The intended use clearly states "surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts." This describes a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, the Stryker Cross-Pinned Interference Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Cross-Pinned Interference Screw 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 Stryker Cross-Pinned Interference Screw 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.
Product codes (comma separated list FDA assigned to the subject device)
JDW
Device Description
The Stryker Cross-Pinned Interference Screw consists of an implant and associated instruments for installation of the implant. The implant consists of two components: an interference screw and a cross pin. 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 Cross-Pinned Interference Screw is equivalent in intended use, safety, and efficacy to the predicate device. The cadaver testing showed a significant strength increase of both the yield load and the ultimate load. The material of construction is Ti-6AI-4 V ELI per ASTM F136.
The Stryker Cross-Pinned Interference Screw System does not raise new issues when compared to the currently marketed predicate device. Therefore, it is considered substantially equivalent to the Stryker Wedge Interference Screw System.
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
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)
The cadaver testing showed a significant strength increase of both the yield load and the ultimate load.
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
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters are 'K', 'O', '1', '2', '2', '7', and '0'. The characters are written in black ink on a white background. The handwriting is somewhat messy, but the characters are still legible.
Image /page/0/Picture/2 description: The image shows the logo for Stryker Endoscopy. The word "Stryker" is in a bold, sans-serif font, with the letters connected. Below the word "Stryker" is the word "ENDOSCOPY" in a smaller, sans-serif font. The logo is black and white.
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name:
Smooth or Threaded Metallic Bone Fixation Fasteners: 21 CFR §888.3040, Class II Threaded Fixation Pin (87 JDW) Stryker Cross-Pinned Interference Screw
Common and Usual Name: Proprietary Name:
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 Cross-Pinned Interference Screw 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 Cross-Pinned Interference Screw consists of an implant and associated instruments for installation of the implant. The implant consists of two components: an interference screw and a cross pin. 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 Cross-Pinned Interference Screw is equivalent in intended use, safety, and efficacy to the predicate device. The cadaver testing showed a significant strength increase of both the yield load and the ultimate load. The material of construction is Ti-6AI-4 V ELI per ASTM F136.
The Stryker Cross-Pinned Interference Screw System does not raise new issues when compared to the currently marketed predicate device. Therefore, it is considered substantially equivalent to the Stryker Wedge Interference Screw System.
Contact:
Date: July 10, 2001
Alisa Miller Quality Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051 (408) 567-9100 x.2259
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2001
Ms. Alisa Miller Quality Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051
Re: K012270
Trade/Device Name: Stryker Cross-Pinned Interference Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDW Dated: July 10, 2001 Received: July 19, 2001
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.
2
Page 2 - Ms. Alisa Miller
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 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,
Sincerely yours,
Mark N Milkersen
Celia M. Witten. Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
June 22, 2001
510(k) Number if known: K012270
INDICATION FOR USE:
The Stryker Cross-Pinned Interference Screw 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. Mulhausen
Restorative and Neurological Devices 012270
510(k) Number_