(36 days)
Not Found
No
The 510(k) summary describes a purely mechanical, bioabsorbable screw for ACL reconstruction and makes no mention of AI or ML technology.
No
This device is an interference screw system used for surgical fixation of grafts in ACL reconstruction. Its function is mechanical support, not therapeutic treatment of a disease or condition.
No
The device is described as an "Interference Screw System" intended for surgical reconstruction of the ACL, specifically for fixation of grafts. It's an implant or surgical tool, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical screw made from an absorbable polymer, intended for surgical implantation. It is a hardware device, not software.
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. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "Bioabsorbable Interference Screw System" intended for "surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee." This is a device used within the body during surgery to fix grafts.
- Lack of Diagnostic Testing: There is no mention of the device being used to perform any kind of test on a biological sample to diagnose a condition or provide health information.
The device is an implantable surgical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Stryker Bioabsorbable 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 autografts and allografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The device is provided sterile and intended for single-use only.
Product codes
HWC, MAI
Device Description
The Stryker Bioabsorbable Interference Screw System is made as a single unit from an absorbable polymer derived from Poly L-lactic acid (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN 550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10. The material, molding process, sterilization process for the line extension is equivalent to the predicate device, the Stryker Bioabsorbable 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)
When comparing insertion torque and pullout test results, the line extension device has substantially equivalent performance to the predicate device, and is considered substantially equivalent to the Stryker Bioabsorbable Interference Screw System.
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
NOV 1 3 2003
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 "s" and "t" connected. The word "ENDOSCOPY" is in a smaller, sans-serif font and is located below the word "stryker". There is a registered trademark symbol to the right of the "r" in "stryker".
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name:
Common and Usual Name: Proprietary Name:
Screw, Fixation, Bone 21 CFR §888.3040, Class II Bioabsorbable Interference Screw Stryker Bioabsorbable Interference Screw System
Predicate Device
Stryker Bioabsorbable Interference Screw System, (#K993166), currently marketed by Stryker Endoscopy (San Jose, CA).
Summary
The Stryker Bioabsorbable Interference Screw System is for use in surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL autografts and allografts, including the patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The Stryker Bioabsorbable Interference Screw System is made as a single unit from an absorbable polymer derived from Poly L-lactic acid (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN 550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The material, molding process, sterilization process for the line extension is equivalent to the predicate device, the Stryker Bioabsorbable Interference Screw System.
The Stryker Bioabsorbable Interference Screw System is substantially equivalent in material of construction, overall design, intended use, safety, and efficacy to the Stryker Bioabsorbable Interference Screw System (#K993166) currently in commercial distribution. When comparing insertion torque and pullout test results, the line extension device has substantially equivalent performance to the predicate device, and is considered substantially equivalent to the Stryker Bioabsorbable Interference Screw System.
Contact:
Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 (408) 754-2148
October 1, 2003 Date:
1
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 the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure with three faces in profile, layered on top of each other, with flowing lines representing a ribbon or fabric.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2003
Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K033252
Trade Name: Stryker Bioabsorbable ACL Screw - Addition of 12 x 35 mm screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC. MAI Dated: October 1, 2003 Received: October 17, 2003
Dear Ms. Murphy:
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.
2
Page 2 – Ms. Melissa Murphy
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. 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-_. 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.
Mark N. Melkerson
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
3
October 1, 2003
KO 3 510(k) Number if known: 3 2 5
INDICATION FOR USE:
The Stryker Bioabsorbable 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 autografts and allografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The device is provided sterile and intended for single-use only.
R. Mark A. Mulkeran
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K033
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