(76 days)
STERLING® Interference Screw ST
Not Found
No
The device description and intended use describe a physical implant (interference screw) made from bovine bone. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The device is an interference screw used for fixation during ligament reconstruction, which is a structural component for support, not a device that directly treats or prevents a disease or condition. While it aids in the reconstruction process, its primary function is mechanical fixation rather than therapeutic intervention in the medical sense.
No
The device is an interference screw used for fixation during ligament reconstruction, which is a therapeutic purpose, not diagnostic.
No
The device description clearly states it is a physical screw machined from bovine bone, indicating 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The STERLING® Interference Screw HT is a physical implant made from bovine bone intended for surgical fixation during ACL and PCL reconstruction. It is used in the body, not to test samples from the body.
The description clearly indicates it's a surgical implant used for mechanical support, not a diagnostic test.
N/A
Intended Use / Indications for Use
The STERLING® Interference Screw HT is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional. The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendonbone graft; fixation during posterior cruciate ligament reconstruction utilizing a bone-tendon-bone graft.
Product codes
HWC
Device Description
The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.
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
trained medical professional
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 STERLING® Interference Screw HT has been shown to remodel comparably to allograft in an animal model. A viral inactivation study using a worstory to representation of the BioCleanse® process, used in the manifacture of STERLING® Interference Screw HT, has shown greater than a six log reduction of a panel of viruses to below detectable limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
STERLING® Interference Screw ST
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
K052405 page 142
NOV 1 6 2005
510(K) Summary
Date: August 31, 2005
Submitted by: Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4382 Fax: 386-462-3821
Proprietary Name: STERLING® Interference Screw HT
Common Name: Screw, fixation, bone
Classification: HWC, orthopedics panel
Code Section: 21 CFR 888.3040
Substantial Equivalence:
The STERLING® Interference Screw HT is equivalent to the STERLING® Interference Screw ST in materials, design, and function.
Description:
The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.
Intended Use:
The STERLING® Interference Screw HT is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional.
Summary of Technological Characteristics:
The STERLING® Interference Screw HT and the STERLING® Interference Screw ST have equivalent materials, design and function. The STERLING® Interference Screw HT is constructed of bovine bone and is equivalent in materials to another 510(k)-cleared product, the STERLING® Interference Screw ST. The source of bovine bone used in the manufacture of STERLING® Interference Screw HT is a closed herd located in the U.S.A.
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The STERLING® Interference Screw HT has been shown to remodel comparably to allograft in an animal model. A viral inactivation study using a worstory to
representation of the BioCleanse® process, used in the manifacture of STERLING® Interference Screw HT, has shown greater than a six log reduction of a panel of viruses to below detectable limits.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a river or stream. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2005
Ms. Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle P.O. Box 2650 Alachua, Florida 32615
K052405 Trade/Device Name: Sterling® Interference Screw HT Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 31, 2005 Received: September 13, 2005
Dear Ms. Hartill:
Re:
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. Carrie Hartill
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 (240) 276-0120. 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 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/industry/support/index.html
Sincerely yours,
C.C. McMullen
Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
_ 注
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Regeneration Technologies, Inc. STERLING® Interference Screw HT 510(k) Pre-market Notification
Indications for Use
510(k) Number (if known): K052405
Device Name:
STERLING® Interference Screw HT
Indications for Use: The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendonbone graft; fixation during posterior cruciate ligament reconstruction utilizing a bone-tendon-bone graft.
Over-The-Counter Use No Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
KJS 2405
(Division Sign-Off) Division of General, Restorati e, and Neurological Devices
519(k) Number上のメイン