(76 days)
Not Found
BioOss Anorganic Bovine Bone
No
The summary describes a physical surgical implant (an interference screw) made from bovine bone. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No
The device is described as an interference screw used for ligament reconstruction, which provides fixation or support rather than directly treating a disease or condition for therapeutic benefit.
No
Explanation: This device, the STERLING® Interference Screw ST, is used for fixation during ligament reconstruction. Its function is to provide structural support rather than to diagnose medical conditions or identify diseases.
No
The device description clearly states it is a physical screw machined from bovine bone, indicating it is a hardware device, not software.
Based on the provided information, the STERLING® Interference Screw ST is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is an implant used to fix soft tissue grafts within bone tunnels during ligament reconstruction surgery. It is used in vivo (within the living body), not in vitro (in glass or outside the body).
- The intended use describes a surgical procedure. The description clearly states its use in anterior and posterior cruciate ligament reconstruction.
- The device description details a surgical implant. It describes a screw made from bone material, designed for insertion into bone tunnels.
Therefore, the STERLING® Interference Screw ST is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The STERLING® Interference Screw ST is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional. The STERLING® Interference Screw ST is used to provide interference fixation within femoral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft; and for interference fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 15 to 40mm and diameters ranging from 7 to 10 mm. The STERLING® Interference Screw ST is threaded, has an internal hex-drive, and has a rounded proximal head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral and/or tibial tunnels (for ACL reconstruction); Not specified (for PCL reconstruction)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professional; arthroscopic or open ACL and/or PCL 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)
Not Found
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.
Bioscrew Absorbable Interference Screw
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.
BioOss Anorganic Bovine Bone
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/0 description: The image shows the logo for Regeneration Technologies, Inc. The logo consists of a black square on the left, followed by the word "Regeneration" in large, bold, black letters. Below "Regeneration" is the text "TECHNOLOGIES, INC." in smaller, thinner, black letters.
11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA Tel 386.418.8888 Toil Free 877.343.683.3 Fax 386.418.0342 www.rtix.com
K050767 pge'41
510(K) Summary
Date: March 24, 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 ST
Common Name: Screw, fixation, bone
Classification: HWC, orthopedics panel
Code Section: 21 CFR 888.3040
Substantial Equivalence:
The STERLING® Interference Screw ST is substantially equivalent to the Bioscrew Absorbable Interference Screw in design and function, and substantially equivalent to BioOss Anorganic Bovine Bone in materials.
Description:
The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 15 to 40mm and diameters ranging from 7 to 10 mm. The STERLING® Interference Screw ST is threaded, has an internal hex-drive, and has a rounded proximal head.
Intended Use:
The STERLING® Interference Screw ST 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 ST and the BioScrew Absorbable Interference Screw have substantially equivalent design and function, but different materials. The STERLING® Interference Screw ST is constructed of bovine bone and is substantially equivalent in materials to another 510(k)-cleared product, BioOss Anorganic Bovine Bone.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN 9 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carrie Hartill Regeneration Technologies Incorporated 11621 Research Circle Alachua, Florida 32615
Re: K050767
Trade/Device Name: STERLING® Interference Screw ST Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 24, 2005 Received: March 25, 2005
Dear Ms. Hartill:
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. 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 prematted 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 11 Juan 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 Oiner general 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,
Hypt. Clude
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
CONFIDENTIAL
Regeneration Technologies, Inc. STERLING® Interference Screw ST 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K050767
Device Name:
STERLING® Interference Screw ST
Indications for Use:
The STERLING® Interference Screw ST is used to provide interference The STERENTO - and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft; fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.
Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
AND/OR
Over-The-Counter Use No
(21 CFR 801 Subpart C)
ON ANOTHER PAGE OF
NEEDED)
Kye Rhodes
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K050767