(77 days)
Not Found
No
The description focuses on the mechanical properties and dimensions of a physical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an interference screw used for graft fixation in ligament reconstruction, which is a surgical tool rather than a therapeutic device in the sense of delivering therapy.
No
Explanation: The RCI Fixation Screws are described as interference screws used for fixation of grafts in ligament reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical screw (rounded head interference screws with specific diameters and lengths) used for fixation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical fixation of grafts during surgical procedures (anterior or posterior cruciate ligament reconstruction). This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical screw used for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used outside the body to test samples like blood, urine, or tissue to provide information about a person's health. This device is implanted inside the body for structural support.
N/A
Intended Use / Indications for Use
RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
87HWC
Device Description
RCI Fixation Screws are rounded head interference screws which include diameters from 7 to 9 mm and a range of lengths from 25 mm to 50 mm. To allow for maximum amount of thread engagement, the thread profile is constant throughout the entire length of the screw. Except for direction of the threads, the Reverse Thread RCI screw is identical to the current RCI screw.
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
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)
RCI Fixation screws have been tested in the laboratory and found to have suitable fixation strength for use as interference screws.
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
MAY 20 1998
12 12
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is :
ર 980841
This summary was prepared on March 2,1998
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
Company Contact B.
Demetrios Tsakonas Clinical/Regulatory Specialist
C. Device Name
RCI Fixation Screws Proprietary Name:
Common Name: Screw, Fixation, Bone, Orthopedics
Screw: 87HWC Classification Name:
The Orthopedics Device Panel has classified Screw, Classification: Surgical as a Class II device. (21 CFR § 878.4930)
1
Predicate/Legally Marketed Devices D.
Arthrex Extra Long Screw (K915424): Arthrex 3050 NORTH HORSESHOE DRIVE SUITE 200 NAPLES, FL 33942
RCI Screw (K945687): Smith & Nephew Inc., Donjoy Division 2777 LOKER AVE. WEST CARLSBAD, CA 92008
E. Device Description
RCI Fixation Screws are rounded head interference screws which include diameters from 7 to 9 mm and a range of lengths from 25 mm to 50 mm. To allow for maximum amount of thread engagement, the thread profile is constant throughout the entire length of the screw. Except for direction of the threads, the Reverse Thread RCI screw is identical to the current RCI screw.
F. Performance
Bench Testing
RCI Fixation screws have been tested in the laboratory and found to have suitable fixation strength for use as interference screws.
G. Intended Use
RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.
2
Substantial Equivalenc H.
| Attribute | Current Product
RCI Fixation Screws | Substantially Equivalent Product
RCI Screw | Substantially Equivalent Product
Arthrex Extra Long Screw |
|---------------|-------------------------------------------|-----------------------------------------------|--------------------------------------------------------------|
| Indication | Graft Fixation for ACL/PCL Reconstruction | Graft Fixation for ACL Reconstruction | Graft Fixation for ACL/PCL Reconstruction |
| Dimensions | Length: .985" - 1.97" | Length: .985" | Length: 1.18" - 1.97" |
| | Major Diameter: .276" - .355" | Major Diameter: .276" - .355" | Major Diameter: .315" - .355" |
| Material | Titanium | Titanium | Titanium |
| Sterilization | Gamma Irradiation | Gamma Irradiation | NA |
| Labeling | Sterile/Non-Sterile | Sterile/Non-Sterile | NA |
Applicant
Signature
Date
3/28
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Smith and Nephew, Inc. 130 Forbes Boulevard 02048 Mansfield, Massachusetts
K980841 Re: Rounded Cannulated Inside-out (RCI) Trade Name: Fixation Screws Requlatory Class: II Product Code: HWC Dated: March 2, 1998 Received: March 4, 1998
Dear Mr. Tsakonas:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the read and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 – Mr. Demetrios Tsakonas
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510 (k) Number (If Known): K 9 80 84 1
Device Name: RCI Fixation Screws
Indications for Use:
RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcoello
(Division Sign-Off)
Division of General Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
or Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________