(78 days)
Not Found
No
The 510(k) summary describes a purely mechanical device (fixation screws) and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The RCI Fixation Screws are used for mechanical fixation of grafts in ligament reconstruction, which is a structural and reparative function rather than a therapeutic one (e.g., drug delivery, energy application, or physiological modulation).
No
The device, RCI Fixation Screws, is an orthopedic implant used for interference fixation of grafts in ligament reconstruction, which is a therapeutic function, not a diagnostic one. It does not analyze patient data or provide information for diagnosis.
No
The device description clearly states it is a physical screw used for surgical fixation, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that RCI Fixation Screws are used for interference fixation of grafts in ligament reconstruction. This is a surgical procedure performed directly on the patient's body, not on a specimen taken from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
The RCI Fixation Screw is a surgical implant used to physically secure tissue within the body.
N/A
Intended Use / Indications for Use
RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.
Product codes
HWC
Device Description
RCI Fixation Screws are rounded head interference screws, which include diameters from 6 to 12 mm and a range of lengths from 25 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 Fixation 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)
Bench Testing
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)
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
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. 1 018
The assigned 510(k) number is :
This summary was prepared on August 27, 1999.
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
Company Contact B.
Nicholas Condakes Regulatory Affairs Specialist
C. Device Name
| Proprietary Name: | RCI Fixation Screws |
|---|---|
| Common Name: | Screw, Fixation, Bone, Orthopedics |
| Classification Name: | Screw: 87HWC |
| Classification: | The Orthopedics Device Panel has classified Screw Surgical as a Class II device. (21 CFR § 888.3040) |
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Predicate/Legally Marketed Devices D.
RCI Fixation Screw (K980841): Smith + Nephew Inc., Endoscopy Division 130 FORBES BLVD MANSFIELD, MA 02048
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KG92945
E. Device Description
RCI Fixation Screws are rounded head interference screws, which include diameters from 6 to 12 mm and a range of lengths from 25 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 Fixation 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-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.
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30/3
H. Substantial Equivalence
| Attribute
| ↓ | Current Product | Substantially Equivalent Product |
|---|---|---|
| Indication | Graft Fixation for ACL/PCL | |
| Reconstruction | Graft Fixation for ACL/PCL | |
| Reconstruction | ||
| Dimensions | Length: .985" - 1.97" | Length: .985" - 1.97" |
| Major Diameter: .236" - .474" | Major Diameter: .276" - .355" | |
| Material | Titanium | Titanium |
| Sterilization | Gamma Irradiation | Gamma Irradiation |
| Labeling | Sterile/Non-Sterile | Sterile/Non-Sterile |
| RCI Fixation Screws | RCI Fixation Screws | |
| K980841 |
Applicant Nicholas Cordukes
Date 8/31/99
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1999
Mr. Nicholas Condakes Regulatory Affairs Specialist Smith & Nephew, Inc. 130 Forbes Boulevard 02048 Mansfield, Massachusetts
K992945 Re: RCI Fixation Screws Trade Name: Requlatory Class: II Product Code: HWC Dated: August 31, 1999 Received: September 1, 1999
Dear Mr. Condakes:
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 requlations affecting your device can be found in the Code of Federal Regulations, 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 Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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.
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Page 2 - Mr. Nicholas Condakes
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,
Verner L. Sayer
for James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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11-992945 510 (k) Number (If Known):
Device Name: RCI Fixation Screws
Indications for Use:
RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue 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)
Russell F. Ryan
(Division Sign-Off) J22 Division of General Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
or Over-The-Counter Use