(45 days)
No
The device description and performance studies focus on the mechanical properties of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for intramedullary knee arthrodesis, which is a surgical procedure to fuse a joint, thus providing a therapeutic effect.
No
A diagnostic device is used to identify a condition or disease. This device is an orthopedic implant for knee fusion, which is a treatment, not a diagnostic tool.
No
The device description explicitly states it is a "Knee Fusion Nail" made of Stainless Steel, which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for intramedullary knee arthrodesis." This describes a surgical procedure performed directly on the patient's body to fuse the knee joint.
- Device Description: The device is a "Knee Fusion Nail" inserted into the "medullary canal of long bones." This is a physical implant used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on these types of samples.
Therefore, the Knee Fusion Nail is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Product codes
JDS
Device Description
The Knee Fusion Nail is inserted in the medullary canal of long bones for knee arthrodesis. The Knee Fusion Nail features holes/slots on both ends of the nail for optional locking screws. The nails and screws are made of Stainless Steel. The screws were previously cleared in 510(k) K983942.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, medullary canal of long bones
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)
The Knee Fusion Nail was compared to predicate Intramedullary Knee Fusion Nails through an analysis of bending strength and flexural rigidity based on the cross-sectional geometry of the nail's shaft region and the material strength properties using hand calculations. The yield strength, ultimate bending strength and flexural rigidity of the subject Knee Fusion Nail were shown to be equivalent or superior to the predicate Knee Fusion Nails included in 510(k)s K893377 and K983942.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K061783 (pg 1 of 1)
510(k) Summary Knee Fusion Nail
Submitter's Name: Submitter's Address: Submitter's Telephone Number: Contact Person: Date Summary Prepared: Trade or Proprietary Device Name: Common or Usual Name: Classification Name:
Smith & Nephew, Inc., Orthopaedics 1450 Brooks Road, Memphis, TN 38116 901-399-6670 John Reabe June 22, 2006 Knee Fusion Nail Intramedullary Nail Intramedullary fixation rod 21 CFR 888.3020 Class II Orthopaedics/87/JDS
Device Description
Device Class:
Panel Code:
The Knee Fusion Nail is inserted in the medullary canal of long bones for knee arthrodesis. The Knee Fusion Nail features holes/slots on both ends of the nail for optional locking screws. The nails and screws are made of Stainless Steel. The screws were previously cleared in 510(k) K983942.
Intended Use
The Knee Fusion Nail is intended for intramedullary knee arthrodesis.
Device Comparison to Legally Marketed Devices
The Knee Fusion Nail is substantially equivalent to the Smith & Nephew Knee Fusion Nail included in 510(k) K050938 based on intended use and design features. The subject nail is Stainless Steel, similar to predicate nails in 510(k)s K893377 and K983942.
The Knee Fusion Nail is substantially equivalent to the Smith & Nephew Intramedullary Knee Fusion Nails included in 510(k)s K893377 and K983942 based on intended use and material.
The Knee Fusion Nail is substantially equivalent to the Smith & Nephew Titanium Nails included in 510(k) K981529 based on design features such as screw hole/slot configuration. The predicate nails are made of Titanium, available in shorter lengths and not intended for knee arthrodesis.
Performance Testing
The Knee Fusion Nail was compared to predicate Intramedullary Knee Fusion Nails through an analysis of bending strength and flexural rigidity based on the cross-sectional geometry of the nail's shaft region and the material strength properties using hand calculations. The yield strength, ultimate bending strength and flexural rigidity of the subject Knee Fusion Nail were shown to be equivalent or superior to the predicate Knee Fusion Nails included in 510(k)s K893377 and K983942.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract design of an eagle with three heads, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2006
Smith & Nephew, Inc. % Mr. John Reabe Director Regulatory Affairs Orthopaedics Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K061783
Trade/Device Name: Knee Fusion Nail Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDS Dated: June 23, 2006 Received: June 26, 2006
Dear Mr. Reabe:
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
2
Page 2 -- Mr. John Reabe
forth in the quality systems (OS) 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 (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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Валао впения
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): Ko6)783
Device Name: Knee Fusion Nail
Indications for Use:
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qabare Buchner for mym
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061783