(20 days)
No
The device description and performance studies focus on the mechanical properties and design of a traditional intramedullary nail, with no mention of AI or ML technologies.
No
Explanation: This device is for intramedullary knee arthrodesis, which is a surgical procedure to fuse the knee joint. While it aids in a medical treatment, it's a structural implant, not an active device that delivers therapy or affects the body through non-mechanical means. Therapeutic devices typically involve modalities like electrical stimulation, heat, light, or drug delivery.
No
Explanation: The device, a Knee Fusion Nail, is used for intramedullary knee arthrodesis, which is a surgical procedure to fuse bones. It is an implant used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical implant (Knee Fusion Nail) made of titanium alloy with corresponding screws, intended for surgical insertion. This 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Knee Fusion Nail is an implantable device inserted into the medullary canal of long bones for knee arthrodesis (surgical fusion of the knee joint). This is a surgical procedure performed directly on the patient's body.
- Intended Use: The intended use is for "intramedullary knee arthrodesis," which is a surgical treatment, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
Knee Fusion Nails are for intramedullary knee arthrodesis.
Product codes
JDS
Device Description
A Knee Fusion Nail is inserted into the medullary canal of long bones for knee arthrodesis. The design of the Knee Fusion Nail is based on Smith & Nephew's (formally Richards Medical) experience with intramedullary nail systems, which dates back to the 1950's. The Knee Fusion Nail includes intramedullary interlocking nails with corresponding screws. The Knee Fusion Nail and corresponding screws are made of Ti-6Al-4V titanium alloy with holes/slots for optional locking screws on both ends of the nail. Locking screws are available for optional and distal locking. Screws are available in 5.0mm, and 6.4mm diameters with varying lengths. The screws were previously cleared in 510(k) K981529. The device is intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medullary canal of long bones for knee arthrodesis
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)
A review of the four point bend fatigue test indicated that the Knee Fusion Nail is equivalent to devices currently used clinically.
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
§ 888.3030 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
Image /page/0/Picture/2 description: The image shows a logo with the words "+ MANSERVICES" at the top and "DEPART. OF" on the left side. The logo also features a stylized graphic of three curved lines that resemble a bird in flight or a wave pattern. The text and graphic are arranged in a circular fashion.
MAY 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laurie Jordan Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re: K050938 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: April 01,2005 Received: April 14,2005
Dear Ms. Jordan:
This letter corrects our substantially equivalent letter dated May 04,2005 regarding the incorrect Regulation Number and Regulation Name. The May 04, 2005 letter listed 888.3020 as the Regulation Number and Intramedullary Rod as the Regulation Name.
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 (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 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.
1
Page 2 - Ms. Laurie Jordan
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 (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 continue 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Stypt Rhodes
Miriam Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| prescription Use | X |
|---|---|
| (Per21 CFR 801.109) |
OR
| Over-the-counter Use | |
|---|---|
| (Optional Format 1-2-96) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K050938 |
|---|---|
| --------------- | --------- |
3
050938
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: DEVICE CLASSIFICATION: DEVICE CLASS: PANEL CODE:
Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-5042 Laurie Jordan April 1, 2005 Knee Fusion Nail Intramedullary Nail 21 CFR 888.3020, Intrameduliary Fixation Rod Class II Orthopedic/87
DEVICE INFORMATION:
INTENDED USE:
Knee Fusion Nails are for intramedullary knee arthrodesis.
DEVICE DESCRIPTION:
A Knee Fusion Nail is inserted into the medullary canal of long bones for knee arthrodesis. The design of the Knee Fusion Nail is based on Smith & Nephew's (formally Richards Medical) experience with intramedullary nail systems, which dates back to the 1950's. The Knee Fusion Nail includes intramedullary interlocking nails with corresponding screws. The Knee Fusion Nail and corresponding screws are made of Ti-6Al-4V titanium alloy with holes/slots for optional locking screws on both ends of the nail. Locking screws are available for optional and distal locking. Screws are available in 5.0mm, and 6.4mm diameters with varying lengths. The screws were previously cleared in 510(k) K981529. The device is intended for single use.
MECHANICAL AND CLINICAL DATA
A review of the four point bend fatigue test indicated that the Knee Fusion Nail is equivalent to devices currently used clinically.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The substantial equivalence of the Knee Fusion Nail is based on its similarities in indications for use, design features, and operational principles to the Russell-Taylor Intramedullary Knee Fusion Nail (K893377 and K983942). Both of these devices are inserted into the medullary canal of long bones for knee arthrodesis. Each one of these devices has holes/slots for optional locking screws on the proximal and distal ends. The difference between the Knee Fusion Nail and these predicate devices are that the predicate devices are made of ASTM F 138 and ISO 5832/1 stainless steel and the Knee Fusion Nail is made of Ti-6Al-4V Titanium Alloy. The differences between the Knee Fusion Nail and these predicate devices do not affect safety and effectiveness.
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