(45 days)
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Knee Fusion Nail, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| Bending Strength | Equivalent or superior to predicate Knee Fusion Nails (K893377 and K983942) |
| Flexural Rigidity | Equivalent or superior to predicate Knee Fusion Nails (K893377 and K983942) |
| Yield Strength | Equivalent or superior to predicate Knee Fusion Nails (K893377 and K983942) |
2. Sample Size Used for the Test Set and Data Provenance
The review states "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." This implies a theoretical analysis based on design specifications and material properties rather than a test performed on a sample set of physical devices. Therefore, a traditional "sample size" for a test set and associated data provenance (country of origin, retrospective/prospective) are not applicable to this type of analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" was established through engineering calculations and material property comparisons.
- Qualifications of Experts: Not applicable. The analysis was based on engineering principles and material science, not expert consensus on observations.
4. Adjudication Method for the Test Set
Not applicable, as there was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission describes a device (Knee Fusion Nail) which is a physical implant, not a diagnostic or assistive technology that would be used by human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. The "device" in question is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was established using engineering principles, material strength properties, and design specifications (cross-sectional geometry of the nail's shaft region). The performance of the subject device was then compared against these established properties for predicate devices.
8. The Sample Size for the Training Set
Not applicable. The submission describes a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set.
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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.
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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
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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
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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
§ 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.