(90 days)
The Titanium Retrograde Femoral Nail is indicated for internal fixation and stabilization of the femur. These devices are implanted by insertion into the medullary canal of the femur for fixation of open and closed acute distal femoral fractures, pathological fractures, malunions, nonunions, failed plate/screw osteosyntheses of the distal femur, fractures proximal to a total knee arthroplasty, fractures distal to a total hip prosthesis, and fixation of a surgically prepared femur (osteotomy) for correction of deformity.
Femoral nails are to be used for treatment of fractures of the femur including: non-I enoral natis and comminuted mid-shaft fracture, subtrochanteric fracture, distal third comminuted and commination mid bither fransal neck, intertrochanteric fracture, fracture, combination fractures of the mochanteric fractures. Other indications include: combination interactive procedures following tumor resection, and revision procedures where other treatments or devices have failed.
Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These 13 mm diameter nails have the same intended use, warnings and precautions as those nails previously cleared in K982953. A new 13 mm size is being added in 20cm, 24cm, 28cm, 32cm, 34cm, 36cm, 38cm, 40cm and 44cm lengths to expand the product line. The 13 mm diameter is larger than the retrograde style nails previously cleared.
This appears to be a 510(k) premarket notification for a medical device, specifically a Titanium Retrograde Femoral Nail. The provided documents describe the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way that would be relevant for a machine learning or diagnostic device.
The 510(k) pathway for traditional medical devices (like this intramedullary nail) typically relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new performance studies with acceptance criteria in the same manner as a novel diagnostic or AI device. The "Summary of Safety and Effectiveness" here focuses on the material, design similarity, and intended use compared to existing devices.
Therefore, many of the requested categories for acceptance criteria and study design are not applicable to the provided text. I will address each point based on the information available and note when information is not present or not relevant to this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative performance metrics for a novel study. | The device is substantially equivalent to Biomet Titanium Intramedullary Nails previously cleared in K982953. This implies performance is comparable to an already legally marketed device with a history of safe and effective use. The device is made of titanium alloy and is used for the same indications as stainless steel intramedullary rods that have been commercially available since the 1950s. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on substantial equivalence to a predicate device rather than a new clinical performance study with a test set. There is no new data provenance or sample size reported for the performance of this specific device model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth assessment by experts for a test set is not part of this 510(k) submission type. The "ground truth" for predicate devices is established through their long-standing use and clinical acceptance over decades.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described in this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical implant, not an AI or diagnostic device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the predicate devices, the "ground truth" for safety and effectiveness is implicitly established through decades of clinical use and physician experience with intramedullary rods for fracture fixation. No specific new ground truth for this device is established beyond its material and design similarity to existing devices. The submission states, "This device utilizes standard technology that is commonly known by physicians."
8. The sample size for the training set
Not applicable. This is a medical implant, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a medical implant, not a machine learning model.
Summary of Device and Approval Context:
The Titanium Retrograde Femoral Nail - 13 MM Diameter is an intramedullary rod used for internal fixation and stabilization of the femur in various fracture scenarios. The 510(k) clearance (K013923) was granted based on the device's substantial equivalence to previously cleared Biomet Titanium Intramedullary Nails (K982953), which themselves were equivalent to devices commercially available since the 1950s. This means the device met the regulatory requirements by demonstrating that its technology, intended use, and fundamental safety and effectiveness profiles are similar to devices already on the market. The FDA determined that no new premarket approval application (PMA) was required because the device does not raise new questions of safety and effectiveness.
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K013923 pg 1 OF 2
FEB 2 5 2002
Summary of Safety and Effectiveness
Applicant/Sponsor: Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
- Lonnie Witham Contact Person: Telephone: (219) 267-6639 Fax: (219) 372-1683
Proprietary Name: Titanium Retrograde Femoral Nail - 13 MM Diameter
Common Name: Titanium Intramedullary Nail (Rod)
Classification Name: Intramedullary Rods (21 CFR 888.3020)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed: These devices are substantially equivalent to Biomet Titanium Intramedullary Nails previously cleared in K982953.
-
Device Description: Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These 13 mm diameter nails have the same intended use, warnings and precautions as those nails previously cleared in K982953. A new 13 mm size is being added in 20cm, 24cm, 28cm, 32cm, 34cm, 36cm, 38cm, 40cm and 44cm lengths to expand the product line. The 13 mm diameter is larger than the retrograde style nails previously cleared. -
Intended Use: The Titanium Retrograde Femoral Nail is indicated for internal fixation and stabilization of the femur. These devices are implanted by insertion into the medullary canal of the femur for fixation of open and closed acute distal femoral fractures, pathological fractures, malunions, nonunions, failed plate/screw osteosyntheses of the distal femur, fractures proximal to a total knee arthroplasty, fractures distal to a total hip prosthesis, and fixation of a surgically prepared femur (osteotomy) for correction of deformity.
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K0R3923
ps 2 of 2
Summary of Technology: This device utilizes standard technology that is commonly known by physicians. This technology has been used in commercially available metallic internal fixation devices prior to May 28, 1976. This particular device is a tubular metal rod that is inserted into the medullary canal of the femur to stabilize bone fragments until healing has occurred.
All trademarks are property of Biomet, Inc.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lonnie Witham Biomet Orthopedics, Inc. P. O. Box 587 Warsaw. Indiana 46581
FEB 2 5 2002
Re: K013923
Trade/Device Name: Titanium Retrograde Femoral Nail - 13mm Diameter Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 21, 2001 Received: November 27, 2001
Dear Mr. Witham:
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Lonnie Witham
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Sincerely yours,
Mark N Millanin
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K013923
page 1 of 1
STATEMENT OF INDICATIONS FOR USE
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Device Name: Titanium Retrograde Femoral Nail - 13mm Diameter
Indications for Use:
Femoral nails are to be used for treatment of fractures of the femur including: non-I enoral natis and comminuted mid-shaft fracture, subtrochanteric fracture, distal third comminuted and commination mid bither fransal neck, intertrochanteric fracture, fracture, combination fractures of the mochanteric fractures. Other indications include: combination interactive procedures following tumor resection, and revision procedures where other treatments or devices have failed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K013923
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.