(58 days)
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 into the long bones for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.
Intramedullary rods are generally rod-shaped devices with or without screw holes at either end for fixation to bone. These devices are intended to be inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures by aligning and stabilizing the bone fragments. Intramedullary rods are also used to align and stabilize long bones which are surgically cut (osteotomy) to correct deformity. Additional stabilization may be realized by installing transverse screws through holes in the rod. Intramedullary rods and transverse screws are made of titanium 6Al-4V alloy.
This document is a 510(k) premarket notification for a medical device: Titanium Intramedullary Rods - Various Styles by Biomet, Inc.
Based on the provided text, the device is considered substantially equivalent to existing, legally marketed stainless steel intramedullary rods. This means that a specific study to prove new acceptance criteria for the titanium rods was likely not performed in the same way a new, novel device would be. Instead, the focus is on demonstrating that the new device (titanium) has the same function and overall design as a predicate device (stainless steel) that has a long history of safe and effective use.
Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present in this type of submission. However, I can infer and answer based on the nature of a 510(k) submission for substantial equivalence.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The provided summary does not outline specific numerical 'acceptance criteria' in the way a new device with novel performance claims would. For a 510(k) submission based on substantial equivalence, the primary "acceptance criterion" is that the device is as safe and effective as a legally marketed predicate device. The "reported device performance" is implicitly established by its equivalence to the predicate.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (as presented in the 510(k)) |
|---|---|
| Safety and Effectiveness | "In function and overall design, titanium intramedullary rods are equivalent to stainless steel intramedullary rods which have been widely used for fracture fixation in long bones since the 1960s." This statement directly asserts that the device meets the safety and effectiveness profile equivalent to established predicate devices. The discussion of potential risks (delayed/nonunion, bending/fracture, loosening/migration, metal sensitivity, limb shortening, pain, nerve damage, necrosis, infection, hematoma) acknowledges known risks common to any metallic internal fixation device, implying the titanium device shares these known risks and is not introducing new or more severe ones compared to the predicate. |
| Biocompatibility (Implicit for medical implants) | The device is made of titanium 6Al-4V alloy. This material is well-established and widely used in medical implants, suggesting its biocompatibility is accepted and not a new challenge. The mention of "metal sensitivity, or allergic reaction to a foreign body" is a general potential risk, not specific to titanium over stainless steel as a new problem. |
| Mechanical Performance (Implicit, e.g., strength, durability) | The statement "In function and overall design, titanium intramedullary rods are equivalent to stainless steel intramedullary rods" implies that the mechanical properties (strength, resistance to bending/fracture) are comparable and suitable for their intended use. The potential risks like "Bending or fracture of the implant" are acknowledged as general risks for any such device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There is no explicit test set or sample size described for a study conducted on the Biomet Titanium Intramedullary Rods to prove acceptance criteria. This is typical for a 510(k) based on substantial equivalence to a predicate device with a long history of use. The "data provenance" for the predicate device's performance is its history of use since the 1960s, implying real-world, clinical data collected over decades, likely from various countries where it was used. This is generally retrospective and observational.
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. No specific "test set" and corresponding "ground truth" establishment by experts for the new device's performance is described in this 510(k) summary. The ground truth for the predicate device's safety and effectiveness is established through decades of widespread clinical use and acceptance by the medical community.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As there is no explicit test set or specific performance study described for the titanium rods, no adjudication method would have been used.
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 device is a physical implant (intramedullary rod), not a diagnostic imaging device or an AI application that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's acceptable performance and safety profile is effectively the long-term clinical outcomes data and expert consensus derived from the widespread and historical use of the predicate stainless steel intramedullary rods since the 1960s. The 510(k) argues that the titanium version functions the same way and is made of a known, safe material, hence it inherits this "ground truth" of established safety and effectiveness.
8. The sample size for the training set
Not applicable. This device is a physical implant, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this type of device submission.
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K982953 10f2
OCT 2 | 1998
Image /page/0/Picture/2 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font. The logo is simple and professional, and it conveys a sense of stability and reliability.
Summary of Safety and Effectiveness
Sponsor. Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581
Device. Titanium Intramedullary Rods - Various Styles
Classification Name. Rod, Fixation, Intramedullary and Accessories (CFR 888.3020)
Device Description. Intramedullary rods are generally rod-shaped devices with or without screw holes at either end for fixation to bone. These devices are intended to be inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures by aligning and stabilizing the bone fragments. Intramedullary rods are also used to align and stabilize long bones which are surgically cut (osteotomy) to correct deformity. Additional stabilization may be realized by installing transverse screws through holes in the rod. Intramedullary rods and transverse screws are made of titanium 6Al-4V alloy.
Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.
Potential Risks. The risks associated with this device are the same as with any metallic internal fixation device. These include but are not limited to the following.
Delayed or nonunion which may lead to breakage of the implant
Bending or fracture of the implant
Loosening or migration of the implant
Metal sensitivity, or allergic reaction to a foreign body
Limb shortening or decrease in bone density due to compression of the fracture or bone resorption
Pain, discomfort, or abnormal sensations due to the presence of the device
MAILING ADDRESS PO Box 587 - P.O. Box 587
Warsaw, IN 46581-0587 - - - -
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
행
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.cor000093
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Kag, 2453 20f2
Nerve damage due to surgical trauma
Necrosis of bone
Infection
((
Hematoma
Substantial Equivalence. In function and overall design, titanium intramedullary rods are equivalent to stainless steel intramedullary rods which have been widely used for fracture fixation in long bones since the 1960s.
. . . . . . . . .
Grosse Kempf System (Howmedica) Intramedullary Nails (Zimmer) Kirschner Intramedullary Nail System (now Biomet, Inc.) OEC Kuntscher Cloverleaf Nail Systems (now Biomet, Inc.)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side, and a stylized emblem on the right. The emblem features a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Mr. Lonnie Witham 6enior Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K982953 Titanium Intramedullary Nails - Various Styles Regulatory Class: II Product Code: HSB Dated: August 18, 1998 Received: August 24, 1998
Dear Mr. Witham:
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 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 (Premarket Approval), 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 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 General regulation (21 CFR Part 820) and that, Devices: 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 requlations.
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Page 2 - Mr. Lonnie Witham
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,
Celia M. Whitton, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K982953
Device Name: Titanium Intramedullary Nails
Indications For Use: 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 into the long bones for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur, tibia, fibula, humerus, radius, and ulna.
(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) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K982953 |
|---|---|
| --------------- | --------- |
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§ 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.