(49 days)
Synthes Titanium Unreamed Femoral Nail (Synthes), Alta® Femoral Nail (Howmedica)
Not Found
No
The device description focuses solely on the mechanical components and design of a femoral nail and associated screws, with no mention of software, algorithms, or data processing that would indicate AI/ML technology. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as an "interlocking intramedullary rod used in the fixation of fractures" for specific medical conditions and procedures, which addresses a pathological condition and restores function, fitting the definition of a therapeutic device.
No
The device description clearly states it is an "interlocking intramedullary rod used in the fixation of fractures of the nail." This indicates it is a therapeutic device (an implant for treatment), not a device used to diagnose a condition.
No
The device description clearly details a physical implant (intramedullary rod, screws, end caps) made of titanium alloy, which is hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device used for the surgical fixation of bone fractures and reconstructive procedures. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical implant (femoral nail, screws, end caps) designed to be surgically inserted into the body to stabilize bone. This is consistent with a medical device used for treatment, not for analyzing samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the Holland Titanium Femoral Nail is a surgical implant used for the treatment of bone fractures and related conditions, which falls under the category of a medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- fresh fractures of the femur to include; non-comminuted midshaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures. 2) osteotomy and reconstructive procedures following tumor resection. 3) revision procedures where other treatments or devices have failed. 4) arthrodesis.
This device is a single use implant.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Holland Titanium Femoral Nail is an interlocking intramedullary rod used in the fixation of fractures of the nail consists of four basic components, TI-Cannulated cancellous screws, TI-pilot threaded screws, Ticannulated end cap extensions, and the TI-femoral recon nail.
The nail is a solid titanium alloy component, available in both right and left configurations and one universal nail. Proximally the nail has an 8 degree offset enabling the surgeon to insert the nail through a more lateral insertion point -the greater trochanterand properly seat the nail within the femur.
The proximal end of the nail is a solid cylinder with three screw holes. The screw holes are arranged in a way to allow the surgeon options in reconstruction of the fracture fragments. The two most proximal screw holes are angled at 130 degrees from the diameter of the nail, are parallel and in line with one another. These interlocking screws improve fixation of fractures in the head and neck of the femur as well as increasing stability. The third hole from the proximal end is perpendicular to the diameter of the nail and allows for reattachment of the tuberosities if necessary.
The proximal end of the nail is slotted, allowing the surgeon to orient instrumentation.
The distal portion of the nail is solid and cylindrical in shape. Distally there are two interlocking screw holes. One of the holes is round allowing for a tight fit with respect to the screw, and the other is elongated to allow some flexibility for the screw placement desired by the surgeon.
There are different sizes of cannulated endcap extensions. The extensions are used to "cap" the proximal end of the nail thereby preventing ingrowth and allowing the surgeon greater access to the threaded end of the nail, by simply removing the endcap, if it would ever need to be removed.
There are two different screw types designed to be used with this nail. The first is the TIcannulated cancellous screw which is a titanium cannulated screw used in the proximal portion of the nail. There are several different sizes of the TI-cannulated cancellous screw (see component listing). The other type of screw used in conjunction with this nail is the TI-pilot threaded screws. These screws are designed to have a diameter of 4mm with a 6mm diameter for the holding threads giving this screw greater strength and not allowing it to migrate during healing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes Titanium Unreamed Femoral Nail (Synthes), Alta® Femoral Nail (Howmedica)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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4 1998 DEC
ﺔ ﺍﻟﻤﺘ
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet, Inc.
Airport Industrial Park
Warsaw, Indiana 46580 |
|----------------------|------------------------------------------------------------------|
| Device: | Holland Femoral Nail System |
| Classification Name: | Intramedullary fixation rod |
Intended Use: 1) fresh fractures of the femur to include; non-comminuted midshaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures. 2) osteotomy and reconstructive procedures following tumor resection. 3) revision procedures where other treatments or devices have failed. 4) arthrodesis.
This device is a single use implant.
Device Description: The Holland Titanium Femoral Nail is an interlocking intramedullary rod used in the fixation of fractures of the nail consists of four basic components, TI-Cannulated cancellous screws, TI-pilot threaded screws, Ticannulated end cap extensions, and the TI-femoral recon nail.
The nail is a solid titanium alloy component, available in both right and left configurations and one universal nail. Proximally the nail has an 8 degree offset enabling the surgeon to insert the nail through a more lateral insertion point -the greater trochanterand properly seat the nail within the femur.
The proximal end of the nail is a solid cylinder with three screw holes. The screw holes are arranged in a way to allow the surgeon options in reconstruction of the fracture fragments. The two most proximal screw holes are angled at 130 degrees from the diameter of the nail, are parallel and in line with one another. These interlocking screws improve fixation of fractures in the head and neck of the femur as well as increasing stability. The third hole from the proximal end is perpendicular to the diameter of the nail and allows for reattachment of the tuberosities if necessary.
The proximal end of the nail is slotted, allowing the surgeon to orient instrumentation.
The distal portion of the nail is solid and cylindrical in shape. Distally there are two interlocking screw holes. One of the holes is round allowing for a tight fit with respect to the screw, and the other is elongated to allow some flexibility for the screw placement desired by the surgeon.
There are different sizes of cannulated endcap extensions. The extensions are used to "cap" the proximal end of the nail thereby preventing ingrowth and allowing the surgeon
1
greater access to the threaded end of the nail, by simply removing the endcap, if it would ever need to be removed.
There are two different screw types designed to be used with this nail. The first is the TIcannulated cancellous screw which is a titanium cannulated screw used in the proximal portion of the nail. There are several different sizes of the TI-cannulated cancellous screw (see component listing). The other type of screw used in conjunction with this nail is the TI-pilot threaded screws. These screws are designed to have a diameter of 4mm with a 6mm diameter for the holding threads giving this screw greater strength and not allowing it to migrate during healing.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
-
- Nonunion or delayed union which may lead to breakage of the implant.
- Bending or fracture of the implant. Loosening and/or migration of the 2. implant.
-
- Metal sensitivity, or allergic reaction to a foreign body.
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- Limb shortening due to compression of the fracture or bone resorption.
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- Decrease in bone density due to compression of the fracture or bone resorption.
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- Pain, discomfort, or abnormal sensations due to the presence of the device.
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- Nerve damage due to surgical trauma.
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- Necrosis of bone.
Substantial Equivalence: In function and overall design Biomet's Holland Femoral Nail System is equivalent to most other intramedullary nails on the market.
Commercially available intramedullary femoral nails include:
Synthes Titanium Unreamed Femoral Nail (Synthes) Alta® Femoral Nail (Howmedica)
The intramedullary (IM) nails above and the Biomet Holland Nail are similar in both their intended use and the basic concept by which they are used.
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of a human figure embracing a globe. The emblem is positioned to the right of the text, which reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA' in a circular arrangement around the emblem. The text and emblem are both in black, set against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 4 1998
Mr. Fred McClure Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
K983641 Re : Holland Femoral Nail System Regulatory Class: II Product Code: HSB Dated: October 14, 1998 Received: October 16, 1998
Dear Mr. McClure:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 regulations.
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Page 2 - Mr. Fred McClure
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 leqally 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. Witten, Ph.D., M.D.
Director
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 (if known) : __________________________________________________________________________________________________________________________________________________
Device Name: Holland Femoral Nail System
- fresh fractures of the femur to include; non-comminuted midshaft fractures, Indications For Use: subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures. 2) osteotomy and reconstructive procedures following tumor resection. 3) revision procedures where other treatments or devices have failed. 4) arthrodesis.
This device is a single use implant.
Prescription Use . (Per 21 CFR 801.109)
Acobedo
(Division Sign-Off) Division of General Restorative Device 510(k) Number.
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