(72 days)
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Not Found
No
The device description focuses on the mechanical properties and design of a metal rod and screws for ankle fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for arthrodesis (fusion) of the ankle joint, which is a medical procedure to treat a condition and restore function.
No
Explanation: The device is an ankle fusion rod system, which is an implant used for arthrodesis (fusion) of the ankle joint, not for diagnosing a condition.
No
The device description clearly details physical components made of titanium, including rods, screws, and a guide wire, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for arthrodesis of the ankle joint." This is a surgical procedure performed in vivo (within the living body) to fuse bones.
- Device Description: The device is a physical implant (an ankle fusion rod system) made of titanium, designed to be surgically inserted into the ankle joint.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is a surgical implant used for structural support and fusion.
N/A
Intended Use / Indications for Use
The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.
Product codes
HSB
Device Description
All components of the UltiMax Ankle Fusion Rod System are manufactured from titanium (6A1-4V ELI) per ASTM F136.
The rod geometry features sharp flutes to obtain initial stability. The rod is bi-diameter to maximize strength in the distal region, tapering down 2mm to accommodate the tibial intramedullary canal. The rod is locked with one or two 5mm transfixing screws in the tibia proximally and are screwed distally in the calcaneous. Rods range in lengths from 150mm == 325mm (25mm increments) and diameters of 11mm and 13mm. Transfixing cortical screws are available in lengths ranging from 60-100mm in 2mm increments.
The rod also features a unique "compression slot" allowing up to 25mm of static or dynamic compression at the ankle joint. This is achieved with compression screws through the distal cannulation being driven against a distal transfixing screw. The compression screws are available in 12mm, 22mm, and 32mm lengths. The rod is fully cannulated for use with a small 2mm guide wire. The small cannulation maintains optimal strength while allowing traditional techniques for rodding.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ankle joint, tibia, calcaneous
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Testing was performed on the UltiMax Ankle Fusion System. Test results proved the device to be of sound design.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
K991790
Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: UltiMax Ankle Fusion Rod System
Common Name: Ankle Fusion Rod
Classification Name: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030
Device Description: All components of the UltiMax Ankle Fusion Rod System are manufactured from titanium (6A1-4V ELI) per ASTM F136.
The rod geometry features sharp flutes to obtain initial stability. The rod is bi-diameter to maximize strength in the distal region, tapering down 2mm to accommodate the tibial intramedullary canal. The rod is locked with one or two 5mm transfixing screws in the tibia proximally and are screwed distally in the calcaneous. Rods range in lengths from 150mm == 325mm (25mm increments) and diameters of 11mm and 13mm. Transfixing cortical screws are available in lengths ranging from 60-100mm in 2mm increments.
The rod also features a unique "compression slot" allowing up to 25mm of static or dynamic compression at the ankle joint. This is achieved with compression screws through the distal cannulation being driven against a distal transfixing screw. The compression screws are available in 12mm, 22mm, and 32mm lengths. The rod is fully cannulated for use with a small 2mm guide wire. The small cannulation maintains optimal strength while allowing traditional techniques for rodding.
Intended Use: The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.
Comparable Features to Predicate Device(s): Based on the intended uses, design, testing, and manufacturing, the UltiMax Ankle Fusion Rod System is equivalent to the referenced legally marketed comparison devices.
Test Results: Testing was performed on the UltiMax Ankle Fusion System. Test results proved the device to be of sound design.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 1999
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758
Re: K991790
Trade Name: Ultimax Ankle Fusion Rod System Regulatory Class: II Product Code: HSB Dated: May 24, 1999 Received: May 26, 1999
Dear Ms. De Los Santos:
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 control provisions of the Act. The general control 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 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 action. In addition, FDA may publish further announcements 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.
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.
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Page 2 – Ms. Debbie De Los Santos
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia 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 (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
UltiMax Ankle Fusion Rod Indications For Use
The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.
(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)_
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(Division Sign-Off) Division of General Restorative Devices 12991790 510(k) Number