(49 days)
Not Found
Not Found
No
The summary describes a mechanical external fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for fracture treatment, reconstruction of extremities, limb lengthening, arthrodesis, and limb salvage, all of which are therapeutic interventions.
No
This device is an external fixation system used for limb salvage, fracture treatment, reconstruction, and limb lengthening. It is a therapeutic device, not a diagnostic one, as it does not diagnose medical conditions.
No
The device description clearly states it consists of physical components (CD rod, CD rod to rod connector) made of titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on the human body (limb salvage, fracture treatment, reconstruction, limb lengthening, arthrodesis, pelvic fractures). This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details components made of titanium alloy designed to be used in conjunction with external fixation systems. This aligns with a surgical implant/device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Alphatec External Fixation System does not fit this description.
N/A
Intended Use / Indications for Use
The complete Alphatec External Fixation System is indicated for limb salvage from traumatic injury; fracture treatment (i.e., long bone fracture, including the tibia, femur, humerus, radius, and ulnar bones); reconstruction of extremities with deformity and dysfunction; limb lengthening; arthrodesis; and pelvic fractures.
Product codes
KTT
Device Description
The Alphatec External Fixation System Compression/Distraction (CD) Rod consists of a CD rod that is available in two lengths and a CD rod to rod connector. These components are designed to be used in conjunction with the Alphatec External Fixation System and the Alphatec Wire External Fixation System which were the subject of prior premarket notifications. The additional use of the CD rod with the systems listed adds the capabilities of limb lengthening during fracture fixation.
The CD rod and CD rod to rod connector are manufactured from titanium alloy (Ti-6Al-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb, long bone (tibia, femur, humerus, radius, ulnar bones), extremities, pelvic
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)
Howmedica Hoffmann II External Fixation System, Ace Unifix External Fixation System, Smith & Nephew Ilizarov External Fixator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a logo for a company called "ALPHATEC Manufacturing, Inc." The logo consists of a circular emblem with the Greek letter alpha inside, followed by the company name in bold, block letters. The text is stacked, with "ALPHATEC" on top and "Manufacturing, Inc." below it. The image is black and white.
Premarket Notification
Alphatec External Fixation System
Compression/Distraction Rod
Alphatec Manufacturing, Inc.
510(k) Summary
510(k) Number
K99 3873
Manufacturer Identification
Alphatec Manufacturing, Inc. Submitted By: 42-160 State Street Palm Desert, CA 92211 phone: (760) 779-8250 (760) 779-8257 fax: Contact Person: Jason Blain Manager of Product Development November 12, 1999 Date Summary Prepared: Device Identification Alphatec External Fixation System Proprietary Name: Compression/Distraction Rod Common Name: External Fixation System 21 CFR 888.3030: Appliance, Fixation, Nail/Blade/Plate Classification: Combination, Multiple Component
Device Description
The Alphatec External Fixation System Compression/Distraction (CD) Rod consists of a CD rod that is available in two lengths and a CD rod to rod connector. These components are designed to be used in conjunction with the Alphatec External Fixation System and the Alphatec Wire External Fixation System which were the subject of prior premarket notifications. The additional use of the CD rod with the systems listed adds the capabilities of limb lengthening during fracture fixation.
The CD rod and CD rod to rod connector are manufactured from titanium alloy (Ti-6Al-4V).
Intended Use of the Device
The complete Alphatec External Fixation System is indicated for limb salvage from traumatic injury; fracture treatment (i.e., long bone fracture, including the tibia, femur, humerus, radius, and ulnar bones); reconstruction of extremities with deformity and dysfunction; limb lengthening; arthrodesis; and pelvic fractures.
1
Image /page/1/Picture/1 description: The image shows the logo for AlphaTec Manufacturing, Inc. The logo consists of a black circle with a white alpha symbol inside. Below the circle, the word "ALPHATEC" is written in a bold, sans-serif font. Underneath "ALPHATEC", the words "Manufacturing, Inc." are written in a smaller, less bold font.
Premarket Notification lphatec External Fixation System Compression/Distraction Rod Alphatec Manufacturing, Inc.
Substantial Equivalence
The Alphatec External Fixation System with the addition of the CD rod is substantially equivalent to the Howmedica Hoffmann II External Fixation System, Ace Unifix External Fixation System, and the Smith & Nephew Ilizarov External Fixator. The Alphatec External Fixation System is similar to each of the listed predicate devices in one or more of the following areas: design, function, materials used, and indications for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling an abstract human figure.
Public Health Service
JAN - 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jason Blain Manager of Product Development Alphatec Manufacturing, Inc. 42-160 State Street Palm Desert, California 92211-5148
Re: K993873
Trade Name: Alphatec External Fixation System Compression/Distraction Rod Regulatory Class: II Product Code: KTT Dated: November 12, 1999 Received: November 15, 1999
Dear Mr. Blain:
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 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.
3
Page 2 - Mr. Jason Blain
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) 594-4595. 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 vours,
J. H. C. Meyer
800
- James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo and text for Alphatec Manufacturing, Inc. The logo is on the left side of the image and consists of a circle with the letters 'O' and 'a' inside, followed by the word 'ALPHATEC'. To the right of the logo, the text reads 'Premarket Notification', 'Alphatec External Fixation System', 'Compression/Distraction Rod', and 'Alphatec Manufacturing, Inc.'.
Intended Uses/Indications
K993873 510(k) Number:
Device Name: Alphatec External Fixation System
Indications for Use:
The Alphatec External Fixation System is indicated for limb salvage from traumatic injury; fracture treatment (i.e., long bone fracture, including the tibia, femur, humerus, radius, and ulnar bones); reconstruction of extremities with deformity and dysfunction; limb lengthening; arthrodesis; and pelvic fractures.
Prescription Use
(Per 21 CFR 801.109)
Thurrell Layton
on Sion-Off) of General Restorative Devices 510(k) Number K 25 38 22