(70 days)
Not Found
Not Found
No
The description focuses on the mechanical components and materials of an intramedullary nail system, with no mention of AI or ML capabilities.
Yes
The device is an intramedullary nail system used for internal fixation of bone fractures, which is a therapeutic intervention aimed at treating injuries.
No
The device is an intramedullary nail system used for internal fixation of bone fractures, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines physical components made of titanium alloy (intramedullary rods, screws, end cap), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the Pylon Intramedullary Nail System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the internal fixation of bone fractures in the tibia or femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details physical implants (rods, screws, end caps) made of titanium alloy, designed to be inserted into the bone canal.
- 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Pylon Intramedullary Nail System is an in vivo (inside the body) device used for surgical treatment.
N/A
Intended Use / Indications for Use
The Pylon Intramedullary Nail System is indicated for internal fixation of tibial or femoral fractures including low subtrochanteric fractures, transverse fractures, oblique and spiral fractures, segmental fractures, comminuted fractures, high supracondylar fractures, fractures with bone loss, stabilization for bone transport or lengthening and shortening, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the bone shaft, nonunions, malunions, metaphyseal junction fractures, and acute bone lengthening and shortening.
Product codes
HSB
Device Description
The Pylon Intramedullary Nail System consists of intramedullary rods and screws for fixation inside the canal of the tibia or femur. The rods are cylindrically shaped and either made of a solid or cannulated construct, depending on the outer diameter of the rod. Rods are available in a variety of diameters and lengths and have holes located in the proximal and distal ends for fixation to bone by means of bone screws. Bone screws are also available in a multitude of diameters and lengths. An end cap is available that screws into the proximal end of the nails to prevent bone ingrowth which may hamper the attachment of extraction instrumentation. All components of the Pylon Intramedullary Nail System 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
tibial or femoral fractures
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)
ACE AIM Titanium Nails (Depuy ACE, a Johnson and Johnson company)
Reference Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows a logo for a company called "ALPHATEC Manufacturing, Inc." The logo consists of a circle with the Greek letter alpha inside it. Below the circle, the company name is printed in a bold, sans-serif font. The text is black and the background is white.
Premarket Notification slon Intramedullary Nail System Iphatec Manufacturing, Inc.
510(k) Summary
510(k) Number
510(k) Number K992350
Manufacturer Identification
| Submitted By: | Alphatec Manufacturing, Inc.
42-160 State Street
Palm Desert, CA 92211
phone: (760) 779-8250
fax: (760) 776-5527 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Blain
Manager of Product Development |
| Date Summary Prepared: | July 12, 1999 |
| Device Identification | |
| Proprietary Name: | Pylon Intramedullary Nail System |
| Common Name: | Intramedullary Fixation System |
| Classification: | 21 CFR 888.3020: Rod, Fixation, Intramedullary and Accessories |
Device Description
The Pylon Intramedullary Nail System consists of intramedullary rods and screws for fixation inside the canal of the tibia or femur. The rods are cylindrically shaped and either made of a solid or cannulated construct, depending on the outer diameter of the rod. Rods are available in a variety of diameters and lengths and have holes located in the proximal and distal ends for fixation to bone by means of bone screws. Bone screws are also available in a multitude of diameters and lengths. An end cap is available that screws into the proximal end of the nails to prevent bone ingrowth which may hamper the attachment of extraction instrumentation.
All components of the Pylon Intramedullary Nail System are manufactured from titanium alloy (Ti-6Al-4V).
Intended Use of the Device
The Pylon Intramedullary Nail System is indicated for internal fixation of tibial or femoral fractures including low subtrochanteric fractures, transverse fractures, oblique and spiral fractures, segmental fractures, comminuted fractures, high supracondylar fractures, fractures with bone loss, stabilization for bone transport or lengthening and
1
Image /page/1/Picture/0 description: The image shows a logo for a company called ALPHATEC Manufacturing, Inc. The logo features a circular emblem with a stylized "O" in the center, possibly representing the company's initial or a symbol of quality. Below the emblem, the company name "ALPHATEC Manufacturing, Inc." is printed in a bold, sans-serif font, emphasizing the company's focus on manufacturing.
20F2
shortening, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the bone shaft, nonunions, malunions, metaphyseal junction fractures, and acute bone lengthening and shortening.
Substantial Equivalence
The Pylon Intramedullary Nail System is substantially equivalent to ACE AIM Titanium Nails (Depuy ACE, a Johnson and Johnson company). The Pylon Intramedullary Nail System is similar to the listed predicate device in design, function, materials used, and indications for use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes extending from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1999
Mr. Jason Blain Manager of Product Development Alphatec Manufacturing, Inc. 42-160 State Street Palm Desert, California 92211
Re: K992350 Trade Name: Pylon Intramedullary Nail System Regulatory Class: II Product Code: HSB Dated: July 12, 1999 Received: July 14, 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 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.
3
Page 2 - Mr. Jason Blain
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,
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
4
Image /page/4/Picture/0 description: The image shows a logo for a company called "ALPHATEC Manufacturing, Inc." The logo consists of a circular emblem with the letters "OA" inside. Below the emblem, the company name is written in a bold, sans-serif font. The word "ALPHATEC" is on the first line, and "Manufacturing, Inc." is on the second line in a smaller font size.
Premarket Notification Pylon Intramedullary Nail System Alphatec Manufacturing, Inc.
Intended Uses/Indications
K9923350 510(k) Number:
Device Name: Pylon Intramedullary Nail System
Indications for Use:
The Pylon Intramedullary Nail System is indicated for internal fixation of tibial or femoral fractures including low subtrochanteric fractures, transverse fractures, oblique and spiral fractures, segmental fractures, comminuted fractures, high supracondylar and spiral fractures with bone loss, stabilization for bone transport or lengthening and shortening, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the bone shaft, nonunions, malunions, metaphyseal/diaphyseal junction fractures, and acute bone lengthening and shortening.
bodles
(Division Sigh, Off) · · sion of General Re 5 | Ü(K) Number
455
Prescription Use
(Per 21 CFR 801.109)