(63 days)
K/DEN number: Altra Modular Trauma System (Howmedica), Modular Nail (Richards), Uniflex Humeral Nail (Biomet), Polarus (Acumed)
Not Found
No
The device description focuses solely on the mechanical design and surgical application of an intramedullary rod for fracture fixation, with no mention of AI/ML capabilities or related data/performance metrics.
No
The device is an orthopedic implant for fixing fractures, which is a supportive and reconstructive function, not typically considered therapeutic in the sense of treating a disease or dysfunction organically.
No
Explanation: The device, an intramedullary nail, is used for fixation of fractures, which is a therapeutic purpose. It does not perform any diagnostic function such as identifying a disease or condition.
No
The device description clearly describes a physical implant (intramedullary rod, screws, etc.) used for fracture fixation, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Fixation of fractures of the proximal humerus." This describes a surgical procedure to stabilize a broken bone.
- Device Description: The description details a physical implant (an intramedullary rod) designed to be inserted into the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is an implant used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
Fixation of fractures of the proximal humerus. The device is a single use implant.
Product codes
HSB
Device Description
The Atlas Fracture Proximal Humeral Nail is a modular intramedullary rod. The proximal piece is a solid cylinder with multiple screw holes. Screw holes are placed in such a way to allow the surgeon options in reconstruction of the fracture fragments. Depending on the nature of the fracture, the humeral head, for example, may be fixed by a screw placed perpendicular to the nail, or an upward angle. If the tuberosities need to be reattached, holes placed 45 degree with respect to the holes used for head reattachment. Additionally, suture holes are provided for soft tissue reattachment.
The distal piece is a cylindrically shaped solid intramedullary stem tapered at the tip to conform to the natural humeral geometry. The stem is fluted to provide rotational stability at insertion. Longer stem lengths (
§ 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/0 description: The image shows the logo for Biomet INC. The logo is in black and white and features the company name in a stylized font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font.
K97 1816
Summary of Safety and Effectiveness Information
JUL 1 8 1997
Product: Atlas® Fracture Proximal Humeral Nail
Intended Use: Fixation of fractures of the proximal humerus. The device is a single use implant.
Device Description; The Atlas Fracture Proximal Humeral Nail is a modular intramedullary rod. The proximal piece is a solid cylinder with multiple screw holes. Screw holes are placed in such a way to allow the surgeon options in reconstruction of the fracture fragments. Depending on the nature of the fracture, the humeral head, for example, may be fixed by a screw placed perpendicular to the nail, or an upward angle. If the tuberosities need to be reattached, holes placed 45 degree with respect to the holes used for head reattachment. Additionally, suture holes are provided for soft tissue reattachment.
The distal piece is a cylindrically shaped solid intramedullary stem tapered at the tip to conform to the natural humeral geometry. The stem is fluted to provide rotational stability at insertion. Longer stem lengths (≤175mm) are available with three distal screw holes, in different planes, allow additional screw placement. Holes are sized larger than the screws to allow for clearance. Distal stems with screw holes are provided with a polyethylene plug friction fit into the screw holes. These are simply pushed out by the surgeon for the holes to be used. All lengths are available without screw holes. The proximal piece and distal stems attach by means of screw threads.
Potential Risks: The potential risks associated with this device are the same as with any other implantable device. These include, but are not limited to:
Blood Vessel Damage Bone Fracture Delayed Wound Healing Nerve Damage Metal Sensitivity Implant Fracture Cardiovascular Disorders
Infection Hematoma Non-Union or Delayed Union
Substantial Equivalent Devices: The Atlas Fracture Proximal Humeral Nail is substantially equivalent to other humeral nails on the market.
Altra Modular Trauma System (Howmedica) Modular Nail (Richards) Uniflex Humeral Nail (Biomet) Polarus (Acumed)
MAILING ADDRESS P.O. Box 58.' Warsaw, IN 46581-0587
SHIPPING ADDRESS Airport Industrial Park 1 -
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()FFICE = 219.267.66.39 .
FAX -FAX - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
E-MAII. E = = bionnet@biomet.com
1
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres `Director, Regulatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
JUL 1 8 1997
Re: K971816 Atlas® Fracture Proximal Humeral Nail Requlatory Class: II Product Code: HSB Dated: May 14, 1997 Received: May 16, 1997
Dear Ms. Beres:
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, 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 Requlations, 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 requlation (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 requlations.
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Page 2 - Ms. Patricia Sandborn Beres
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. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: _Atlas® Fracture_Proximal_Humeral_Nail
Fixation of fractures of the proximal humerus. The device Indications For Use: is a single use implant.
P colle
(Division Sign-Off) Division of General Restorative Devi 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF HEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
$\times$
Over-The-Counter Use_
(Optional Format 1-2-96)