(40 days)
The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also indented to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.
The AOS Humeral Nail is a titanium humeral intramedullary nail that is design to enter the humerus through the greater tuberosity. It consists of an intramedullary nail, proximal and distal locking screws, compression screw and an end cap. The Humeral Nail is a cannulated nail with a 10° proximal bend and a proximal diameter of 10mm. The Humeral Nails are produced in 15cm, 20cm, 22cm, 24cm, 26cm and 28cm lengths and a distal diameters of 8mm. The proximal end of the nail has three holes to accept the 5 mm cancellous screw and one slot wich also accepts the 5.0mm cancellous screw. The Humeral Nail is produced in a left and a right configuration. The proximal end of the nail is threaded to accept an end cap. As medical judgment dictated addition angles, diameters and length may be added. The distal end of the nail contains two cross locking holes which are design to accept a 3,5mm cortical screw.
The provided text is a 510(k) summary for the AOS Humeral Nail, a medical device. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it argues for substantial equivalence to existing devices. Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from this document.
The document states: "Since the devices are substantial equivalent in design, geometry, construction and indications it was determine that no mechanical testing was necessary to demonstrate substantial equivalence." This indicates that no new performance studies, as you've described, were conducted for this 510(k) submission.
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510(k) SUMMARY
| NAME OF FIRM: | Advanced Orthopaedic Solutions |
|---|---|
| 510(k) CONTACT PERSON: | Gary Sohngen President |
| MAR 1 4 2005 | |
| TRADE NAME: | AOS Humeral Nail |
| COMMON NAME: | Intramedullary Fixation Rod |
| CLASSIFICATION: | 888.3020 Intramedullary Fixation Rod. |
| DEVICE CODE: | HSB |
SUBSTANTIALLY EQUIVALENT DEVICE:
INTENDED USE:
The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also indented to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The AOS Humeral Nail is a titanium humeral intramedullary nail that is design to enter the humerus through the greater tuberosity. It consists of an intramedullary nail, proximal and distal locking screws, compression screw and an end cap.
The Humeral Nail is a cannulated nail with a 10° proximal bend and a proximal diameter of 10mm. The Humeral Nails are produced in 15cm, 20cm, 22cm, 24cm, 26cm and 28cm lengths and a distal diameters of 8mm. The proximal end of the nail has three holes to accept the 5 mm cancellous screw and one slot wich also accepts the 5.0mm cancellous screw. The Humeral Nail is produced in a left and a right configuration. The proximal end of the nail is threaded to accept an end cap. As medical judgment dictated addition angles, diameters and length may be added.
The distal end of the nail contains two cross locking holes which are design to accept a 3,5mm cortical screw.
The AOS Humeral Nail was shown to be substantially equivalent to the following devices.
The AOS Humeral Nail was shown to be substantially equivalent in design, materials, intended use and size range to the devices listed below. Once assembled the geometry of the ASO nail and the predicate devices are virtually identical. Since the devices are substantial equivalent in design, geometry, construction and indications it was determine that no mechanical testing was necessary to demonstrate substantial equivalence.
AOS 510(k) Premarket Notification Humeral Nail
Confidential
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2005
Mr. Gary Sohngen President Advanced Orthopaedic Solution, Inc. 333 West 6th Street Suite 202 San Pedro, California 90717
Re: K050241
Trade/Device Name: AOS Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: January 2, 2005 Received: February 2, 2005
Dear Mr. Sohngen:
We have reviewed your Section 510(k) premarket notification of intent to market the adjoct we have reviewed your becaon 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Ciclosure) to regally manova province Amendments, or to commerce province to May 20, 1976, the enational with the provisions of the Federal Food, Drug, devices that have occh recatismed in accessfall of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Cosment Act (Act) that do not require approvince to the general controls provisions of the Act. The r ou may, dicrororo, maines of the Act include requirements for annual registration, listing of general controls provisions of practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device FFA it may be subject to saon aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Courselvests concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least be advised that i DFF of issualles or our device complies with other requirements of the Act that 1 DT has made a wond regulations administered by other Federal agencies. You must of any I coloral stututed and regarments, including, but not limited to: registration and listing (21 Comply with an the Her s requirements, we soll); good manufacturing practice requirements as set CI IT rat 607); adoling (21 CFR Part 820); and if applicable the electronic forth in the quality bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Gary Sohngen
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to ovegni maneting your and equivalence of your device to a legally premarket notification: "The PDs 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), please IT you desire specific advice for your as november 2010 . Also, please note the regulation entitled, Contact the Office of Comphanes at (21 t 7) = 1 = 7 = 7 = 7 = 7 = 7 = 7 = 7 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 Misofanding of Icrerchec to premarker notification of Sciffrom the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
L. Mark A. Millhazer
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: AOS Humeral Nail
Indications for Use:
The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the The AOS Humeral Nair is Intended to treat cases, four part humerus fractures. The numeral Nail is also indented to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.
AND/OR Prescription Use: X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use: (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millerson
and Ne
510(k) Number K050241
AOS 510(k) Premarket Notification Humeral Nail
Confidential
§ 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.