(64 days)
K011815, K04186
No
The device description focuses solely on the physical characteristics and materials of a bone plate and screws, with no mention of software, algorithms, or data processing.
Yes
The device is used to fix fractures and osteotomies, which are medical treatments for conditions, thus qualifying it as therapeutic.
No
This device is an internal fixation device used for treating fractures of the humerus, not for diagnosing medical conditions.
No
The device description clearly details a physical implantable plate and screws made of titanium alloy, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The AOS Proximal Humeral Plate is an implantable surgical device used for fixing bone fractures. It is physically placed inside the body to stabilize the bone.
- Intended Use: The intended use is to treat fractures, dislocations, osteotomies, and non-unions of the proximal humerus. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a device used for internal fixation of bone, which falls under the category of surgical implants, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AOS Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Product codes
KTW
Device Description
The AOS Proximal Humeral Plate is an internal fixation device for the fixation of fractures of the humeral head and is intended as a load sharing device which may be removed once the fracture has healed.
The plate is manufactured in multiple lengths with the overall length of the plate ranging from 97mm to 236mm. The proximal portion has eight 135° angled holes to accept 4.0mm locking screw. The distal portion has 3, 5, 8, 11 and 14 hole configurations which will accept a 4.0mm locking screw or a 3.5mm cortical screw. There are three associated screws for the AOS Proximal Humeral Plate; the 4.0mm fully threaded locking screws, the 4.0mm partially threaded locking screw and the 3.5mm cortical screw. The AOS Proximal Humeral Plates and screws are manufactured from tifanium alloy.
The overall length of the AOS Proximal Humeral Plate ranges from 97mm to 236mm while the proximal portion is consistent for all plates at 48mm. The proximal portion of the plate contains 8 threaded holes that accept the 4.0mm partially threaded cancellous locking screw. The proximal portion of the plate also contains six suture holes and a 2.0mm hole for positioning.
The distal shaft of the plate is manufactured in 3, 5, 8, 11 and 14 hole configurations with the first hole being a slot. These threaded holes are staggered through the length of the plate and accept a 4.0mm fully threaded cancellous locking screw or the 3.5mm cortical screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus, humeral head
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K011815, K04186
Reference Device(s)
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
1080590 C
Image /page/0/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a bold, sans-serif font. Below the letters is the text "ADVANCED ORTHOPAEDIC SOLUTIONS" in a smaller, sans-serif font. The letters are black, and the background is white.
510(k) SUMMARY
MAY - 6 2008
| SUBBMITTED BY: | Advanced Orthopaedic Solutions
2444 205TH Street, Unit 5
Torrance, CA 90501
(310) 533-9966
FAX (310) 533-9876 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT PERSON: | Paul Doner, Vice President Operations |
| TRADE NAME: | AOS Proximal Humeral Plate |
| COMMON NAME: | External Fixation |
| CLASSIFICATION: | 21 CFR 888.3030 Single/multiple component
metallic bone fixation appliances and
accessories. |
| DEVICE CODE: | KTW |
| SUBSTANTIALLY
EQUIVALENT DEVICE: | Synthes LCP Proximal Humeral Plate (K011815 and
K04186) |
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The AOS Proximal Humeral Plate is an internal fixation device for the fixation of fractures of the humeral head and is intended as a load sharing device which may be removed once the fracture has healed.
The plate is manufactured in multiple lengths with the overall length of the plate ranging from 97mm to 236mm. The proximal portion has eight 135° angled holes to accept 4.0mm locking screw. The distal portion has 3, 5, 8, 11 and 14 hole configurations which will accept a 4.0mm locking screw or a 3.5mm cortical screw. There are three associated screws for the AOS Proximal Humeral Plate; the 4.0mm fully threaded locking screws, the 4.0mm partially threaded locking screw and the 3.5mm cortical screw. The AOS Proximal Humeral Plates and screws are manufactured from tifanium alloy.
The overall length of the AOS Proximal Humeral Plate ranges from 97mm to 236mm while the proximal portion is consistent for all plates at 48mm. The proximal portion of the plate contains 8 threaded holes that accept the 4.0mm partially threaded cancellous locking screw. The proximal portion of the plate also contains six suture holes and a 2.0mm hole for positioning.
The distal shaft of the plate is manufactured in 3, 5, 8, 11 and 14 hole configurations with the first hole being a slot. These threaded holes are staggered through the length of the
1
plate and accept a 4.0mm fully threaded cancellous locking screw or the 3.5mm cortical screw.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The AOS Proximal Humeral Plate and the predicate Synthes (USA) Proximal Humeral Plate have the same indication for use, similar design geometry and are manufactured from similar material. Therefore, mechanical testing to support Substantial Equivalence was not necessary.
Both the AOS Proximal Humeral Plate and the predicated Synthes Proximal Humeral Plate are indicated for: "fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus."
For both systems there are screws with a threaded head configuration which are specifically designed to lock into the plate. The screws used in the two systems are also of similar configuration in thread form and major and minor thread diameter.
The screws used in the system were not mechanically tested because they are of similar major and minor diameter. The 3.5mm is already cleared for use in the AOS Humeral Nail (K050241).
As the AQS Proximal Humeral Plate and the predicated device have similar design geometry, are manufactured from similar material and have the same indication it was determined that mechanical testing was not necessary to support substantial equivalence.
INTENDED USE:
AOS Proximal Humeral Plate is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus.
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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 stylized eagle-like symbol with three overlapping, curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Orthopaedic Solutions % Mr. Paul Doner Vice President Operations 2444 205th Street, Unit 5 Torrance, CA 90501
MAY - 6 2008
Re: K080590 Trade/Device Name: AOS Proximal Humeral Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTW Dated: February 29, 2008 Received: March 3, 2008
Dear Mr. Doner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Paul Doner
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indication for Use Statement
510(k) Number (if known): _ K080590 (pg | / D
Device Name: AOS Proximal Humeral Plate
Indications for Use:
The AOS Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Prescription Use: X AND/OR (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)
Neil R.P. Ogle for rkn
Division S Division of General, Restorative and Neurological Devices
510(k) Number K080590
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