(29 days)
The AOS Clavicle Plate System provides fixation for fractures, fusions, or osteotomies for the Clavicle.
The AOS Clavicle Plate System consists of bone plates and screws for fractures, fusions, and osteotomies of the Clavicle bone. The bone plates are pre-shaped to fit the curves and angles of the Clavicle and are provided in a range of curvatures and sizes. The plates accept both locking and nonlocking screws. The proposed new plates are shorter versions of the lateral and midshaft plates currently in the system. The 6 Hole Medium Midshaft Superior Clavicle Plate and 6 Hole Straight Midshaft Superior Clavicle Plate both come in right and left versions and follow the same basic curvature as that of the existing 8 Hole Medium and Straight Midshaft Clavicle Plates, respectively. The Short Lateral Superior Clavicle Plates come in right and left versions and follow the same basic geometry as the current lateral superior plates, with the addition of an elongated hole. The elongated hole will be used for provisional placement with the ability to adjust the plate positioning. All plates except for the short lateral plates have at least one bending notch. This notch feature is used for fine adjustment of the plate geometry in order to fit the plate more intimately with the bone surface.
The provided text is a 510(k) summary for the AOS Short Clavicle Plates. It describes a medical device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document states: "As detailed in the submission, the proposed plates do not present a worst-case scenario with respect to strength characteristics, and because of their similarity to the current plates, physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed plates and the predicate plates."
This indicates that the device was approved based on substantial equivalence to an existing predicate device (AOS Clavicle Plate System, K103513), due to similarities in:
- Indications for use
- Geometry and design
- Fundamental scientific technology
- Material (Ti-6Al-4V ELI, per ASTM F136)
Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets acceptance criteria, as this information is not present in the provided text. The approval was based on a comparison to a predicate device rather than a new performance study with specific acceptance criteria.
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K12-623
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Image /page/0/Picture/2 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, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The logo is simple and professional, and it conveys the company's focus on orthopaedics.
SEP 2 6 2012
8. SPECIAL 510(K) SUMMARY
SUMMARY PREPARED ON:
August 27, 2012
SUBMITTED BY:
Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966
CONTACT PERSON:
Allyson Parks Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966
Class II, 21 CFR 888.3030 Single/multiple
component metallic bone fixation appliances and
AOS Short Clavicle Plates
Internal Fixation
accessories
HRS
DEVICE NAME: COMMON NAME: CLASSIFICATION:
DEVICE CODE:
SUBSTANTIALLY EQUIVALENT DEVICE:
DEVICE DESCRIPTION:
AOS Clavicle Plate System (K103513, October 24, 2011)
The AOS Clavicle Plate System consists of bone plates and screws for fractures, fusions, and osteotomies of the Clavicle bone. The bone plates are pre-shaped to fit the curves and angles of the Clavicle and are provided in a range of curvatures and sizes. The plates accept both locking and nonlocking screws.
The proposed new plates are shorter versions of the lateral and midshaft plates currently in the system. The 6 Hole Medium Midshaft Superior Clavicle Plate and 6 Hole Straight Midshaft Superior Clavicle Plate both come in right and left versions and follow the same basic curvature as that of the existing 8 Hole Medium and Straight Midshaft Clavicle Plates, respectively. The Short Lateral Superior Clavicle Plates come in right and left versions and follow the same basic geometry as the current lateral superior plates, with the addition of an elongated hole. The
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122623
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elongated hole will be used for provisional placement with the ability to adjust the plate positioning.
All plates except for the short lateral plates have at least one bending notch. This notch feature is used for fine adjustment of the plate geometry in order to fit the plate more intimately with the bone surface.
The AOS Clavicle Plate System provides fixation for fractures, fusions, or osteotomies for the Clavicle.
INDICATIONS FOR USE:
SUBSTANTIAL EQUIVALENCE:
Information presented supports substantial equivalence of the AOS Short Clavicle Plates to the predicate device. The proposed plates have the same indications for use, are similar in geometry and design, have the same fundamental scientific technology, and are made of the same material (Ti-6Al-4V ELI, per ASTM F136) as the predicate plates. As detailed in the submission, the proposed plates do not present a worst-case scenario with respect to strength characteristics, and because of their similarity to the current plates, physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed plates and the predicate plates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 6 2012
Advanced Orthopaedic Solutions, Incorporated % Ms. Allyson Parks Regulatory Associate 386 Beech Avenue, Unit B6 Torrance, California 90501
Re: K122623
Trade/Device Name: AOS Short Clavicle Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II
Product Code: HRS Dated: August 27, 2012 Received: August 28, 2012
Dear Ms. Parks:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 -Ms. Allyson Parks
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. INDICATIONS FOR USE STATEMENT
Special 510(k) Premarket Notification Indication for Use Statement AOS Short Clavicle Plates
510(k) Number (if known): K122623
Device Name: AOS Short Clavicle Plates
Indications for Use:
The AOS Clavicle Plate System provides fixation for fractures, fusions, or osteotomies for the Clavicle.
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)
Asht
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122623
N/A