(73 days)
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
The APTUS Ulna Plates consists of titanium locking plates and locking and non-locking titanium screws. APTUS Ulna Plates are provided in four designs: Y (distal ulna), Olecranon Straight, Olecranon Right/Left and Olecranon Tension. The plates are used with TriLock locking screws, cortical screws or lag screws (all of which have cortical threads). APTUS Ulna Plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 and TriLock locking and cortical screws are made of titanium alloy conforming to ASTM F136.
The provided text describes a 510(k) premarket notification for the APTUS® Ulna Plates, which are orthopedic fixation devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting de novo clinical studies with specific acceptance criteria in the way a diagnostic AI device would.
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set), is not applicable to this 510(k) submission for APTUS® Ulna Plates.
Instead, the submission relies on performance data provided to demonstrate substantial equivalence, which included:
- Detailed dimensional analysis of the subject and predicate plate designs.
- Fatigue testing of the subject and predicate plate design constructs.
The "acceptance criteria" here are implicitly that the APTUS® Ulna Plates perform as safely and effectively as the predicate devices in these engineering tests, confirming similar mechanical properties suitable for their intended use. The study "proves" the device meets these (unspecified numerical) acceptance criteria by demonstrating that the mechanical performance is comparable to devices already deemed safe and effective by the FDA.
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510(k) Summary
APTUS® Ulna Plates
K103332
pg 1/2
510(k) Summary
Medartis AG APTUS® Ulna Plates
JAN 2 4 2011
November 10, 2010
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Medartis AG |
|---|---|
| Hochbergerstrasse 60E | |
| CH-4057 Basel, Switzerland | |
| Telephone: | +41 (0) 61 633 34 34 |
| Fax: | +41 (0) 61 633 34 00 |
| Official Contact: | Ulrike Jehle |
| Regulatory Affairs Manager, Medartis AG | |
| Representative/Consultant: | Kevin A. Thomas, PhD |
| Floyd G. Larson | |
| PaxMed International, LLC | |
| 11234 El Camino Real, Suite 200 | |
| San Diego, CA 92130 | |
| Telephone: | +1 (858) 792-1235 |
| Fax: | +1 (858) 792-1236 |
| Email: | kthomas@paxmed.com |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | APTUS® Ulna Plates |
|---|---|
| Common Name: | Plate, fixation, bone |
| Screw, fixation, bone | |
| Classification Regulations: | Single/multiple component metallic bone fixationappliances |
| 21 CFR 888.3030, Class II | |
| Smooth or threaded metallic bone fixation fastener | |
| 21 CFR 888.3040, Class II | |
| Product Codes: | HRS, HWC |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
INTENDED USE
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
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APTUS® Ulna Plates
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DEVICE DESCRIPTION
The APTUS Ulna Plates consists of titanium locking plates and locking and non-locking titanium screws. APTUS Ulna Plates are provided in four designs: Y (distal ulna), Olecranon Straight, Olecranon Right/Left and Olecranon Tension. The plates are used with TriLock locking screws, cortical screws or lag screws (all of which have cortical threads). APTUS Ulna Plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 and TriLock locking and cortical screws are made of titanium alloy conforming to ASTM F136.
EQUIVALENCE TO MARKETED DEVICE
APTUS Ulna Plates are substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
APTUS® Titanium Fixation System cleared under K051567,
APTUS® K-Wire cleared under K092038,
Synthes USA, Synthes (USA) Modular Mini Fragment LCP System, cleared under K063049,
The Synthes (USA) 3.5 / 4.5 mm LCP Metaphyseal Plates, cleared under K033805.
The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics. The subject and predicate devices encompass the same range of physical dimensions, are packaged using the same materials, and are to be sterilized by the same methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.
Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate plate designs, and fatigue testing of the subject and predicate plate design constructs.
Overall, APTUS Ulna Plates have the following similarities to the predicate devices:
- has the same intended use. .
- uses the same operating principles, .
- incorporates the same basic designs, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medartis AG % PaxMed International, LLC Kevin A. Thomas, PhD Regulatory Affairs Manager 11234 El Camino Real, Suite 200 San Diego, California 92130
JAN 2 4 2011
Re: K103332
Trade/Device Name: APTUS® Ulna Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single / multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 10, 2010 Received: November 12, 2010
Dear Dr. Thomas:
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 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
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Page 2 - Kevin A. Thomas, PhD
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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
A. B. Roth
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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APTUS® Ulna Plates
Indications for Use
510(k) Number (if known):
APTUS® Ulna Plates Device Name:
Indications for Use:
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Page 1 of | |
| for m. Wilkerson | |
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K103332 |
| Page 15 of 162 |
§ 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.