(104 days)
Not Found
No
The device description and performance studies focus on mechanical properties and anatomical fit of titanium plates and screws, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device is used to treat fractures, osteotomies, and non-unions of the distal humerus, which constitutes treatment and not therapy.
No
The device is described as a system of titanium locking plates, washers, and screws used for treatment (fractures, osteotomies, non-unions) of the distal humerus, not for diagnosis.
No
The device description clearly states it consists of titanium plates, washers, and screws, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the treatment of fractures, osteotomies, and non-unions of the distal humerus. This is a surgical implant used in vivo (within the body) to stabilize bone.
- Device Description: The description details titanium plates, washers, and screws, which are all components of a surgical implant system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
APTUS® Distal Humerus System is indicated for fractures, osteotomies and non-unions of the distal humerus.
Product codes
HRS, HWC
Device Description
The APTUS Distal Humerus System consists of titanium locking plates, 2.5/2.8 biconcave washers, and locking and non-locking titanium alloy screws. APTUS Distal Humerus plates are anatomically pre-contoured and provided in six designs: medial plate left/right, lateral plate left/right and posterolateral plate left/right; each of the plates is available in two lengths. The plates are used with TriLock locking screws, cortical screws or lag screws. APTUS Distal Humerus plates and washers are made of commercially pure titanium, grade 4, conforming to ASTM F67. TriLock locking, cortical, and lag screws are made of titanium alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus
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
Performance data provided to demonstrate substantial equivalence included engineering analysis and mechanical testing according to ASTM F543, and fatigue testing of subject and predicate device plate and screw constructs.
Key Metrics
Not Found
Predicate Device(s)
K091479, K103332, K033995, K101056
Reference Device(s)
Not Found
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
510(k) Summary K112560
DEC 1 5 2011
PTUS® Distal Humerus System
510(k) Summary
Medartis AG
APTUS® Distal Humerus System
K112560
November 14, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Medartis AG
Hochbergerstrasse 60E
CH-4057 Basel, Switzerland
Telephone: +41 61 633 34 34
Fax: +41 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 USA
Telephone: +1 (858) 792-1235
Fax: +1 (858) 792-1236 |
Email:
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | APTUS® Distal Humerus System |
|---|---|
| Common Names: | Plate, fixation, bone; Screw, fixation, bone |
| Classification Names: | Single/multiple component metallic bone fixation appliances and accessories |
| Smooth or threaded metallic bone fixation fastener | |
| Classification Regulations: | 21 CFR 888.3030, Class II |
| 21 CFR 888.3040, Class II | |
| Product Codes: | HRS, HWC |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
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510(k) Summary K112560
INTENDED USE
APTUS® Distal Humerus System is indicated for fractures, osteotomies and non-unions of the distal humerus.
DEVICE DESCRIPTION
The APTUS Distal Humerus System consists of titanium locking plates, 2.5/2.8 biconcave washers, and locking and non-locking titanium alloy screws. APTUS Distal Humerus plates are anatomically pre-contoured and provided in six designs: medial plate left/right, lateral plate left/right and posterolateral plate left/right; each of the plates is available in two lengths. The plates are used with TriLock locking screws, cortical screws or lag screws. APTUS Distal Humerus plates and washers are made of commercially pure titanium, grade 4, conforming to ASTM F67. TriLock locking, cortical, and lag screws are made of titanium alloy conforming to ASTM F136.
EQUIVALENCE TO MARKETED DEVICE
APTUS® Distal Humerus System is 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:
Medartis AG, APTUS® Foot System, cleared under K091479;
Medartis AG, APTUS® Ulna Plates, cleared under K103332;
Synthes (USA), Synthes (USA) 3.5 mm LCP Distal Humerus System, cleared under K033995; and
Howmedica Osteonics Corp., VariAx Elbow System, cleared under K101056.
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 engineering analysis and mechanical testing according to ASTM F543, and fatigue testing of subject and predicate device plate and screw constructs.
Overall, the APTUS Distal Humerus System has 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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2
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 with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medartis AG % PaxMed International, LLC Mr. Kevin A Thomas 11234 El Camino Real, Suite 200 San Diego, California 92130
DEC 1 5 2011
Re: K112560
Trade/Device Name: APTUS® Distal Humerus System Regulation Number: 2 1 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 31, 2011 Received: November 1, 2011
Dear Mr. Thomas:
We have reviewed your Section 51.0(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 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
3
Page 2 - Mr. Kevin A Thomas
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. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
APTUS® Distal Humerus System Device Name:
Indications for Use:
APTUS® Distal Humerus System is indicated for fractures, osteotomies and non-unions of the distal humerus.
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)
Z. N. S
(Division Sign-Off or MXM Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112560
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