(105 days)
Not Found
No
The summary describes a mechanical implant system for bone fixation and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device, APTUS® Proximal Humerus System, is indicated for fractures, osteotomies, and non-unions of the proximal humerus. It is an orthopedic implant designed to mechanically fix bones and support healing by providing stability. It does not actively treat or cure a disease but rather supports the body's natural healing process in a structural capacity.
No
The device is described as an implant system for fractures, osteotomies, and non-unions, and its components include plates, screws, and spiral blades, all of which are used for surgical fixation, not for diagnosing conditions.
No
The device description explicitly lists hardware components made of titanium (plates, screws, spiral blades).
Based on the provided information, the APTUS® Proximal Humerus System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating fractures, osteotomies, and non-unions of the proximal humerus. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of plates, screws, and spiral blades made of titanium. These are implants used to stabilize bone, not reagents or instruments for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, the APTUS® Proximal Humerus System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
APTUS Proximal Humerus System consists of titanium locking plates, locking and non-locking titanium screws, spiral blades left/ right and the corresponding screws for the spiral blades. The plates are used with TriLock locking screws and cortical screws. APTUS Proximal Humerus plates and spiral blades are made of commercially pure titanium, grade 4, conforming to ASTM F67. TriLock locking and cortical 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
proximal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data provided to demonstrate substantial equivalence included detailed dimensional and engineering analysis of the subject and predicate devices, and fatigue testing of subject device and predicate device plate and screw constructs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
·APTUS® Proximal Humerus System
510(k) Summary K120108
APR 2 7 2012
510(k) Summary
Medartis AG
APTUS® Proximal Humerus System K120108
April 26, 2012
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: kthomas@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Name:
Classification Regulation: Product Code:
Classification Panel: Reviewing Branch:
APTUS® Proximal Humerus System Plate, fixation, bone Single/multiple component metallic bone fixation appliances and accessories
21 CFR 888.3030, Class II HRS
Orthopedic Products Panel Orthopedic Devices Branch
1
510(k) Summary K120108
INTENDED USE
APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.
DEVICE DESCRIPTION
APTUS Proximal Humerus System consists of titanium locking plates, locking and non-locking titanium screws, spiral blades left/ right and the corresponding screws for the spiral blades. The plates are used with TriLock locking screws and cortical screws. APTUS Proximal Humerus plates and spiral blades are made of commercially pure titanium, grade 4, conforming to ASTM F67. TriLock locking and cortical screws are made of titanium alloy conforming to ASTM F136.
EQUIVALENCE TO MARKETED DEVICE
APTUS® Proximal Humerus System is substantially equivalent in indications and design principles to the following legally marketed predicate devices, each of which has been determined by FDA to be substantially equivalent to a legally marketed predicate device:
Synthes (USA), Synthes LCP Proximal Humerus Plate, cleared under K011815;
Synthes (USA), Synthes (USA) LCP® Proximal Humerus Plates, long, cleared under K041860; and
Exactech, Inc., Exactech® Equinoxe® Proximal Humerus Fracture Plate System, cleared under K093978.
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 and engineering analysis of the subject and predicate devices, and fatigue testing of subject device and predicate device plate and screw constructs.
Overall, the APTUS Proximal 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. .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes, symbolizing growth and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medartis AG % Paxmed International LLC Dr. Kevin A. Thomas Vice President and Director of Regulatory Affairs 11234 El Camino Real, Suite 200 San Diego, California 92130
APR 2 7 2012
Re: K120108 Trade/Device Name: APTUS® Proximal Humerus System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: April 23, 2012 Received: April 24, 2012
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.
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
3
Page 2 - Kevin A. Thomas, PhD
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
4
Indications for Use
510(k) Number:
Device Name:
APTUS® Proximal Humerus System
Indications for Use:
APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal 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)
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Ast
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
K120108 510(k) Number _