(105 days)
Not Found
Not Found
No
The summary describes a mechanical fixation system and makes no mention of AI or ML.
Yes
The device is described as a "fixation system" for "internal fixation of small bones" in "proximal radial fractures and osteotomies," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device description indicates it is a system of plates and screws for internal fixation of fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of physical components (titanium fixation plates, conventional screws, and locking screws), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the APTUS® 2.0 Radial Head System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the internal fixation of proximal radial fractures and osteotomies. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates and screws, which are implants used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The provided description does not mention any such use or interaction with biological specimens.
Therefore, the APTUS® 2.0 Radial Head System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The APTUS® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The APTUS® 2.0 Radial Head System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal radial
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)
Not Found
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.
Not Found
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
510(k) Summary
KO4005 3 2
APTUS® 2.0 Radial Head System
510(k) Summary
APR 2 3 2009
Medartis AG APTUS® 2.0 Radial Head System
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Medartis AG
Austrasse 24
CH-4051 Basel, Switzerland
Telephone: +41 (0) 61 228 18 18
Fax: +41 (0) 61 228 18 00 . |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Rosina Cifelli
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® 2.0 Radial Head System |
|---|---|
| Common Name: | Plate, fixation, bone |
| Classification Regulations: | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| 21 CFR 888.3030 | |
| Class II | |
| Product Code: | HRS |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
INTENDED USE
The APTUS® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.
1
510(k) Summary
DEVICE DESCRIPTION
The APTUS® 2.0 Radial Head System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones.
EQUIVALENCE TO MARKETED DEVICE
Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS® 2.0 Radial Head System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices. Overall, the APTUS® 2.0 Radial Head System has the following similarities to the predicate devices:
- has the same intended use, .
- . uses the same operating principle,
- . incorporates the same basic design,
- . incorporates the same 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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2009
Medartis AG % Kevin A. Thomas, PhD PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130
Re: K090053
Trade/Device Name: APTUS 2.0 Radial Head System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 20, 2009 Received: March 23, 2009
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 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.
3
Page 2 - Kevin A. Thomas, PhD
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For Pete Nmn
Des Dr
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APTUS® 2.0 Radial Head System
Indications for Use
510(k) Number (if known): K090053
·
APTUS® 2.0 Radial Head System Device Name:
Indications for Use:
The APTUS® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative,
Concurrence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devices
| 510(k) Number | 4090083 |
|---|---|
| Page 1 of |
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