(85 days)
Not Found
Not Found
No
The summary describes a physical implant (a titanium plate and screws) for bone fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is designed to fuse carpal bones to address conditions like osteoarthritis, post-traumatic arthritis, fractures, carpal instability, and rheumatoid arthritis, aiming to relieve pain and restore function, which are therapeutic goals.
No
Explanation: The device is a fusion plate designed for surgical implantation to fuse carpal bones, which is a therapeutic treatment rather than a diagnostic function.
No
The device description explicitly states it is a "titanium fixation plate" and is used "in conjunction with screws," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the APTUS® 2.0/2.3 Four Corner Fusion Plate is a titanium fixation plate designed for surgical implantation to fuse carpal bones within the body. It is a surgical implant used to treat musculoskeletal conditions.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.
Product codes
HRS
Device Description
The APTUS® 2.0/2.3 Four Corner Fusion Plate consists of a titanium fixation plate designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carpal bones including: hamate, capitate, lunate, triquetrum and carpal bones of the hand.
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)
Not Found
Reference Device(s)
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
APTUS® 2.0/2.3 Four Corner Fusion Plate
K090983
510(k) Summary
Medartis AG APTUS® 2.0/2.3 Four Corner Fusion Plate
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:
Representative/Consultant:
Rosina Cifelli Regulatory Affairs Manager, Medartis AG
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: Common Name: Classification Regulations:
APTUS® 2.0/2.3 Four Corner Fusion Plate 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
Reviewing Branch: INTENDED USE
Classification Panel:
Product Code:
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.
Page 1 of 2
JUL - 1 2009
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510(k) Summary
DEVICE DESCRIPTION
The APTUS® 2.0/2.3 Four Corner Fusion Plate consists of a titanium fixation plate designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
EQUIVALENCE TO MARKETED DEVICE
Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS® 2.0/2.3 Four Corner Fusion Plate 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® 2.0/2.3 Four Corner Fusion Plate 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features an eagle-like emblem with three stylized lines forming its body and wings. The emblem is surrounded by text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
Medartis AG % Kevin A. Thomas, Ph.D. Senior Regulatory Specialist PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego. CA 92130
JUL - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Re: K090983
Trade/Device Name: APTUS® 2.0/2.3 Four Corner Fusion Plate Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II
Product Code: HRS Dated: June 22, 2009 Received: June 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 (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,
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Page 2- Kevin A. Thomas, Ph.D
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buehrig
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 (if known): K090983
APTUS® 2.0/2.3 Four Corner Fusion Plate Device Name: .
Indications for Use:
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.
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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