(218 days)
No
The 510(k) summary describes a mechanical bone plate and screw system. There is no mention of AI, ML, image processing, or any software component that would typically incorporate such technologies. The performance studies are based on mechanical testing.
No.
The device is an orthopedic plate used to fix fractures and osteotomies, which is a supportive and corrective function, not a therapeutic one that would involve treating disease or dysfunction directly.
No
This device is described as an anatomical plate intended for the treatment of fractures and osteotomies of the ulna. It is a surgical implant designed to provide mechanical stability, not to diagnose a condition.
No
The device description clearly states it is a physical plate made of titanium, intended for surgical implantation. It also mentions compatible screws and K-wires, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fractures and osteotomies, in particular for the ulna." This describes a surgical implant used to treat bone conditions.
- Device Description: The description details a bone plate and compatible screws and K-wires, all of which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is clearly an in vivo (inside the body) surgical implant.
N/A
Intended Use / Indications for Use
ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The subject device APTUS Coronoid 2.0 plates have an anatomical design and are provided for the left and right ulna. The plates have a uniform thickness of 1.6 mm. The subject device plates are compatible with 2.0 mm diameter screws, and are used with TriLock locking screws and cortical (nonlocking) screws. The compatible screws have cortical threads, are presently marketed as part of the APTUS System, and were cleared under K051567 and K090053. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K142906), dimensional analysis, single cycle bending and bending fatigue testing of the subject device plates and the primary predicate device plates (according to ASTM F382), and dynamic compression testing of the subject device plates and the primary predicate device plates in a simulated coronoid fracture model. No clinical data were included in this submission.
Performance data provided to demonstrate substantial equivalence included single cycle bending and bending fatigue testing of the subject device and predicate device plate and screw constructs. In both single cycle bending and bending fatigue testing, the performance of the subject device constructs was superior to that of the predicate device constructs. In addition, in a simulated coronoid fracture model, the performance of the subject device constructs also was superior to that of the predicate device 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.
K071715, Acumed Congruent Bone Plate System, Acumed LLC
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.
K142906, APTUS® Wrist 2.5 System, Medartis AG
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
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Medartis AG Kevin Thomas Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K161861 Trade/Device Name: APTUS® Coronoid 2.0 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: January 11, 2017 Received: January 12, 2017
Dear Mr. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
APTUS® Coronoid 2.0
Indications for Use (Describe)
ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Medartis AG APTUS® Coronoid 2.0
January 11, 2017
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 | Andrea Schweizer
Head of Quality Management | |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
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® Coronoid 2.0 |
|---|---|
| Common Name | Plate, fixation, bone |
| Classification Names | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Classification Regulations | 21 CFR 888.3030 |
| Product Codes | HRS |
| Classification Panel | |
| Reviewing Branch | Orthopedic Products Panel |
| Joint Fixation Devices Branch Two (JFDB2) |
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PREDICATE DEVICE INFORMATION
Primary predicate device: K071715, Acumed Congruent Bone Plate System, Acumed LLC
Reference predicate device: K142906, APTUS® Wrist 2.5 System, Medartis AG
INDICATIONS FOR USE
ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
DEVICE DESCRIPTION
The subject device APTUS Coronoid 2.0 plates have an anatomical design and are provided for the left and right ulna. The plates have a uniform thickness of 1.6 mm. The subject device plates are compatible with 2.0 mm diameter screws, and are used with TriLock locking screws and cortical (nonlocking) screws. The compatible screws have cortical threads, are presently marketed as part of the APTUS System, and were cleared under K051567 and K090053. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K142906), dimensional analysis, single cycle bending and bending fatigue testing of the subject device plates and the primary predicate device plates (according to ASTM F382), and dynamic compression testing of the subject device plates and the primary predicate device plates in a simulated coronoid fracture model. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
Medartis AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K071715, Acumed Congruent Bone Plate System, Acumed LLC; and
K142906, APTUS® Wrist 2.5 System, Medartis AG.
A comparison of the technological characteristics of the subject device and the primary predicate device K071715 is provided in the following table.
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| Comparison | Subject Device | Primary Predicate Device |
|---|---|---|
| Comparison | Medartis AG | |
| APTUS® Coronoid 2.0 | Acumed | |
| Congruent Bone Plate System | ||
| K071715 | ||
| Indications for Use | ATPUS Ulna Plates are indicated for fractures and | |
| osteotomies, in particular for the ulna. | The Acumed Congruent Bone Plate System provides | |
| fixation for fractures, fusions, or osteotomies for the | ||
| clavicle, humerus, radius, ulna, metacarpal, | ||
| metatarsal, malleolus, tibia and fibula. | ||
| Plates | Information below for predicate coronoid plates | |
| Design | Anatomical plate designs for left and right ulna | Anatomical plate designs for left and right ulna |
| Thickness | 1.6 mm | 1.6 mm |
| Overall Dimensions | ||
| (approximate) | 28 mm x 34 mm (before bending) | (20-21 mm) x (31-35 mm) |
| Material | Unalloyed titanium ASTM F67, anodized blue | Unalloyed titanium ASTM F67; anodized blue, green |
| Screws | Information below for previously cleared compatible | |
| screws | ||
| Design | Self-tapping cortical (nonlocking) screws | |
| Self-tapping TriLock locking screws | Self-tapping cortical screws | |
| Self-tapping locking screws | ||
| Diameter | 2.0 mm | 2.7 mm |
| Length | Cortical screws 4 to 24 mm | |
| TriLock screws 6 to 30 mm | 8 to 32 mm | |
| Material | Ti-6Al-4V alloy, ASTM F136 | Ti-6Al-4V alloy, ASTM F136 |
The subject device coronoid plates and the primary predicate device coronoid plates have the same intended use and have the same technological characteristics. The subject and primary predicate device plates are fabricated from the same materials and share similar design characteristics, including plate screw holes to accommodate locking and non-locking screws. The subject and primary predicate device plates also are provided in pre-contoured designs for the left and right ulna, and encompass a similar range of physical dimensions appropriate to the coronoid anatomy. Any minor differences in the technological characteristics between the subject device and the primary predicate device do not raise new issues of safety or efficacy.
The subject and primary predicate device plates are provided nonsterile and are to be sterilized by the end-user. The subject devices are packaged using the same materials and are to be sterilized by the same methods as the reference predicate device.
All of the subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared reference predicate devices in K142906, and therefore are substantially equivalent to the reference predicate with regard to biocompatibility.
The wording of the Indications for Use for the subject device is slightly different than that of the primary predicate device; however, the slight differences in wording do not change the intended use of the subject device as compared to the primary predicate device.
6
Performance data provided to demonstrate substantial equivalence included single cycle bending and bending fatigue testing of the subject device and predicate device plate and screw constructs. In both single cycle bending and bending fatigue testing, the performance of the subject device constructs was superior to that of the predicate device constructs. In addition, in a simulated coronoid fracture model, the performance of the subject device constructs also was superior to that of the predicate device constructs.
Differences between the subject device and the primary predicate K071715 include differently shaped anatomic designs for the coronoid, and the use of 2.0 mm diameter screws (subject device) versus 2.7 mm diameter screws (primary predicate device). Substantial equivalence is supported by the single cycle and dynamic mechanical testing of the subject device and predicate device plate and screw constructs.
CONCLUSION
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and primary predicate device plates also are provided in pre-contoured designs for the left and right ulna, and encompass a similar range of physical dimensions appropriate to the coronoid anatomy. The subject and predicate devices are packaged in similar materials and are sterilized by the end-user using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.