(52 days)
No
The device description focuses on the physical characteristics and materials of bone plates and screws, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not related to AI/ML performance metrics.
Yes
The device is intended for use in hand and forearm fractures, osteotomies, and arthrodeses, which are medical conditions that require treatment. It helps to stabilize bones during healing.
No
This device is a surgical implant (plates and screws) used for fixing fractures and performing osteotomies and arthrodeses, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly details physical plates made of unalloyed titanium, along with their dimensions and compatibility with screws and K-wires. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hand and forearm fractures, osteotomies, and arthrodeses." This describes a surgical implant used to treat musculoskeletal conditions.
- Device Description: The description details plates and screws made of titanium, designed to be implanted in the body.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo (inside the body) implant.
N/A
Intended Use / Indications for Use
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies, and arthrodeses.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The subject device plates have anatomic designs and are provided in two designs, each for the left and right radius: Lunate Facet Plate and Distal Radius Rim Plate. The Lunate Facet Plates have a maximum thickness of 1.6 mm, and maximum overall dimensions of approximately 19 mm x 47 mm before bending to conform to the anatomy of the distal radius. The Distal Radius Rim Plates have a maximum thickness of 1.8 mm, and maximum overall dimensions of approximately 22 mm x 53 mm before bending to conform to the anatomy of the distal radius. The screw holes of the subject device plates are designed to accommodate appropriately sized bone screws (locking and non-locking) presently marketed as part of the APTUS System and previously cleared under K142906, K103332, and K051567. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of unalloved 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
hand and forearm
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), engineering analysis, static mechanical testing (according to ASTM F382), and dynamic mechanical testing of the subject and predicate plate designs in a simulated fracture model. Clinical data were not provided in this submission. Performance data provided to demonstrate substantial equivalence included engineering analysis, single cycle bending and bending fatigue testing of the subject device and predicate device plates. In addition, in a simulated fracture models, the dynamic (fatigue) performance of the subject device constructs was superior to that of the predicate device constructs. Substantial equivalence is supported by the mechanical testing of the 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.
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/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2017
Medartis AG % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K172170
Trade/Device Name: APTUS® Wrist 2.5 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: July 17, 2017 Received: July 18, 2017
Dear Kevin 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
1
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 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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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® Wrist 2.5 System
Indications for Use (Describe)
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies, and arthrodeses.
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® Wrist 2.5 System
July 17, 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® Wrist 2.5 System |
|---|---|
| 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 | Orthopedic Products Panel |
| Reviewing Branch | Joint Fixation Devices Branch Two (JFDB2) |
PREDICATE DEVICE INFORMATION
The primary predicate device is K142906. The reference predicate device is K051567.
INDICATIONS FOR USE
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, and arthrodeses.
SUBJECT DEVICE DESCRIPTION
The subject device plates have anatomic designs and are provided in two designs, each for the left and right radius: Lunate Facet Plate and Distal Radius Rim Plate. The Lunate Facet Plates have a maximum thickness of 1.6 mm, and maximum overall dimensions of approximately 19 mm x 47 mm before bending to conform to the anatomy of the distal radius. The Distal Radius Rim Plates have a maximum thickness of 1.8 mm, and maximum overall dimensions of approximately 22 mm x 53 mm before bending to
4
510(k) Summary Page 2 of 3
conform to the anatomy of the distal radius. The screw holes of the subject device plates are designed to accommodate appropriately sized bone screws (locking and non-locking) presently marketed as part of the APTUS System and previously cleared under K142906, K103332, and K051567. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of unalloved 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), engineering analysis, static mechanical testing (according to ASTM F382), and dynamic mechanical testing of the subject and predicate plate designs in a simulated fracture model. Clinical data were not provided in this submission.
EQUIVALENCE TO MARKETED DEVICE
Medartis AG submits the 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:
K142906, APTUS® Wrist 2.5 System, Medartis AG
K051567, APTUS® Titanium System, Medartis, Inc.
A comparison of the technological characteristics of the subject device and the primary predicate device K142906 is provided in the following table.
| Comparison | Subject Device | Primary Predicate Device |
|---|---|---|
| APTUS Wrist 2.5 System | ||
| Medartis AG | K142906 | |
| APTUS Wrist 2.5 System | ||
| Medartis AG | ||
| Indications for Use | ||
| Statement | APTUS® Wrist 2.5 System is intended for use in hand | |
| and forearm fractures, osteotomies, and arthrodeses. | APTUS® Wrist 2.5 System is intended for use in hand | |
| and forearm fractures, osteotomies and arthrodeses. | ||
| Device Characteristics | ||
| Plate Designs | Anatomic plate designs (n=2) for left and right radius | |
| Lunate Facet Plate and Distal Radius Rim Plate | Anatomic plate designs (multiple) for left and right | |
| radius | ||
| Plate Thickness | Lunate Facet Plate – 1.6 mm | |
| Distal Radius Rim Plate - 1.8 mm | 0.6 mm to 3.2 mm | |
| Plate Overall Dimensions | ||
| (approximate) | Lunate Facet Plate - 19 mm width x 47 mm length | |
| Distal Radius Rim Plate – 22 mm width x 53 mm | ||
| length | Width: 7 mm to 36 mm | |
| Length: 7 mm to 184 mm | ||
| Plate Material | Unalloyed titanium, grade 4 (ASTM F67) | Unalloyed titanium, grade 4 (ASTM F67) |
| Information below for Subject Device is for previously cleared compatible screws | ||
| Screw Designs | Self-drilling and self-tapping; | |
| Cortical (conventional non-locking) and locking | Self-drilling and self-tapping; | |
| Cortical (conventional non-locking) and locking | ||
| Screw Diameter | 1.5 mm and 2.5 mm | 1.5 mm and 2.5 mm |
| Screw Length | 8 mm to 34 mm | 8 mm to 34 mm |
| Screw Material | Ti-6Al-4V alloy (ASTM F136) | Ti-6Al-4V alloy (ASTM F136) |
The subject device and the predicate device have the same intended use and the same Indications for Use statement.
The subject device and predicate device plates have the same technological characteristics are fabricated from the same materials and share similar design characteristics, including plate screw holes to accommodate locking and non-locking screws. The subject device and predicate device plates also are
5
provided in pre-contoured designs for the left and right radius, and encompass a similar range of physical dimensions appropriate to the anatomy. Any minor differences in the technological characteristics between the subject device and the predicate device do not raise new issues of safety or efficacy.
The subject device and predicate device plates are provided non-sterile and are to be sterilized by the enduser. The subject device components are packaged using the same materials and are to be sterilized by the same methods as the 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 predicate device components cleared in K142906, and therefore are substantially equivalent to the predicate device regarding biocompatibility.
Performance data provided to demonstrate substantial equivalence included engineering analysis, single cvcle bending and bending fatigue testing of the subject device and predicate device plates. In addition, in a simulated fracture models, the dynamic (fatigue) performance of the subject device constructs was superior to that of the predicate device constructs.
Differences between the subject device and predicate device plates include differently shaped anatomic designs for the distal radius. The subject device and predicate device plates have a similar overall shape and similar maximum plate thickness (subject device plates 1.6 mm, predicate plates 1.6 mm and 2.0 mm). Substantial equivalence is supported by the mechanical testing of the subject device and predicate device plate and screw constructs.
CONCLUSION
The subject device and the predicate device plates have the same intended use, have similar technological characteristics, and are made of the same material. The subject device and predicate device plates also are provided in pre-contoured anatomic designs for the left and right radius, and encompass a similar range of physical dimensions appropriate to the anatomy. The subject device and predicate device components are packaged in similar materials and are to be sterilized by the end-user using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices K142906 and K051567.