(246 days)
No
The device description and performance studies focus on the mechanical properties and design of titanium plates and screws, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, APTUS® Wrist 2.5 System, is intended for use in hand and forearm fractures, osteotomies and arthrodeses, which are conditions that require treatment for medical conditions and therefore qualify it as a therapeutic device.
No
The device description and intended use indicate that the APTUS® Wrist 2.5 System is composed of titanium plates and screws used for fixation in specific bone fractures, osteotomies, and arthrodeses, which are therapeutic and reconstructive purposes, not diagnostic.
No
The device description explicitly states that the device consists of titanium locking plates and screws, which are hardware components. There is no mention of software as the primary or sole component of the device.
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 fix bones, not a test performed on biological samples to diagnose a condition.
- Device Description: The device consists of "titanium locking plates" and "titanium screws." These are physical implants, not reagents, instruments, or software used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or assays
- Analysis of biomarkers
The APTUS® Wrist 2.5 System is a surgical implant used for orthopedic fixation.
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
HRS, HWC
Device Description
APTUS Wrist 2.5 System consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and non-locking. This submission includes additional lengths of non-locking screws. Plates have a low overall height, rounded edges, polished surfaces and incorporate TriLock Technology with use of TriLock (locking) screws. All plates are made from unalloyed titanium conforming to ASTM F67, and all screws are made from 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
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)
Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis and engineering analysis of the subject and predicate device designs. Mechanical testing conducted on the subject screws in comparison with the predicate screws demonstrated substantial equivalence in screw performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051567, K103332, K040022, K070946
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be emerging from a single point. 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 Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2015
Medartis AG % Mr. Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K142906 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, HWC Dated: May 7, 2015 Received: May 8, 2015
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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. 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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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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3
510(k) Summary
Medartis AG
APTUS® Wrist 2.5 System
June 2, 2015
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, Medartis AG | |
| Representative/Consultant | | | Kevin A. Thomas, PhD
Floyd G. Larson
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 |
| Screw, fixation, bone | |
| Classification Names | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Smooth or threaded metallic bone fixation fastener | |
| Classification Regulations | 21 CFR 888.3030, 21 CFR 888.3040, Class II |
| Product Codes | HRS, HWC |
| Classification Panel | Orthopedic Products Panel |
| Reviewing Branch | Joint Fixation Devices Branch Two (JFDB2) |
4
INTENDED USE
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
DEVICE DESCRIPTION
APTUS Wrist 2.5 System consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and non-locking. This submission includes additional lengths of non-locking screws. Plates have a low overall height, rounded edges, polished surfaces and incorporate TriLock Technology with use of TriLock (locking) screws. All plates are made from unalloyed titanium conforming to ASTM F67, and all screws are made from titanium alloy conforming to ASTM F136.
The subject device is substantially equivalent in indications and design principles to the following predicate devices:
K051567, APTUS® Titanium Fixation System, Medartis, Inc.
K103332, APTUS® Ulna Plates, Medartis AG
K040022, Stryker® Leibinger Universal Distal Radius System, Stryker Leibinger
K070946, Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plate, Synthes (USA)
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, including plate screw holes to accommodate locking and non-locking screws. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the predicate devices K103332 and K051567. The subject and predicate devices 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 analysis and engineering analysis of the subject and predicate device designs. Mechanical testing conducted on the subject screws in comparison with the predicate screws demonstrated substantial equivalence in screw performance.
Overall, APTUS® Wrist 2.5 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 or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. ●