(41 days)
Not Found
No
The device description and performance studies focus on mechanical properties and design, with no mention of AI/ML terms or data processing.
Yes.
This device is used to treat fractures and osteotomies of the ulna, which are conditions that require therapy.
No
The device, APTUS Ulna Plates, is described as a system for fixing fractures and osteotomies of the ulna using plates and screws. Its function is to provide mechanical support and stabilization, not to diagnose medical conditions.
No
The device description explicitly states it consists of titanium locking plates and screws, which are hardware components.
Based on the provided text, 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 fix bones, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details titanium plates and screws, which are physical implants.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing procedures.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
APTUS® 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, HWC
Device Description
APTUS Ulna Shortening 2.5 system consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and nonlocking. 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
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)
Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate device designs, engineering analysis and dynamic mechanical testing of the subject and predicate plate designs.
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.
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
.
:
1
APTUS® Ulna Shortening 2.5
510(k) Summary
Medartis AG
APTUS® Ulna Shortening 2.5
May 12, 2014
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 |
| Group Manager Compliance & Vigilance | |
| 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® Ulna Shortening 2.5 |
|---|---|
| Common Name: | Plate, fixation, bone |
| Screw, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Smooth or threaded metallic bone fixation fastener | |
| Classification Regulation: | 21 CFR 888.3030, 21 CFR 888.3040, Class II |
| Product Code: | HRS, HWC |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Joint Fixation Devices Branch Two (JFDB2) |
1
510(k) Summary
APTUS® Ulna Shortening 2.5
INTENDED USE
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
DEVICE DESCRIPTION
APTUS Ulna Shortening 2.5 system consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and nonlocking. 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.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the following predicate devices:
Medartis, Inc., APTUS® Titanium Fixation System, cleared under K051567;
Medartis AG. APTUS® Ulna Plates, cleared under K103332; and
TriMed Inc., TriMed Ulnar Osteotomy Plate, cleared under K043263.
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, and a screw hole angled for placement of a screw perpendicular to a 45° osteotomy. 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 of the subject and predicate device designs, engineering analysis and dynamic mechanical testing of the subject and predicate plate designs.
Overall, APTUS® Ulna Shortening 2.5 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.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MI) 20993-0002
June 23, 2014
Medartis AG % Mr. Kevin A. Thomas, PhD Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego. California 92130
Re: K141232
Trade/Device Name: APTUS™ Ulna Shortening 2.5 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 12, 2014 Received: May 13. 2014
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. 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
3
Page 2 - Kevin A. Thomas, PhD
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.
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" (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/MedicalDcvices/Safety/ReportaProblem/default.hun 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 yours,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K141232 510(k) Number:
APTUS® Ulna Shortening 2.5 Device Name:
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
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)
Page 1 of 1
Elizabet情況
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K141232