(87 days)
Not Found
No
The description focuses on the mechanical properties and design of a physical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to treat fractures, osteotomies, and arthrodeses, which are medical conditions, aligning with the definition of a therapeutic device.
No
The device, APTUS® Cannulated Compression Screws, is used for the treatment of fractures, osteotomies, and arthrodeses, which are therapeutic interventions, not diagnostic processes.
No
The device description clearly states it is a physical screw made of titanium alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of fractures, osteotomies, and arthrodeses of bones. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a surgical implant (screws) used to fix bone segments. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used in surgery.
N/A
Intended Use / Indications for Use
APTUS® Canulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodeses of bones e.g. in the hand, wrist, elbow, foot with the appropriate screw size.
Product codes
HWC
Device Description
APTUS Cannulated Compression Screws are headless screws provided in diameters of 2.2 and 3.0 mm, overall lengths from 10 to 40 mm, and threaded lengths from 3.5 to 18 mm. APTUS Cannulated Compression Screws have head and shaft threads with different pitch thus creating compression of the bone segments upon insertion of the screw. APTUS Cannulated Compression Screws are made of 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, wrist, elbow, foot
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 are provided to demonstrate substantial equivalence. This includes detailed dimensional analysis of the subject and predicate screw designs, and testing of the subject and predicate screw designs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021556, K050636, K063298, K070525, K043281, K071092
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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® Cannulated Compression Screws
K110658
510(k) Summary
JUN - 2 2011
Medartis AG APTUS® Cannulated Compression Screws
March 4, 2011
ADMINISTRATIVE INFORMATION
Manufacturer Name: Medartis AG Hochbergerstrasse 60E CH-4057 Basel, Switzerland Telephone: +41 61 633 34 34 +41 61 633 34 00 Fax: Official Contact: Ulrike Jehle Regulatory Affairs Manager, Medartis AG Kevin A. Thomas, PhD Representative/Consultant: 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: | APTUS® Cannulated Compression Screws |
|---|---|
| Common Name: | Screw, fixation, bone |
| Classification Regulations: | Smooth or threaded metallic bone fixation fastener |
| 21 CFR 888.3040, Class II | |
| Product Codes: | HWC |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
| INTENDED USE |
APTUS® Canulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodeses of bones e.g. in the hand, wrist, elbow, foot with the appropriate screw size.
Page 17 of 194
1
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DEVICE DESCRIPTION
APTUS Cannulated Compression Screws are headless screws provided in diameters of 2.2 and 3.0 mm, overall lengths from 10 to 40 mm, and threaded lengths from 3.5 to 18 mm. APTUS Cannulated Compression Screws have head and shaft threads with different pitch thus creating compression of the bone segments upon insertion of the screw. APTUS Cannulated Compression Screws are made of titanium alloy conforming to ASTM F136.
EQUIVALENCE TO MARKETED DEVICE
The APTUS Cannulated Compression Screws are substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Synthes (USA). Synthes (USA) 2.4 mm Cannulated Compression Screw, cleared under K021556;
Synthes (USA), Synthes (USA) 3.0 mm Headless Compression Screws, cleared under K050636:
OsteoMed L.P., OsteoMed Headless Cannulated Screw System, cleared under K063298; Wright Medical Technology, Inc., CHARLOTTE™ 7.0 MUC Screw and Washer, cleared under K070525:
Wright Medical Technology, Inc., CHARLOTTE™ High Demand Compression Screw, cleared under K043281; and
Howmedica Osteonics Corporation (now Stryker Corporation), Asnis™ III Cannulated Screw System, cleared under K071092.
APTUS Cannulated Compression Screws and the predicate devices are all compression screws having similar indications for use and are made of the same or similar materials. The subject and predicate devices are similar in overall shape and design, and encompass a similar range of physical dimensions, including screw thread diameter, overall length, and threaded length.
Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.
Performance data are provided to demonstrate substantial equivalence. This includes detailed dimensional analysis of the subject and predicate screw designs, and testing of the subject and predicate screw designs.
Overall, APTUS Cannulated Compression Screws have the following similarities to the predicate devices:
- has the same intended use, .
- uses the same operating principles, .
- incorporates the same basic designs, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medartis AG % PaxMEd International, LLC Kevin A. Thomas, PhD 11234 El Camino Real, Suite 200 San Diego, California 92130
JUN - 2 2011
Re: K110658
Trade/Device Name: APTUS® Cannulated Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 4, 2011 Received: March 7, 2011
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
3
Page 2 - Kevin A. Thomas, PhD
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/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 Small Manufacturers, International and Consumer Assistance 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/dcfault.htm.
Sincerely yours. Mark N. Melkers
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K | 10658 510(k) Number:
APTUS® Cannulated Compression Screws Device Name:
Indications for Use:
APTUS® Canulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodeses of bones e.g. in the hand, wrist, elbow, foot with the appropriate screw size.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(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)
| (Division Sign-Off) | Page 1 of __ | |
|---|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | ||
| 510(k) Number | K110658 |