(36 days)
No
The summary describes a mechanical device (screws and K-wires) for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the treatment of fractures, osteotomies, and arthrodeses of bones, which are therapeutic interventions.
No
This device is described as APTUS® Cannulated Compression Screws, which are used for the treatment of fractures, osteotomies, and arthrodeses of bones. These are therapeutic devices for internal fixation, not diagnostic devices which identify or detect a disease or condition.
No
The device description clearly states it is a physical implant (screws and K-wires) made of titanium alloy and stainless steel, intended for surgical implantation in bones. It does not describe any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of fractures, osteotomies, and arthrodeses of bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (screws and K-wires) made of metal, designed to provide mechanical support and compression to bone segments.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
This device is clearly a surgical implant used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTY
Device Description
APTUS® Cannulated Compression Screws 5.0, 7.0 are headless screws intended for the treatment of fractures, osteotomies and arthrodeses of bones. The design of the screw, incorporating various diameters, threads on the head and tip, provides compression of the bone segments upon insertion of the screw. The submission includes the associated Kwires, intended to be used for internal fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of the implants.
APTUS Cannulated Compression Screws 5.0, 7.0 are available in two diameters (5.0 mm and 7.0 mm) and come in partially-threaded or fully-threaded designs. The 5.0 mm screws are provided in overall lengths ranging from 30 to 70 mm. The 7.0 mm screws are provided in overall lengths ranging from 40 to 140 mm. The 5.0 and 7.0 mm screws are used with the 1.6 and 2.2 mm diameter K-wires, respectively.
APTUS® Cannulated Compression Screws 5.0, 7.0 are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and the K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones
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 data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and mechanical testing. APTUS® Cannulated Compression Screws 5.0, 7.0 were subjected to mechanical performance testing following the FDA recognized standard ASTM F543 Standard Specification and Test Method for Metallic Bone Screws. Side-by-side testing of screws was performed utilizing the subject and predicate devices cleared in K080943, K962011, and K080850.
Clinical data were not submitted in this premarket notification.
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.
K092038, K110658, K080943, K962011, K080850
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
§ 888.3040 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
510(k) Summary
K133460 page 1 of 3
DEC 18 2013
・・・
Medartis AG
APTUS® Cannulated Compression Screws 5.0, 7.0
November 11, 2013
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
Representative/Consultant
Andrea Schweizer Group Manager Compliance & Vigilance
Allison C. Komiyama, Ph.D. 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: akomiyama@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name Common Name
Classification Name Classification Regulations Product Code
Classification Panel Reviewing Branch
APTUS® Cannulated Compression Screws Screw, fixation, bone
Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040. Class II HWC. HTY
Orthopedic Products Panel Orthopedic Devices Branch
1
K133460 page 2 of 3
INTENDED USE
APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.
DEVICE DESCRIPTION
APTUS® Cannulated Compression Screws 5.0, 7.0 are headless screws intended for the treatment of fractures, osteotomies and arthrodeses of bones. The design of the screw, incorporating various diameters, threads on the head and tip, provides compression of the bone segments upon insertion of the screw. The submission includes the associated Kwires, intended to be used for internal fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of the implants.
APTUS Cannulated Compression Screws 5.0, 7.0 are available in two diameters (5.0 mm and 7.0 mm) and come in partially-threaded or fully-threaded designs. The 5.0 mm screws are provided in overall lengths ranging from 30 to 70 mm. The 7.0 mm screws are provided in overall lengths ranging from 40 to 140 mm. The 5.0 and 7.0 mm screws are used with the 1.6 and 2.2 mm diameter K-wires, respectively.
APTUS® Cannulated Compression Screws 5.0, 7.0 are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and the K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
EQUIVALENCE TO MARKETED DEVICE
APTUS® Cannulated Compression Screws 5.0, 7.0 are substantially equivalent in indications and design principles to the following predicate devices:
- Medartis AG, APTUS® K-Wire System (K092038) .
- Medartis AG, APTUS® Cannulated Compression Screws (K110658) .
- Synthes (USA), Synthes 4.5 mm and 6.5 mm Headless Compression Screws (K080943) .
- . Synthes (USA), Synthes 7.0/7.3 mm Cannulated Screws (K962011)
- Wright Medical Technology, Inc., DARCO® Headless Compression Screw (K080850) .
APTUS® Cannulated Compression Screws 5.0. 7.0 have similar designs and identical materials as those cleared under K092038 and K110658. The subject device is similar in indications to those cleared in K110658, K080943, K962011, and K080850. The designs and dimensions of the subject device are similar and within the range of those cleared in K080943. K962011, and K080850.
2
510(k) Summary
K133460 page 3 of 3
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and mechanical testing. APTUS® Cannulated Compression Screws 5.0, 7.0 were subjected to mechanical performance testing following the FDA recognized standard ASTM F543 Standard Specification and Test Method for Metallic Bone Screws. Side-by-side testing of screws was performed utilizing the subject and predicate devices cleared in K080943, K962011, and K080850.
Clinical data were not submitted in this premarket notification.
Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
Overall. APTUS® Cannulated Compression Screws 5.0, 7.0 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. .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2013
Medartis AG % Allison C. Komiyama, Ph.D. PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K133460
Trade/Device Name: APTUS® Cannulated Compression Screws 5.0, 7.0 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: November 11, 2013 Received: November 12, 2013
Dear Dr. Komiyama:
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. Iisting 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 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.
4
$\frac{1}{2} + \frac{1}{4} + \frac{1}{8} + \frac{1}{16} + \ldots$
Page 2 - Allison C. Komiyama. Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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 CDRH1'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/default.htm.
Sincerely vours.
Ronalding Nean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
5.10(k) Summary
APTUS® Cannulated Compression Screws 5.0, 7.0
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Indications for Use
K133460 510(k) Number:
APTUS® Cannulated Compression Screws 5.0, 7.0 Device Name:
Indications for Use:
APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures. osteotomies and arthrodeses of bones with the appropriate screw size.
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 I of I
Elizabeth & Frank -S
Division of Orthopedic Devices