(55 days)
Not Found
No
The device description and intended use are solely focused on a mechanical bone plate and screw system for fracture fixation. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is indicated for fractures, osteotomies, and non-unions of the distal tibia, which are medical conditions, and it consists of bone plates and screws designed to fix bone fragments, thus providing therapy for these conditions.
No
Explanation: This device is a bone plate and screw system designed for internal fixation of fractures, osteotomies, and non-unions, not for diagnosing medical conditions.
No
The device description explicitly states it consists of bone plates and bone screws, which are physical hardware components intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device consists of bone plates and screws intended for internal fixation of bone fragments after fractures. This is a surgical implant used directly within the body.
- Intended Use: The intended use is for treating fractures, osteotomies, and non-unions of the distal tibia. This is a structural and mechanical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for orthopedic fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
Product codes
HRS
Device Description
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 consists of:
LOQTEQ® Distal Anterolateral Tibia Plate 3.5 (left and right) to be used with LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapp. Cortical Screw 3.5, small head, self-tapping
Implants are made of Ti6A14V (ASTM F136 or ISO 5832-3)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia
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 tests have been performed and show the effectiveness and safety of the device.
Summary of Non-clinical tests:
Type of test: Implant Fatigue tests with progressive loadings, representing worst case scenario with respect to clinical use.
Assessment of test results: Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
oop Implantate AG
aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 ﻧ
K133675 page 1 of 2
Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AG
Lorenzweg 5
D-12099 Berlin Germany
JAN 2 3 2014 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dr. Christian Zietsch
Phone: +49-30-750-19 -193
Fax: +49-30-750-19 - 111 |
| Date | November 25 / 2013 |
| Trade Name: | aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 |
| Common Name: | Distal Anterolateral Tibia Plate |
| Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic
bone fixation appliances and accessories - Class II |
| Product Code | HRS |
| Predicate device: | Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal
Tibia Plates under the pre-market notification K092812
(May 11, 2010) |
| Device Description: | The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5
consists of bone plates and bone screws, to be implanted
by a surgeon in order to achieve an internal fixation of bone
fragments typically after fractures. If the plates are used in
conjunction with locking screws, a so called internal fixator
will be realized (internal fixation). |
| | The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5
consists of: |
| | LOQTEQ® Distal Anterolateral Tibia Plate 3.5 (left
and right)
to be used with LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapp. Cortical Screw 3.5, small head, self-tapping |
| Material: | Implants are made of Ti6A14V (ASTM F136 or ISO 5832-3) |
| Indications: | The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is
indicated for fractures, osteotomies, and non-unions of the
distal tibia, especially in osteopenic bone. |
.
1
Substantial Equivalence The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components and materials in use.
Documentation including mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.
Performance Data (Non-Clinical and / or Clinical):
Non-clinical tests have been performed and show the effectiveness and safety of the device.
Summary of Non-clinical tests:
Type of test:
Implant Fatigue tests with progressive loadings, representing worst case scenario with respect to clinical use.
Assessment of test results:
Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
January 23, 2014
aap Implantate AG Dr. Christian Zietsch Manager, Regulatory Affairs Lorenzweg 5. D-12099 Berlin GERMANY
Re: K133675
Trade/Device Name: aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 25, 2013 Received: November 29, 2013
Dear Dr. Zietsch:
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. Drue, 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
3
*Page 2 - Dr. Christian Zietsch
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 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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ronald Nean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
aop Implantate AG aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 : - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Indications for Use Statement
510(k) Number (if known): K133675
Device Name: aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5
Indications for Use:
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
Prescription Use × (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 OF NEEDED) ·
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth ank -S
Division of Orthopedic Devices
Page 1 of 1_