(154 days)
The indication for use of the aap LOQTEQ® Osteotomy System are:
LOQTEQ® High Tibial Osteotomy Plate 4.5:
- Open-wedge osteotomies at the proximal medial tibia .
- Treatment of bone and joint deformities .
- Treatment of malpositions caused by injuries or disorders such as . osteoarthritis
LOQTEQ® Distal Femur Osteotomy Plate 4.5:
- Closed-wedge osteotomies of the medial distal femur .
- Treatment of bone and joint deformities .
- Treatment of malpositions caused by injuries or disorders such as . osteoarthritis
The aap LOQTEQ® Osteotomy System 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 osteotomy of medial proximal tibia and medial distal femur. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap LOQTEQ® Osteotomy System consists of:
LOQTEQ® LOQTEQ® High Tibial Osteotomy Plate 4.5
LOQTEQ® LOQTEQ® Distal Femur Osteotomy Plate 4.5 (left and right)
LOQTEQ® Cortical Screw 4.5, small head, T25, self-tapping
Cortical Screw 4.5, small head, self-tapping
LOQTEQ® Cortical Screw 4.5, T25, self-tapping
Set of Instruments aap LOQTEQ® Osteotomy System Set of Instruments
This document describes the aap LOQTEQ® Osteotomy System, a medical device consisting of bone plates and screws designed for internal fixation after osteotomy procedures (medial proximal tibia and medial distal femur). The information provided focuses on its substantial equivalence to predicate devices and its non-clinical performance.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance of the aap system | Substantial equivalence to predicate device with respect to mechanical performance based on test results gained. (Implicitly, the performance meets the requirements of its pre-defined acceptance criteria, although the specific numerical criteria are not detailed in this summary.) |
| Safety and effectiveness (general) | The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as this is a non-clinical study. The "test set" refers to mechanical test samples, not patient data.
- Data Provenance: Non-clinical tests (lab-based mechanical testing). The country of origin for the testing data is not specified, but the sponsor is based in Berlin, Germany. The study is prospective in the sense that the tests were designed and conducted to evaluate the device.
3. Number of Experts and Qualifications
This document describes non-clinical mechanical testing, not a study involving human experts for ground truth establishment. Therefore, this information is not applicable.
4. Adjudication Method
Not applicable, as this is a non-clinical mechanical performance study, not a study evaluating human interpretation or expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes non-clinical mechanical testing of a medical device, not a comparative effectiveness study involving human readers and AI.
6. Standalone Performance Study (Algorithm Only)
Not applicable, as this is a physical medical device (bone plates and screws), not an algorithm or AI. The "standalone performance" refers to the mechanical performance of the device itself.
7. Type of Ground Truth Used
The "ground truth" for this non-clinical study is established through physical mechanical testing according to predefined test protocols, likely based on industry standards (e.g., ISO, ASTM) and worst-case scenarios with respect to clinical use. The comparison is made against the mechanical performance of the predicate devices.
8. Sample Size for the Training Set
Not applicable. This is a non-clinical evaluation of a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of this non-clinical mechanical performance study.
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Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AGLorenzweg 5D-12099 Berlin Germany |
|---|---|
| Company Contact: | Dr. Christian ZietschPhone:+49-30-750-19 -193Fax: +49-30-750-19 - 111 |
| Date | November 08 / 2013 |
| Trade Name: | aap LOQTEQ® Osteotomy System |
| Common Name: | Osteotomy System |
| Classification Name andReference: | 21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories - Class II |
| Product Code: | HRS |
| Predicate device: | Synthes TomoFix™ Osteotomy System under the pre-market notification K023941 (Jan 23, 2003) and Synthes(USA) TomoFiXTM Medial Distal Femur Plates under thepremarket notification K081353 (Jul 23, 2008). |
| Device Description: | The aap LOQTEQ® Osteotomy System consists of boneplates and bone screws, to be implanted by a surgeon inorder to achieve an internal fixation of bone fragments typi-cally after osteotomy of medial proximal tibia and medialdistal femur. If the plates are used in conjunction with lock-ing screws, a so called internal fixator will be realized (in-ternal fixation).The aap LOQTEQ® Osteotomy System consists of:LOQTEQ® LOQTEQ® High Tibial Osteotomy Plate 4.5LOQTEQ® LOQTEQ® Distal Femur Osteotomy Plate 4.5 (left and right)LOQTEQ® Cortical Screw 4.5, small head, T25, self-tappingCortical Screw 4.5, small head, self-tappingLOQTEQ® Cortical Screw 4.5, T25, self-tappingSet of Instruments aap LOQTEQ® Osteotomy System Set of Instruments |
| Material: | Implants are made of Ti6AI4V (ASTM F136 or ISO 5832-3) |
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oop Implantate AG aap LOQTEQ® Osteotomy System
LOQTEQ® High Tibial Osteotomy Plate 4.5: Indications: Open-wedge osteotomies at the proximal medial 1 tibia Treatment of bone and joint deformities -Treatment of malpositions caused by injuries or disorders such as osteoarthritis LOQTEQ® Distal Femur Osteotomy Plate 4.5: Closed-wedge osteotomies of the medial distal femur Treatment of bone and joint deformities -Treatment of malpositions caused by injuries or disorders such as osteoarthritis 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 tests have been performed and show (Non-Clinical and / the effectiveness and safety of the device. or Clinical): 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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2013
aap Implantate AG Dr. Christian Zietsch Manager, Regulatory Affairs Lorenzweg 5 12099 Berlin GERMANY
Re: K131782
Trade/Device Name: aap LOTEQ® Osteotomy 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 Dated: October 21, 2013 Received: October 23, 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. 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
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Page 2 - Dr. Christian Zietsch
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 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/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/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/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
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aap Implantate AG aap LOQTEQ® Osteotomy System
Indications for Use Statement
510(k) Number (if known): K131782
Device Name: aap LOQTEQ® Osteotomy System
Indications for Use:
The indication for use of the aap LOQTEQ® Osteotomy System are:
LOQTEQ® High Tibial Osteotomy Plate 4.5:
- Open-wedge osteotomies at the proximal medial tibia .
- Treatment of bone and joint deformities .
- Treatment of malpositions caused by injuries or disorders such as . osteoarthritis
LOQTEQ® Distal Femur Osteotomy Plate 4.5:
- Closed-wedge osteotomies of the medial distal femur .
- Treatment of bone and joint deformities .
- Treatment of malpositions caused by injuries or disorders such as . osteoarthritis
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Elizabeth L. Frank -S
Division of Orthopedic Devices
§ 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.