(137 days)
Not Found
No
The device description focuses on the mechanical components (plates, screws, washers) and their material properties and design for bone fixation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies are mechanical tests, not evaluations of algorithmic performance.
Yes
The device is described as a "Plate and Screw System" used for "internal fixation of the bone after fractures, osteotomies or non-unions," which directly addresses and treats a medical condition.
No
Explanation: The device is described as a "Plate and Screw System" used for internal fixation of bones after fractures, osteotomies, or non-unions. It is an implantable medical device used for treatment, not for diagnosing a condition.
No
The device description explicitly details physical components such as bone plates, bone screws, and instruments made of Ti6Al4V, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical fixation of bone fractures, osteotomies, and non-unions of the distal fibula. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device consists of bone plates and screws, which are implanted into the body to provide structural support and stability to bone fragments. This is a medical device used for treatment, not for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
In summary, this device is a surgical implant used for orthopedic fixation, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The aap Plate and Screw System LOQTEQ Distal Fibula Plates consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones. The Distal Fibula Plate System 3.5 is part of the LOQTEQ anatomic plate system. The anatomically preformed plates are available as right and left versions and in different lengths. The tapered end of the plate enables tissue-conserving, submuscular insertion. The 1.8 mm thin anatomic LOQTEQ® Distal Fibula Plate 3.5 prevents skin and soft tissue irritation. All plate holes, with the exception of the oblong hole, are compatible with unidirectional locking screws as well as cortical screws (gold). The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The partially threaded Cancellous Screw dia 4.0 engages the remote bone fragment and slides through the bone fragment near the screw head. Thus, partially threaded screws enable interfragmentary compression. Washers in conjunction with aap screws are used to fixate small bone fragments. The aap Plate and Screw System LOQTEQ Distal Fibula Plates 3.5 incorporates: LOQTEQ Distal Fibula Plate 3.5, right and left ● . LOQTEQ Cortical Screw 3.5, small head, T15, self-tapping . Cortical Screw 3.5, T15, self-tapping ● Cancellous Screw 4.0, small head, T15 ● Washer, I-Ø4.4, A-Ø8.0 ● Set of Instruments LOQTEQ Distal Fibula Plates 3.5 Material: All implants are made of Ti6Al4V (according ISO 5832-3 or ASTM F136) The surface of the plates is generated by an automatic slide finishing, the so-called "KeramoFinish". Those surfaces correspond to polished surfaces. The surface of the LOQTEQ® Cortical Screws are slightly polished and anodised. The surface of the Cortical Screws are fine blasted and anodised as well.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 substantial equivalence of the device.
Summary of Non-clinical tests:
Type of test:
"Mechanical Safety of aap Implantate AG – LOQTEQ" Distal Fibula Plate, Static and Dynamic 4-point-bending test of bone plates according to ASTM F 382-99 (Reapproved 2008)."
"Mechanical properties of metallic bone screws in accordance with ASTM F543-13e1"
"Biocompatibility of Implants and Instruments of aap LOQTEQ Distal Fibula Plates and Screw"
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 screws fulfil the relevant demands of ASTM F543-13.
The implants have successfully passed the tests and have hereby been proven to be mechanically as good as or better than the predicate devices.
Clinical Data were not needed for these devices to show substantial equivalence.
The LOQTEQ® Distal Fibula Plates and Screws has passed all defined criteria, has performed as well or better than the predicate device and are therefore considered substantially equivalent to the cleared predicate device.
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
Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
AAP Implantate Ag Reni Schaller Manager Regulatory Affairs Lorenzweg 5 Berlin, D-12099 Germany
Re: K161703 Trade/Device Name: LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer 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, HTN Dated: September 19, 2016 Received: September 20, 2016
Dear Ms. Schaller:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161703
Device Name
LOQTEQ® Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
Indications for Use (Describe)
Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Traditional Premarket Notification K161703
aap LOQTEQ® Distal Fibula Plates 3.5
Section 5 510(k) Summary
5. 510(k) Summary
(as required by section 807.92)
| (1) | |
|---|---|
| Sponsor: | aap Implantate AG |
| Lorenzweg 5 | |
| D-12099 Berlin, Germany | |
| Company Contact: | Reni Schaller |
| Phone:+49-30-750-19 - 193 | |
| Fax: +49-30-750-19 – 111 | |
| Email: r.schaller@aap.de | |
| Date | |
| (2) | October/27/2016 |
| Trade Name: | LOQTEQ® Distal Fibula Plate 3.5 |
| Cancellous Screw 4.0 | |
| Washer | |
| Common Name: | Distal Fibula Plate and Screw, Cancellous Screw, Washer |
| Classification Name | |
| and Reference: | 21 CFR 888.3030 Single/multiple component metallic bone fixation |
| appliances and accessories - Class II | |
| 21 CFR 888.3040 Smooth or threaded metallic bone fixation | |
| fastener - Class II | |
| Device Product Code & | |
| Panel Code: | Orthopedics/87/HRS |
| Orthopedics/87/HWC | |
| Orthopedics/87/HTN | |
| (3) | |
| Predicate devices | → LOQTEQ® 1/3 Tubular Plate 3.5 under the premarket notification |
| K113652 (LOQTEQ ® Small Fragment Set) | |
| →Cancellous Screw 4.0 under the premarket notification K072411 | |
| → Washer under the premarket notification K990776 | |
| (4) | |
| Device Description: | The aap Plate and Screw System LOQTEQ Distal Fibula Plates |
| consists of bone plates and bone screws, to be implanted by a | |
| surgeon in order to achieve a repositioning of fragments and an | |
| internal fixation of the bone after fractures, osteotomies or non- | |
| unions. By using locking screws the plate screw system guarantees | |
| an additional mechanical fixation and enables the application for | |
| osteopenic bones. | |
| The Distal Fibula Plate System 3.5 is part of the LOQTEQ anatomic | |
| plate system. The anatomically preformed plates are available as | |
| right and left versions and in different lengths. | |
| The tapered end of the plate enables tissue-conserving, submuscular | |
| insertion. | |
| The 1.8 mm thin anatomic LOQTEQ ® Distal Fibula Plate 3.5 prevents | |
| skin and soft tissue irritation. | |
| All plate holes, with the exception of the oblong hole, are | |
| compatible with unidirectional locking screws as well as cortical | |
| screws (gold). The use of locking screws is state of the art and is | |
| particularly important in osteoporotic bones or for stabilizing | |
| comminuted fractures. The elongated hole can be used to adjust the | |
| height as well as the initial fixation of the plate. | |
| The partially threaded Cancellous Screw dia 4.0 engages the remote |
The partially threaded Cancellous Screw dia 4.0 engages the remote bone fragment and slides through the bone fragment near the screw
4
head. Thus, partially threaded screws enable interfragmentary compression. Washers in conjunction with aap screws are used to fixate small bone fragments. The aap Plate and Screw System LOQTEQ Distal Fibula Plates 3.5 incorporates: LOQTEQ Distal Fibula Plate 3.5, right and left ● . LOQTEQ Cortical Screw 3.5, small head, T15, self-tapping . Cortical Screw 3.5, T15, self-tapping ● Cancellous Screw 4.0, small head, T15 ● Washer, I-Ø4.4, A-Ø8.0 ● Set of Instruments LOQTEQ Distal Fibula Plates 3.5 Material: All implants are made of Ti6Al4V (according ISO 5832-3 or ASTM F136) The surface of the plates is generated by an automatic slide Surface: finishing, the so-called "KeramoFinish". Those surfaces correspond to polished surfaces. The surface of the LOQTEQ® Cortical Screws are slightly polished and anodised. The surface of the Cortical Screws are fine blasted and anodised as well. (5) Fractures, osteotomies and non-unions of the distal fibula, Indications: particularly in osteopenic bone. (6) The LOQTEQ® Distal Fibula Plate and the legally marketed Technological predicated devices have similar indications, dimensions, geometry characteristics and materials. Comparison The LOQTEQ® Distal Fibula Plate is technologically substantially equivalent to the predicate devices according to the Decision-Making Process for 510(k)s: 1. Predicate device is legally marketed 2. The devices have the identical intended use 3. The devices have the same technological characteristics All characteristics which are known and are relevant for the safety for both devices are described and assessed mainly: 1.Indication for use statement: identical 2. Functionality: identical 3. Components, Materials, Dimensions of components: comparable 4. Mechanical properties (ensured by benchmark tests) at least comparable Documentation including mechanical testing to show the substantial equivalence has been provided with this submission.
5
510(k) Traditional Premarket Notification K161703 aap LOQTEQ® Distal Fibula Plates 3.5 Section 5 510(k) Summary
(ep)
Performance Data (Non-Clinical and / or Clinical):
Non-clinical tests have been performed and show the substantial equivalence of the device.
Summary of Non-clinical tests:
Type of test:
"Mechanical Safety of aap Implantate AG – LOQTEQ" Distal Fibula Plate, Static and Dynamic 4-point-bending test of bone plates according to ASTM F 382-99 (Reapproved 2008)."
"Mechanical properties of metallic bone screws in accordance with ASTM F543-13e1"
"Biocompatibility of Implants and Instruments of aap LOQTEQ Distal Fibula Plates and Screw"
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 screws fulfil the relevant demands of ASTM F543-13.
The implants have successfully passed the tests and have hereby been proven to be mechanically as good as or better than the predicate devices.
Clinical Data were not needed for these devices to show substantial equivalence.
The LOQTEQ® Distal Fibula Plates and Screws has passed all defined criteria, has performed as well or better than the predicate device and are therefore considered substantially equivalent to the cleared predicate device.