(89 days)
The OSTEOMED ExtremiLOCK Ankle Plating System is intended for fixation of fractures, and non-unions of the tibia and fibula as well as arthrodesis of the ankle including Tibiotalocalcaneal joint. The ExtremiLOCK Ankle Plating System implants are intended for single use only.
The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.
The OSTEOMED ExtremiLOCK Ankle Plating System can be used for adult and adolescent (greater than 12-21 years of age) patients.
The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are a line extension to be included in the OsteoMed ExtremiLOCK Ankle Plating System (previously cleared for market in premarket notification K133691). The OsteoMed ExtremiLOCK Ankle Plating System provides a comprehensive solution for ankle fractures and ankle fusion management. The OsteoMed ExtremiLOCK Ankle Plating System plates, screws, washers and instrumentation are contained in a single instrument tray. The system instrumentation is used to facilitate placement, screw insertion and/or removal of implants.
The OsteoMed ExtremiLock Lateral Ankle Fusion Plates are designed for use in Tibiotalar (TT) and Tibiotalocalcaneal (TTC) arthrodesis procedures through a lateral transfibular approach. The plates feature universal holes that accept angulated locking and standard non-locking 3.5mm and 4.0mm screws and 4.0mm fully threaded cannulated double lead screws. The TT and TTC plates have been designed to optimize compression, strength, and construct stability by providing up to 5 points of fixation in the tibia, talus and calcaneus. The innovative plate design, rounded edges and highly polished surface allows for reduced dissection of soft tissue structures and minimizes soft tissue irritation. Both plates offer multiple compression hole options including oblong holes, transfixation holes, and an anatomic transfixation 5.5mm lag screw compression hole. The 5.5mm transfixation lag screw hole is designed to cross the arthrodesis site within the plate maximizing uniform axial compression across the joint and capturing the medial tibial side.
The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are made from commercially pure titanium grade 4 (ASTM F67). The plates are intended for single use only.
The provided text describes a 510(k) premarket notification for the "OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates." This submission is for a medical device that is a metallic bone fixation appliance, not an AI/ML powered device. As such, the acceptance criteria and study information typically associated with AI/ML device evaluations (e.g., test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or detailed in this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing rather than clinical or AI performance studies.
Here's a breakdown of the available information based on the questions, with an emphasis that this is not an AI/ML device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Mechanical strength criteria for intended use | Plates met required mechanical strength criteria. Evaluation performed by cyclic 4-point bending and static 4-point bending tests in accordance with Annex A1 of ASTM F382-17. Performance equivalence was shown through verification comparison to the predicate device (Normed/Zimmer Ankle Fix 4.0, K123347). |
| Biocompatibility | Plates are manufactured from commercially pure titanium grade 4 (ASTM F67), which is stated to be biocompatible, the same material as the additional predicate device (OsteoMed ExtremiLOCK Ankle Plating System, K133691). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The evaluation was primarily bench testing of physical devices, not data-driven analysis from a test set of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. "Ground truth" in the context of AI/ML algorithms, derived from expert review of medical data, is not relevant to this device's evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used for resolving disagreements among experts when establishing ground truth for AI/ML performance evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. An MRMC study is relevant for evaluating the impact of AI assistance on human performance, which is not the subject of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. "Standalone performance" refers to the performance of an AI algorithm without human involvement, which is not relevant for this physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. The "ground truth" for this device would relate to its structural integrity and material properties, confirmed by engineering standards and bench testing, not clinical diagnoses or outcomes data in the sense of AI/ML evaluation.
8. The sample size for the training set
This information is not applicable and not provided. Training sets are used for developing AI/ML algorithms.
9. How the ground truth for the training set was established
This information is not applicable and not provided. Training sets and their associated ground truth are specific to AI/ML development.
In summary: The provided document details a 510(k) submission for a metallic bone fixation device, not an AI/ML product. Therefore, the evaluation criteria and study methods are based on mechanical bench testing and material biocompatibility, focusing on demonstrating substantial equivalence to predicate devices, rather than the performance metrics and study designs used for AI/ML medical devices.
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February 24, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OsteoMed Andrew Johnson Senior Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001
Re: K203479
Trade/Device Name: ExtremiLOCK Lateral Ankle Fusion Plates 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: November 25, 2020 Received: November 27, 2020
Dear Andrew Johnson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203479
Device Name
OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates
Indications for Use (Describe)
The OSTEOMED ExtremiLOCK Ankle Plating System is intended for fixation of fractures, and non-unions of the tibia and fibula as well as arthrodesis of the ankle including Tibiotalocalcaneal joint. The ExtremiLOCK Ankle Plating System implants are intended for single use only.
The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.
The OSTEOMED ExtremiLOCK Ankle Plating System can be used for adult and adolescent (greater than 12-21 years of age) patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for OsteoMed. The logo is in a stylized oval shape, with the word "OSTEOMED" in blue and gray lettering. The top half of the oval is blue, and the bottom half is gray. There is a registered trademark symbol in the upper right corner of the logo.
510(k) SUMMARY
I. SUBMITTER
OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA Phone: 972-677-4795 Fax: 972-677-4601 Email: djohnson@osteomed.com Contact Person: Andrew "Drew" Johnson November 25, 2020 Date Prepared:
II. DEVICE
| Name of the Device: | OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates |
|---|---|
| Common or Usual Name: | Plate, Fixation, Bone (Primary) and Screw, Fixation, Bone, & Washer |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories (Primary) and Smooth or threaded metallic bone fixation fastener |
| Regulation: | 888.3030 (Primary) & 888.3040 |
| Regulatory Class: | II |
| Product Code: | HRS (Primary) & HWC & HTN |
III. PREDICATE DEVICES
Predicate Device: Normed/Zimmer Ankle Fix 4.0, K123347
Additional Predicate: OsteoMed ExtremiLOCK Ankle Plating System, K133691
IV. DEVICE DESCRIPTION
The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are a line extension to be included in the OsteoMed ExtremiLOCK Ankle Plating System (previously cleared for market in premarket notification K133691). The OsteoMed ExtremiLOCK Ankle Plating System provides a comprehensive solution for ankle fractures and ankle fusion management. The OsteoMed ExtremiLOCK Ankle Plating System plates, screws, washers and instrumentation are contained in a single instrument
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Image /page/4/Picture/1 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in a bold, sans-serif font. The word is in blue, and the bottom half of the word is in gray. The logo is surrounded by a blue and gray oval shape.
tray. The system instrumentation is used to facilitate placement, screw insertion and/or removal of implants.
The OsteoMed ExtremiLock Lateral Ankle Fusion Plates are designed for use in Tibiotalar (TT) and Tibiotalocalcaneal (TTC) arthrodesis procedures through a lateral transfibular approach. The plates feature universal holes that accept angulated locking and standard non-locking 3.5mm and 4.0mm screws and 4.0mm fully threaded cannulated double lead screws. The TT and TTC plates have been designed to optimize compression, strength, and construct stability by providing up to 5 points of fixation in the tibia, talus and calcaneus. The innovative plate design, rounded edges and highly polished surface allows for reduced dissection of soft tissue structures and minimizes soft tissue irritation. Both plates offer multiple compression hole options including oblong holes, transfixation holes, and an anatomic transfixation 5.5mm lag screw compression hole. The 5.5mm transfixation lag screw hole is designed to cross the arthrodesis site within the plate maximizing uniform axial compression across the joint and capturing the medial tibial side.
The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are made from commercially pure titanium grade 4 (ASTM F67). The plates are intended for single use only.
V. INDICATIONS FOR USE
The OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the tibia and fibula as well as arthrodesis of the ankle including Tibiotalar and Tibiotalocalcaneal joint. The ExtremiLOCK Ankle Plating System implants are intended for single use only.
The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and adolescent (greater than 12-21 years of age) patients.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the subject device, OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates, and the predicate device use the same fundamental scientific technology. Both devices have similar indications for use and are intended for internal fixation and reconstruction or arthrodesis of the Tibiotalar and Tibiotalocalcaneal bones of the ankle. The subject and predicate devices provide compression through holes or slots and are anatomically designed to proper screw positioning.
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Image /page/5/Picture/1 description: The image is a logo for OsteoMed. The logo is in an oval shape with the word "OsteoMed" in blue and gray letters. The top half of the oval is blue, and the bottom half is gray. There is a registered trademark symbol in the upper right corner of the logo.
The subject device incorporates a similar basic design as compared to the predicate and additional predicate devices. The subject and predicate devices both have compression, locking, and non-locking screw holes or slots and have holes for Kwires. The plate length, width, and thickness of the subject device falls within the ranges for the additional predicate device. The subject and additional predicate devices can be used with similar screw types and diameters and both have variable angle locking screw orientation.
The subject device's plates are manufactured from titanium (ASTM F-67), the same material used in the manufacture of the additional predicate device. This material is biocompatible.
SUMMARY OF NON-CLINICAL TESTING
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
The evaluation performed (Design performance - bench testing) demonstrates that the OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are comparable to the predicate device cleared under K123347 and additional predicate device cleared under K133691. The plates underwent verification evaluation (cyclic 4-point bending and static 4-point bending tests were conducted in accordance with Annex A1 of ASTM F382-17) to ensure that the design features met the required mechanical strength criteria for their intended use.
Performance equivalence was shown through the verification comparison to the predicate device.
Clinical testing is not required to support substantial equivalence.
CONCLUSIONS VII.
The conclusions drawn from the nonclinical tests demonstrate that the OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are as safe, as effective, and perform as well as or better than the legally marketed device. Normed/Zimmer ANKLE FIX and ANKLE Fix Plus (K123347) under regulation 21 CFR 880.3030 (Primary) and 21 CFR 888.3040, product codes HRS (Primary), HWC and HTN.
(End of Summary)
§ 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.