(236 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes.
The device is used for internal fixation of bone fractures, fusions, non-unions, and other musculoskeletal conditions to aid in healing, which constitutes a therapeutic purpose.
No
Explanation: The device is described as a bone plate system for internal fixation of fractures and other bone conditions. Its purpose is to provide structural support, not to diagnose medical conditions, and there's no mention of diagnostic capabilities like imaging or AI-based analysis.
No
The device description explicitly states it consists of physical components (Bone Plates and locking screw components) made of titanium, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for internal fixation of bone fractures, fusions, osteotomies, etc. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of bone plates and screws, which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The MLP Special Locking Bone Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.
Product codes
HRS, HWC
Device Description
The MLP Special Locking Bone Plate System consists of Bone Plates and locking screw components that are intended to be used in various bone fixation procedures.
The MLP Special Locking Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium (Ti-6Al-4V) in conformance with ASTM F136. Plates and screws are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal
Indicated Patient Age Range
pediatrics and adult populations
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
The Non-clinical tests performed and the Recognized Consensus Standards to which the MLP Special Locking Bone Plate System has been tested are specifically the following:
ASTM F382-17 Static and Dynamic 4-Point Plate Bending Tests (Annex 1, 2 and 3) Specification and Test Method for Metallic Bone Plates
ASTM F543-17 Screw, Pull-Out tests, Torque tests and Torsion tests Specification and Test Methods for Metallic Medical Bone Screws
The results of these evaluations indicate that the MLP Special Locking Plate System is equivalent to the predicate devices.
No clinical Testing was conducted for the subject device.
Key Metrics
Not Found
Predicate Device(s)
K063460, K090047, K163293, K083286, K011335
Reference Device(s)
No reference devices were used in this submission.
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
March 4, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
Maxxion Medical, LLC / Baumer SA % Larry Petersen President Medical Products International 4241 Wildwood Landing North Charleston, South Carolina 29420
Re: K181843
Trade/Device Name: MLP Special Locking Bone Plate 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. HWC Dated: January 11, 2019 Received: January 23, 2019
Dear Larry Petersen:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181843
Device Name
MLP Special Locking Bone Plate System
Indications for Use (Describe)
The MLP Special Locking Bone Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
Maxxion
510(K) SUMMARY
This 510(k) Summary is herewith being submitted in accordance with the requirements of §21 CFR Part 807.92 for the MLP Special Locking Plate System device.
DATE PREPARED: February 26, 2019
- Submitter 807.92(a)(1) l.
APPLICANT'S NAME AND ADDRESS:
Maxxion Medical, LLC 201 South Biscayne Boulevard, Suite 1200 Miami, FL, 33131 USA Phone: +1(305) 704-3500 Email: baumer@baumer.com.br
FDA Organization Number: 499884
APPLICANT'S CONTACT PERSON:
Mr. Larry Petersen Requlatory Affairs Consultant 4241 Wildwood Landing North Charleston, SC 29420 USA Phone: 1-843-832-3232 Email: Larrypetersen7@gmail.com
ll. DEVICE NAME
Trade Name: MLP Special Locking Bone Plate System
Common Name: Single / Multiple component metallic bone fixation appliances, screws and accessories.
4
Classification Name: § §21 CFR 888.3030
Single / Multiple component metallic bone fixation appliances and accessories
Product Codes: HRS, HWC
lll. Predicate Devices 807.92(a)(3)
Legally marketed devices to which we are claiming "Substantial Equivalence" are the following:
-
- K063460 Acumed Bone Implant Plate (Primary Predicate)
-
- K090047 Synthes US, Bone Implant Plate
-
- K163293 In2Bones Colink™ Plating System
-
- K083286 OrthoPediatrics PediLoc Locking Plate System
-
- K011335 Synthes one-third tubular DCL Plate
No reference devices were used in this submission.
Device Description 807.92(a) (4) IV.
The MLP Special Locking Bone Plate System consists of Bone Plates and locking screw components that are intended to be used in various bone fixation procedures.
The MLP Special Locking Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium (Ti-6Al-4V) in conformance with ASTM F136. Plates and screws are provided non-sterile.
V. Statement of Indications for Use of the Device 807.92(a)(5)
Indications for Use
The MLP Special Locking Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.
VI. Comparison of Technological Characteristics with the predicate device 807.92(a)(6)
The technological principle of operation of the subject and predicate devices are
5
fundamentally the same. The indications for use are similar between the subject and predicate devices.
The subject device is made out of titanium as per ASTM F136. The predicates devices use the similar titanium alloy materials per conformance standards, but also offer implants manufactured from stainless steel materials.
Predicates K163293 and K083286 include pediatric indications as does the subject device.
The subject bone plates and screws offer a wide array of various sizes, shapes, thicknesses, curves, and hole configurations. These are all in a similar range to the matching corresponding plates of the predicates.
PERFORMANCE DATA VII. 807.92(b)
807.92(b) (1) Brief Discussion of Non-Clinical Tests Submitted:
The Non-clinical tests performed and the Recognized Consensus Standards to which the MLP Special Locking Bone Plate System has been tested are specifically the following:
ASTM F382-17 Static and Dynamic 4-Point Plate Bending Tests (Annex 1, 2 and 3) Specification and Test Method for Metallic Bone Plates
ASTM F543-17 Screw, Pull-Out tests, Torque tests and Torsion tests Specification and Test Methods for Metallic Medical Bone Screws
The results of these evaluations indicate that the MLP Special Locking Plate System is equivalent to the predicate devices.
Clinical Testing: 807.92(b) (2)
No clinical Testing was conducted for the subject device.
VIII. CONCLUSIONS 807.92(b) (3)
The appropriate Mechanical and Biocompatibility testing that was completed successfully, and a comparison to the predicate devices, clearly demonstrates that the MLP Special Locking Plate System has the same intended use and similar technological characteristics. The device performs as intended and does not raise any new safety or effectiveness issues, and is therefore substantially equivalent to the predicate devices.