Predicate Devices

K142776, K151146, K161058, K132502, K140769

Reference Devices

K151418, K161292/K162635, K101557, K141493

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related technologies. The device is a mechanical bone screw with fenestrations for bone void filler delivery.

Therapeutic

No

The device is intended for the mechanical fixation of bone fractures and reconstruction, and to deliver bone void fillers, which are structural and delivery functions, not therapeutic.

Diagnostic

No

The device is described as an "Injection Screw" intended for fixation of bone fractures and bone reconstructions, and for delivering injectable bone void fillers. These are therapeutic and structural functions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical bone screw with fenestrations for delivering bone void filler, indicating it is a hardware device, not software.

IVD (In Vitro Diagnostic)

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 "fixation of bone fractures and bone reconstructions of the humerus." This is a surgical procedure performed directly on the patient's body.
Device Description: The device is a "screw" designed to be implanted into bone. It is used in conjunction with plating systems.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples taken from the body, not to directly treat or repair the body itself. This device is clearly a surgical implant used for structural support and bone repair.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MDS Injection Screw is intended for the fixation of bone fractures and bone reconstructions of the humerus. The MDS Injection Screws can be used to deliver injectable bone void fillers to a surgical site and are compatible with applicable MDS plating systems.

Product codes

HWC

Device Description

Miami Device Solutions (MDS) Injection Screws enable fixation of simple and complex fractures of the humerus. The MDS Injection Screws are only to be used in combination with compatible MDS 3.5T plating systems in the humerus (Proximal Humerus Plating System, K141493/K161058; MDS Plating System, K172786). When inserted through a 3.5T plate screw hole, injection screw placement is possible at any angle within a 40° cone. MDS Injection Screws can be used with or without bone void fillers. Fenestrations along the screw length allow bone void filler delivery directly into the surgical site.
Materials: Titanium alloy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

humerus

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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

Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory/performance) testing as well as engineering analysis such as the following for subject devices demonstrate that the device is as safe and as effective as the predicates:

Mechanical Performance Testing -
ASTM F543 Standard Specification and Test Method for Metallic Bone Screws O
Angular Stability O
Fatigue Strength o
BVF Delivery -
Cadaver Lab O
Injectability/Extrudability/Extraction Torque O
BVF Characterization O

Substantial equivalence is demonstrated in the performance testion of the submission by comparing subject and predicate designs. Comparison of the design, intended use, and testing demonstrate that the MDS Injection Screw performs as well as the predicate devices and should thereby be considered substantially equivalent.

Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.

Key Metrics

Not Found

Predicate Device(s)

K142776, K151146, K161058, K132502, K140769

Reference Device(s)

K151418, K161292/K162635, K101557, K141493

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

Summary

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July 13, 2018

Biedermann Medtech, Inc. Michelle Montesino Regulatory Affairs Specialist 7620 NW 25th Street Unit 3 & 4 Miami, Florida 33122

Re: K173556

Trade/Device Name: Injection Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 8, 2018 Received: June 11, 2018

Dear Michelle Montesino:

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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 medical devices and radiation-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,

Vincent J. Devlin -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173556

Device Name Injection Screw

Indications for Use (Describe)

The MDS Injection Screw is intended for the fixation of bone fractures and bone reconstructions of the humerus. The MDS Injection Screws can be used to deliver injectable bone void fillers to a surgical site and are compatible with applicable MDS plating systems.

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
----------------------------------------------	------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitter Name:	Biedermann Medtech, Inc.
Submitter Address:	7620 NW 25th Street, Unit 3 & 4;
Miami, FL 33122
Contact Person:	Michelle Montesino
Phone: (786) 422-1400 Ext. 106
Fax: (786) 422-1401

Reference Devices:

Paragon 28, Inc.; The Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments – K151418

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Miami Device Solutions, LLC; Distal Radius Plating System -K161292/K162635

Etex Corp., Beta-bsm Injectable Bone Substitute Material -K101557

Miami Device Solutions Proximal Humerus Plating System Multiuse Screw - K141493

Device Description:

Miami Device Solutions (MDS) Injection Screws enable fixation of simple and complex fractures of the humerus. The MDS Injection Screws are only to be used in combination with compatible MDS 3.5T plating systems in the humerus (Proximal Humerus Plating System, K141493/K161058; MDS Plating System, K172786). When inserted through a 3.5T plate screw hole, injection screw placement is possible at any angle within a 40° cone. MDS Injection Screws can be used with or without bone void fillers. Fenestrations along the screw length allow bone void filler delivery directly into the surgical site.

Materials: Titanium alloy.

Intended Use:

The MDS Injection Screw is intended for the fixation of bone fractures and bone reconstructions of the humerus. The MDS Injection Screws can be used to deliver injectable bone void fillers to a surgical site and are compatible with applicable MDS plating systems.

Substantial Equivalence Statement:

Documentation is provided which demonstrates that the MDS Injection Screw is equivalent to its predicate in terms of material, design, intended use, and performance characteristics.

Performance Data:

Non-Clinical Performance and Conclusions:

The results of non-clinical (laboratory/performance) testing as well as engineering analysis such as the following for subject devices demonstrate that the device is as safe and as effective as the predicates:

Mechanical Performance Testing -
- ASTM F543 Standard Specification and Test Method for Metallic Bone Screws O
- Angular Stability O
- Fatigue Strength o
BVF Delivery -
- Cadaver Lab O
- Injectability/Extrudability/Extraction Torque O
- BVF Characterization O

Substantial equivalence is demonstrated in the performance testion of the submission by comparing subject and predicate designs. Comparison of the design, intended use, and testing demonstrate that the MDS Injection Screw performs as well as the predicate devices and should thereby be considered substantially equivalent.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Conclusion

The MDS Injection Screw is substantially equivalent to the predicate devices.