Injection Screw

K173556 · Biedermann Medtech, Inc. · HWC · Jul 13, 2018 · Orthopedic

Device Facts

• Record ID: K173556
• Device Name: Injection Screw
• Applicant: Biedermann Medtech, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Injection screw for fixation of humerus fractures and reconstructions; used in conjunction with compatible MDS 3.5T plating systems. Device features fenestrations along its length to allow delivery of injectable bone void fillers directly to the surgical site. Inserted through plate screw holes with 40-degree angular range. Operated by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization of bone segments; facilitates targeted delivery of bone void fillers to promote healing. Benefits include combined fixation and bone graft delivery in a single procedure.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical laboratory performance testing, including mechanical testing (ASTM F543, fatigue, angular stability) and BVF delivery characterization (injectability, extrudability, extraction torque) in a cadaver model.

Technological Characteristics

Material: Titanium alloy. Design: Fenestrated bone screw for fixation and bone void filler delivery. Compatibility: MDS 3.5T plating systems. Mechanical standards: ASTM F543. Operational range: 40-degree cone angular stability.

Indications for Use

Indicated for fixation of bone fractures and bone reconstructions of the humerus in patients requiring surgical stabilization and/or delivery of injectable bone void fillers.

Regulatory Classification

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.

Predicate Devices

• Flow-Fx Flow-Screw (K142776)
• N-Force Fixation System (K151146)
• Miami Device Solutions Cannulated Screw (K161058)
• Variax 2 System Bone Screws (K132502, K140769)

Reference Devices

• The Monster Screw System (K151418)
• Distal Radius Plating System (K161292/K162635)
• Beta-bsm Injectable Bone Substitute Material (K101557)
• Miami Device Solutions Proximal Humerus Plating System Multiuse Screw (K141493)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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;<br>Miami, FL 33122 | | | | | | | | | | | | | | | | |
| Contact Person: | Michelle Montesino<br>Phone: [phone] Ext. 106<br>Fax: [phone]<br><br>Anderson Giraldo<br>Phone: [phone] Ext 115<br>Fax: [phone] | | | | | | | | | | | | | | | | |
| Date of Submission: | 07/12/2018 | | | | | | | | | | | | | | | | |
| Manufacturer Name: | Biedermann Medtech, Inc. | | | | | | | | | | | | | | | | |
| Manufacturer Address: | 7620 NW 25th Street, Unit 3 & 4;<br>Miami, FL 33122 | | | | | | | | | | | | | | | | |
| Registration Number: | 3013248720 | | | | | | | | | | | | | | | | |
| Contact Name: | Markku Biedermann | | | | | | | | | | | | | | | | |
| Title: | Chairman | | | | | | | | | | | | | | | | |
| Device Trade Name: | Injection Screw | | | | | | | | | | | | | | | | |
| Device Common Name: | Primary: Screw, Fixation, Bone | | | | | | | | | | | | | | | | |
| Classification Names: | Primary: Screw, Fixation, Bone | | | | | | | | | | | | | | | | |
| Classification Code: | Primary: HWC – Class II | | | | | | | | | | | | | | | | |
| Classification Panel: | Orthopedic | | | | | | | | | | | | | | | | |
| Regulation Number: | Primary: 21 CFR section 888.3040 – Smooth or threaded metallic<br>bone fixation fastener | | | | | | | | | | | | | | | | |
| Predicate Device: | Primary K142776 Flow-Fx Flow-Screw Secondary K151146 N-Force Fixation System Secondary K161058 Miami Device Solutions Cannulated<br>Screw Secondary K132502,<br>K140769 Variax 2 System Bone Screws | | | | | | | | | | | | | | | | |

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.