SMV Scientific 4.5 mm Bone Screws

K150188 · Summit Medventures · HWC · Apr 29, 2015 · Orthopedic

Device Facts

• Record ID: K150188
• Device Name: SMV Scientific 4.5 mm Bone Screws
• Applicant: Summit Medventures
• Product Code: HWC · Orthopedic
• Decision Date: Apr 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Device Story

SMV Scientific 4.5mm Bone Screws are cortical, self-tapping metallic bone fixation fasteners; used for fracture treatment in various bones including clavicle, scapula, pelvis, long bones, and small bones. Screws are provided non-sterile; manufactured from stainless steel. Device functions as mechanical fixation hardware; implanted by surgeons in clinical settings. Output is physical stabilization of bone fractures; aids in healing process.

Clinical Evidence

Bench testing only. Testing performed per ASTM F543 including static torsion, driving torque, pullout testing, and removal torque. Results demonstrate sufficient strength for intended use.

Technological Characteristics

Stainless steel (ASTM F138); cortical, self-tapping screw design; non-sterile; mechanical fixation fastener; Class II (21 CFR 888.3040).

Indications for Use

Indicated for treatment of fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, fibula), and small bones (metacarpals, metatarsals, phalanges).

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

• Osteo-Plate and Screw Fixation (K092889)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "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

April 29, 2015

Summit MedVentures % Mr. Kenneth C. Maxwell II Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K150188

Trade/Device Name: SMV Scientific 4.5 mm Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 3, 2015 Received: April 6, 2015

Dear Mr. Maxwell:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Kenneth C. Maxwell II

forth in the quality systems (QS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson -S

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 | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| | See PRA Statement on last page. |

**Indications for Use**

| 510(k) Number ( <i>if known</i> ) | K150188 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SMV Scientific 4.5mm Bone Screws |
| Indications for Use ( <i>Describe</i> ) | The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges). |

Type of Use (Select one or both, as applicable)

| <div> <span> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13) PSC Publishing Services [phone] EF

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# 510(K) SUMMARY

| Submitter's Name | SMV Scientific |
|----------------------------------------|------------------------------------------------------------------|
| Submitter's Address | 111 Sandra Muraida Way<br>Unit 18A<br>Austin, TX 78703 |
| Submitter Contact Person | Nephi Zufelt<br>Chief Technology Officer<br>512-750-8622 |
| Empirical Consulting<br>Contact Person | Kenneth C. Maxwell II<br>Empirical Testing Corp.<br>719.291.6874 |
| Date Summary was<br>Prepared | 16 April 2015 |
| Trade or Proprietary Name | SMV Scientific 4.5mm Bone Screw |
| Common or Usual Name | Screw, Fixation, Bone |
| Classification | Class II per 21 CFR §888.3040 Device Classification |
| Product Code | HWC |
| Classification Panel | Division of Orthopedic Devices |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The SMV Scientific 4.5mm Solid Bone Screws consist of cortical screws in a variety of lengths to accommodate different anatomic sizes of patients. The screws are provided non-sterile and are self-tapping. Screws are manufactured from stainless steel.

### INDICATIONS FOR USE

The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges). The indications for the 4.5mm Bone Screw is similar to that of the predicate devices.

## TECHNOLOGICAL CHARACTERISTICS

The SMV Scientific 4.5mm Bone Screw is made from stainless steel that conforms to ASTM F138. The subject and predicate device have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- Indications for Use
- Materials
- Principles of Operation ●

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Table 5-1 Predicate Device

| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|-------------|------------------------------------|--------------|---------|
| K092889 | Osteo-Plate and Screw Fixation | Syntec | Primary |

### PERFORMANCE DATA

The SMV Scientific 4.5mm Bone Screw has been tested in the following test modes:

- Static Torsion per ASTM F543 .
- Driving Torque per ASTM F543 ●
- Pullout Testing per ASTM F543 .
- Removal Torque per ASTM F543 o

The results of this non-clinical testing show that the strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the SMV Scientific 4.5mm Bone Screw is substantially equivalent to the predicate device.