PMT BONE SCREWS

K121713 · Providence Medical Technology, Inc. · HWC · Sep 27, 2012 · Orthopedic

Device Facts

• Record ID: K121713
• Device Name: PMT BONE SCREWS
• Applicant: Providence Medical Technology, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.

Device Story

PMT Bone Screws are metallic orthopedic fixation devices used by surgeons in clinical settings for bone reconstruction, osteotomy, arthrodesis, joint fusion, and fracture repair. Manufactured from titanium alloy, the screws are available in headed or headless configurations with various diameters and lengths. The device is implanted by a surgeon to provide mechanical stabilization of bone segments. It is intended for single use only. The device functions as a mechanical fastener to maintain bone alignment during the healing process, thereby facilitating patient recovery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Titanium alloy. Form factor: Headed or headless screws in various diameters and lengths. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation in patients requiring bone fixation, appropriate for device size.

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

• Wright Compression Screws (K082320)
• ORTHOLOC Bone Screws (K112772)

Submission Summary (Full Text)

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Providence Medical Technology, Inc.

Section 5. 510(k) Summary

# PMT Bone Screws K121713 ( 1/2)

SEP 27 2012

| 510(k) Owner: | Providence Medical Technology, Inc. |
|-----------------------------------|-------------------------------------|
| | 201 Spear Street, Suite 1310 |
| | San Francisco, CA. 94105 |
| | T: 415-923-9376 |
| | F: 415-923-9377 |
| Contact Person: | Glen Mangseth |
| | [e-mail] |
| | T: 415-923-9376 |
| Date Summary Prepared: | June 10, 2012 |
| Trade Name: | PMT Bone Screws |
| Common Name: | Bone Screw |
| Device Classification Regulation: | 21 CFR 888.3040 - Class II |
| Device Product Code & Panel: | HWC: Screw, Fixation Bone |
| | 87, Orthopedics |
| Predicate Device: | Wright Compression Screws (K082320) |
| | ORTHOLOC Bone Screws (K112772) |

#### Device Information

#### A. Intended Use

The PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.

#### B. Device Description

The design features of the PMT Bone Screws are described below.

- Manufactured from Titanium Alloy .
- Available headed or headless ●
- Available in various diameters and lengths .

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PMT Bone Screws
K 121713 (2/2)

### C. Substantial Equivalence Information

י

:

The design features, material, and indications for use of the PMT Bone Screws are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the PMT Bone Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 27 2012

Providence Medical Technology, Incorporation % Mr. Glen Mangseth Quality Systems Manager 201 Spear Street, Suite 1310 San Francisco, California 94105

Re: K121713

Trade/Device Name: PMT 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: August 20, 2012 Received: August 20, 2012

Dear Mr. Mangseth:

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

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## Page 2 - Mr. Glen Mangseth

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section 4. Indications for Use Statement

# Indications for Use Form (Text Version)

Indications for Use

510(k) Number (if known):

· Device Name: PMT Bone Screws

Indications for Use:

PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashb

Page 1 of 1

(Division Sign-Cil) Division of Surgual. Orthopedic, and Restorative Devices

×1273 510(k) Number .