Sonoma Cancellous Bone Screw and Washer

K150376 · Sonoma Orthopedics Products, Inc. · HWC · Jun 12, 2015 · Orthopedic

Device Facts

• Record ID: K150376
• Device Name: Sonoma Cancellous Bone Screw and Washer
• Applicant: Sonoma Orthopedics Products, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

Device Story

Family of stainless steel cancellous bone screws and washers; used for skeletal repairs requiring cancellous thread profiles. Screws available in 4mm to 7.3mm diameters; cannulated and solid configurations. Washers increase bone contact area; prevent screw head subsidence in soft bone. Used by orthopedic surgeons in clinical settings for fracture fixation. Device provides mechanical stabilization of bone fragments. Benefits include secure fixation and reduced risk of hardware migration into bone.

Clinical Evidence

Bench testing only. Engineering analysis and mechanical testing performed according to ASTM F543-13 for torsional properties and axial pullout strength.

Technological Characteristics

Materials: 316 stainless steel per ASTM F138. Dimensions/features conform to ASTM F543-13. Configurations: Cannulated and solid screws (4.0mm to 7.3mm diameters). Mechanical fixation via threaded profile.

Indications for Use

Indicated for fixation of bone fractures appropriate for the screw size; includes use of washers to increase bone contact and prevent subsidence. Contraindicated for posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

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

• Syntec Bone Screws (K983495)

Submission Summary (Full Text)

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June 12, 2015

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

Sonoma Orthopedics Products, Incorporated % Ms. Dawn Norman Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133

Re: K150376

Trade/Device Name: Sonoma Cancellous Bone Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: May 1, 2015 Received: May 5, 2015

Dear Ms. Norman:

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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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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K150376

#### Device Name

Sonoma Cancellous Bone Screws and Washers

#### Indications for Use (Describe)

The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

# 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)

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# 510(k) Summary

Sonoma Cancellous Bone Screw and Washer February 12, 2015

Company: Sonoma Orthopedics Products, Inc 1388 Busch Parkway Buffalo Grove, IL 60089 707-526-1335 Phone: Fax: [phone]

# Establishment

Registration: 3007038372

- Primary Contact: Dawn Norman, MS Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, TN 38133, USA 618-604-3064 Phone: Fax: [phone]
## Company/Secondary Contact:

Kyle Lappin Sonoma Orthopedics Products, Inc 1388 Busch Parkway Buffalo Grove, IL 60089 Phone: [phone] Fax: [phone]

- Trade Name: Sonoma Cancellous Bone Screw and Washer
- Common Name: Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener

Classification: Class II

- Regulation Number: 21 CFR 888.3030; 21 CFR 888.3040
Panel: 87- Orthopedic

Product Code(s): HWC, HTN

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#### Predicate Device(s): K983495 Syntec Bone Screws

- Device Description: Sonoma Cancellous Bone Screws and Washers are a family of stainless steel screws and washers used for various skeletal repairs where cancellous screw thread profiles are clinically desired. The screws are offered in range of diameters from 4mm to 7.3mm, in both cannulated and solid configurations. The screw dimensions including thread profile, thread length, core diameter, cannulation diameter (where applicable), head diameter, overall length, and driving socket size are equivalent to the predicate device. Where applicable, these features are dimensioned as described by ASTM F543-13 (i.e. 4.0mm and 6.5mm solid screws). The washers are sized according to screw diameter and can be used to prevent head subsidence in soft bone. The screws and washers are manufactured from 316 stainless steel per ASTM F138.
- Indications for Use: The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the screw. The washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
- Substantial Equivalence: The intended uses of the subject device are the same as the predicate device. The materials of construction of the subject device are the same as the predicate device. The dimensions of the subject device are equivalent to the dimensions of the predicate device. The indications for use of both the subject and predicate devices are for the fixation of fractured bones. Thus, the subject device is substantially equivalent to the predicate device.
- Performance Testing: Engineering analysis and mechanical testing according to ASTM F543-13 in torsional properties and axial pullout testing demonstrate the subject device is substantially equivalent to the predicate device.