SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW

K111230 · Synthes (USA) Products, LLC · HWC · May 24, 2011 · Orthopedic

Device Facts

• Record ID: K111230
• Device Name: SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
• Applicant: Synthes (USA) Products, LLC
• Product Code: HWC · Orthopedic
• Decision Date: May 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes 3.5mm Low Profile Cortical Screws are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur, and fibula in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.

Device Story

Self-tapping, metallic bone fixation screws; available with stardrive or hexdrive recess; lengths 10mm-110mm. Manufactured from stainless steel and titanium; offered sterile or non-sterile. Designed with low-profile head to minimize hardware prominence and soft tissue irritation. Used by surgeons for fracture fixation, osteotomies, and non-unions in various long and flat bones. Can be used independently or with compatible Synthes plates. Provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

Bench testing only. Geometric cross-sectional analysis was performed to compare the subject device to the predicate device, supporting substantial equivalence.

Technological Characteristics

Materials: Stainless steel and titanium. Design: Self-tapping, low-profile head, stardrive or hexdrive recess. Dimensions: 10mm-110mm lengths. Mechanical fixation device. No software or energy source.

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur, and fibula in adults, children (2-12 years), and adolescents (12-21 years) where growth plates are fused or will not be crossed by fixation.

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

• Synthes 3.5mm Cortex Screws (K043185)

Submission Summary (Full Text)

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K11/236

# MAY 2 4 2011

### Attachment 1: Revised 510(k) Summary

| Sponsor: | Synthes (USA)<br>Rebecca Blank<br>Associate Regulatory Affairs Specialist<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone]<br>FAX [phone] |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 29, 2011 |

Synthes 3.5mm Low Profile Cortical Screw

Class 11, § 888.3040 - Smooth or Threaded Metallic Bone Fixation Classification: Fastener Product Code: HWC

Synthes 3.5mm Cortex Screws (K043185) Predicate

Device(s):

Device Name:

- The 3.5mm Low Profile Cortical Screws are self-tapping, have Device Description: either a stardrive or hexdrive recess, are manufactured from stainless steel and titanium and offered both sterile and non sterile. The self-tapping screws are available in lengths ranging from 10mm - 110mm and may be used independently or with any Synthes plate which accepts Synthes 3.5mm cortical screws. The low profile screw head is designed to minimize hardware prominence and the resultant potential for soft tissue irritation.
- Intended Use: The Synthes 3.5mm Low Profile Cortical Screws are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur, and fibula in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.

Information presented supports substantial equivalence of the Substantial Synthes 3.5mm Low Profile Cortical Screw to the predicate Equivalence: devices. The proposed low profile screw has similar indications for use, is similar in design, incorporates the same fundamental product technology and is composed of the same materials.

> To additionally support substantial equivalence, geometric cross sectional analysis was conducted to compare the subject device to the predicate device with results supporting substantial equivalence.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

Synthes (USA) % Ms. Rebecca Blank Associate Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

MAY 2 4 2011

Re: K111230

Trade/Device Name: Synthes (USA) 3.5 mm Low Profile Cortical Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 29, 2011 Received: May 2, 2011

Dear Ms. Blank:

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 - Ms. Rebecca Blank

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/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Euis Keith

for

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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#### Attachment 2: Revised Indications for Use

510(k) Number (if known):

广川|230

Synthes (USA) 3.5mm Low Profile Cortical Screw Device Name:

Indications for Use:

The Synthes 3.5mm Low Profile Cortical Screws are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur, and fibula in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E.L. Keith

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111230

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