PARCUS PPEK CF INTERFERENCE SCREW

K091093 · Parcus Medical, LLC · HWC · Sep 30, 2009 · Orthopedic

Device Facts

• Record ID: K091093
• Device Name: PARCUS PPEK CF INTERFERENCE SCREW
• Applicant: Parcus Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Sep 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Parcus PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Device Story

Parcus PEEK CF Interference Screw is a cannulated, tapered fastener used for interference fixation of ligaments and tendons. Device is manufactured from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). Available in diameters 7-12mm and lengths 20-35mm. Used by surgeons in orthopedic procedures to secure soft tissue grafts. Device functions as a mechanical fastener to hold tissue in place during healing. Performance validated via bench testing comparing pull-out strength and insertion torque against titanium predicate devices.

Clinical Evidence

Bench testing only. Pull-out strength and insertion torque measured for 7mm, 12mm, and intermediate sizes. Results compared to Parcus Titanium Interference Screws demonstrated substantial equivalence.

Technological Characteristics

Cannulated, tapered interference screw. Material: Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). Dimensions: 7-12mm diameter, 20-35mm length. Mechanical fixation principle.

Indications for Use

Indicated for fixation of ligaments and tendons in patients requiring ligament or tendon repair.

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

• Parcus Titanium Interference Screws (K083619)
• Smith & Nephew PEEK Interference Screws (K083226)

Reference Devices

• Zimmer Spine BAK Vista Radiolucent Interbody Fusion System
• Depuy Spine OCELOT Stackable Cage System

Submission Summary (Full Text)

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K091093 P142

# Medical, LLC

SURGICAL INNOVATION >> VALUE DRIVEN

# SEP 3.0 2009

#### 510(k) Summary

| Submitter: | Parcus Medical, LLC<br>839 South Neenah Ave.<br>Sturgeon Bay, WI 54234 |
|----------------------|-----------------------------------------------------------------------------------------------|
| Company Contact: | Barton Bracy<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 13, 2009 |
| Trade Name: | Parcus PEEK CF Interference Screw |
| Common Name: | Interference Screw |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue<br>21 CFR 888.3040 - Product Code HWC and MBI |

#### Predicate Devices:

- . Parcus Titanium Interference Screws (K083619)
- Smith & Nephew PEEK Interference Screws (K083226) .

## Device Description:

The Parcus PEEK CF Interference Screw is a cannulated, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.

#### Intended Use:

The Parcus PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

### Substantial Equivalence Summary:

The Parcus PEEK CF Interference Screws are essentially the same as the Parcus Titanium Interference Screws aside from the difference in material.

The only difference between the materials for the Parcus PEEK CF Interference Screw and the Smith & Nephew PEEK Interference Screw is that the Parcus Interference Screw is carbon reinforced. Carbon fibers have been used clinically for more than 20 years as a reinforcement component for implant materials without obvious leachable-related biocompatibility reactions.

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839 S NEENAH AVE., STURGEON BAY, WI 54235

>> 1-877-746-2972

>> www.parcusmedical.com

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Image /page/1/Picture/1 description: The image shows the logo for PARCUS Medical, LLC. The word "PARCUS" is in large, bold, black letters. To the right of the word "PARCUS" is the text "Medical, LLC" in a smaller font size.

SURGICAL INNOVATION >> VALUE DRIVEN

Furthermore, there are currently several medical device implants on the market made from PEEK CF (e.g. Zimmer Spine BAK® Vista® Radiolucent Interbody Fusion System and the Depuy Spine OCELOT™ Stackable Cage System).

Therefore the Parcus PEEK CF Interference Screw is substantially equivalent to the predicate devices listed above in which the basic features and intended uses are the same. Any differences between the PEEK CF Interference Screw and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness.

#### Summary Performance Data:

The pull out strength and insertion torque was measured for the smallest (7mm) and largest (12mm) Parcus PEEK CF Interference Screws as well as an intermediate size. Test results were compared to the results of the corresponding size of Parcus Titanium Interference Screws and demonstrated substantial equivalence.

#### Page 16 of 154

839 S NEENAH AVE., STURGEON BAY, WI 54235

>> 1-877-746-2972

>> www.parcusmedical.com

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized depiction of a bird or eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

SEP 30 2009

Parcus Medical, LLC c/o Mr. Barton Bracy VP Marketing and Product Development 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54235

Re: K091093

Trade/Device Name: Parcus PEEK CF Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: September 23, 2009 Received: September 30, 2000

Dear Mr. Bracy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Barton Bracy

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 M Milliken

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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Indications for Use

510(k) Number (if known): _ Koq1093

Device Name: _ Parcus PEEK CF Interference Screw

### Indications for Use:

The Parcus PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

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 IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K091093

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