PARCUS PEEK CF PUSH-IN SUTURE ANCHOR

K102162 · Parcus Medical, LLC · HWC · Nov 10, 2010 · Orthopedic

Device Facts

• Record ID: K102162
• Device Name: PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
• Applicant: Parcus Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Nov 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Parcus PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, lliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. Hip Acetabular Labral Repair (3.0mm only)

Device Story

Parcus PEEK CF Push-In Suture Anchors are tapered, barbed fasteners designed for soft tissue-to-bone attachment. Device is inserted into prepared bone holes; barbs provide mechanical fixation. Used by surgeons in orthopedic procedures (shoulder, knee, foot/ankle, elbow, hand/wrist, hip). Input is manual surgical placement; output is secure tissue fixation. Benefits include stable reattachment of ligaments and tendons to bone, facilitating healing. Device is provided sterile.

Clinical Evidence

Bench testing only. Pull-out strength testing was performed on the subject device and compared to predicate devices (Parcus V-LoX PEEK CF and Smith & Nephew BioRaptor 2.9). Results demonstrated substantial equivalence in mechanical performance.

Technological Characteristics

Materials: Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). Form factor: Tapered, barbed push-in anchors in 3.0mm and 4.5mm diameters. Sterilization: Provided sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring soft tissue to bone attachment in shoulder, knee, foot/ankle, elbow, hand/wrist, and hip (3.0mm only) procedures, including ligament, tendon, and labral repairs.

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 V-LoX PEEK CF Suture Anchor (K091094)
• Smith & Nephew BioRaptor 2.9 (K031685, K053344)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for PARCUS Medical, LLC. The logo is black and white and features the word "PARCUS" in large, bold letters. To the right of the logo is the text "Medical, LLC" in a smaller font. Above the logo is the text "K102162".

SURGICAL INNOVATION >> VALUE DRIVEN

NO.V. 1 0 2010

#### 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: | July 23, 2010 |
| Trade Name: | Parcus PEEK CF Push-In Suture Anchors |
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue<br>21 CFR 888.3040 - Product Code HWC and MBI |

#### Predicate Devices:

- Parcus V-LoX PEEK CF Suture Anchor (K091094) .
- . Smith & Nephew BioRaptor 2.9 (K031685, K053344)

#### Device Description:

The Parcus PEEK CF Push-In Suture Anchors are tapered fasteners with barbs for use in attachment of soft tissue to bone. The devices are made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). The Push-In Suture Anchors are provided sterile in 3.0mm and 4.5mm diameters.

### Intended Use:

The Parcus PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

- Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
- Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, lliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

839 S NEENAH AVE., STURGEON BAY, WI 54235 >> 1-877-746-2972 >> www.parcusmedical.com

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Image /page/1/Picture/0 description: The image shows the logo for PARCUS Medical, LLC. Above the logo is the text K102162. The logo is black and white and features the company name in a bold, sans-serif font. The words "Medical, LLC" are smaller and to the right of the main logo.

SURGICAL INNOVATION >> VALUE DRIVEN

- Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.

- Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip Acetabular Labral Repair (3.0mm only)

#### Substantial Equivalence Summary:

The Parcus PEEK CF Push-In Suture Anchors are similar to the Parcus V-LoX PEEK CF Suture Anchors in that they are made of the same material, manufactured in a similar manner, and have similar indications. While the method of fixation differs, push-in barbs versus threads, it does not raise any new concerns regarding safety and efficacy.

The Parcus PEEK CF Push-In Suture Anchors are similar in design to the Smith & Nephew BioRaptor 2.9. Both anchors are barbed and pushed in rather than threaded. Although the BioRaptor is listed as 2.9mm, this is the minor diameter and the actual outer diameter is 3.5mm while the Push-In Suture Anchors come in 3.0mm and 4.5mm outer diameters. Though the material differs, PEEK CF versus a bioabsorbable polymer, it does not raise any new concerns regarding safety and efficacy.

Therefore the Parcus PEEK CF Push-In Suture Anchors are substantially equivalent to the predicate devices listed above. Any differences between the Push-In Suture Anchors and the predicate devices are considered minor and do not raise any safety and efficacy concerns.

#### Summary Performance Data:

The Parcus PEEK CF Push-In Suture Anchors were placed in prepared holes and the pull out strength was measured. Test results were compared to the results for the Parcus V-LoX PEEK CF Suture Anchors as well as the Smith & Nephew BioRaptor 2.9 and demonstrated substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Parcus Medical, LLC % Mr. Barton Bracy 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54234

NOV 1 0 2010

Re: K102162

Trade/Device Name: Parcus PEEK CF Push-In Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: October 20, 2010 Received: October 20, 2010

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. 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. 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 vours.

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): K102162

Device Name: _Parcus PEEK CF Push-In Suture Anchors

NOV 1 0 2010

## Indications for Use:

The Parcus PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

| Shoulder | Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Knee | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. |
| Foot/Ankle | Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. |
| Elbow | Tennis Elbow Repair, Biceps Tendon Reattachment. |
| Hand/Wrist | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. |
| Hip | Acetabular Labral Repair (3.0mm only) |

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oruta for mxm
(Division Sign Off)

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

510(k) Number K102162

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