GII QUICKANCHOR PLUS

K041115 · Depuy Mitek, A Johnson & Johnson Company · JDR · May 28, 2004 · Orthopedic

Device Facts

• Record ID: K041115
• Device Name: GII QUICKANCHOR PLUS
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: JDR · Orthopedic
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux valgus reconstruction. Wrist: Scapholunate ligament. Hand: Ulnar or lateral collateral ligament reconstruction. Elbow: Tennis elbow repair, biceps tendon reattachment. Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Device Story

Metallic bone anchor system; used for reattaching soft tissue to bone; consists of 6Al-4V ELI titanium base and NiTi titanium alloy arcs; includes inserter shaft and suture (Ethibond or Panacryl). Designed for orthopedic surgical procedures; operated by surgeons in clinical/OR settings. Features single-handed operation and extended inserter shaft length for improved ergonomics and visualization. Provides secure suture fixation to bone; facilitates tissue healing; reduces surgical complexity through enhanced handling characteristics.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design similarity to predicate and biocompatibility testing demonstrating the device is non-toxic, non-irritating, and non-cytotoxic.

Technological Characteristics

Metallic bone anchor; materials: 6Al-4V ELI Titanium base and NiTi (Nickel-Titanium) alloy arcs. Form factor: anchor with inserter shaft. Connectivity: N/A. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, ankle, foot, wrist, hand, elbow, and knee procedures, including ligament, tendon, and capsule repairs/reconstructions in adult patients requiring suture fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Mitek GII Anchor (K915889)

Submission Summary (Full Text)

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# 510(k) Summary – GII QuickAnchor Plus

| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062 |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Allyson Barford<br>Regulatory Affairs Associate<br>DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>Telephone: [phone]<br>Facsimile: 781-278-9578<br>e-mail: [e-mail] |
| Name of Medical Device | Device Regulation:<br>Staple, Fixation, Bone<br>(21 CFR 888.3030)<br>Product code: MBI<br>Common/Usual Name:<br>Staple, Fixation, Bone<br>Proprietary Name:<br>GII Quick Anchor Plus |
| Device Classification | Staple, Fixation, Bone devices have been classified as Class II, MBI<br>according to 21 CFR 888.3030. No performance standards have been<br>established under Section 514 of the Food, Drug and Cosmetic Act for<br>Staple, Fixation, Bone devices. |
| Indications for Use | The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of<br>USP size #2 suture to bone for the indications listed below.<br>Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular<br>separation, rotator cuff repair, capsule shift/capsulo-labral<br>reconstruction, biceps tenodesis, deltoid repair.<br>Ankle: Lateral instability, medial instability, achilles tendon<br>repair/reconstruction, midfoot reconstruction.<br>Foot: Hallux valgus reconstruction. |
| Special 510(k) Premarket Notification: GII QuickAnchor Plus<br>DePuy Mitek | CONFIDENTIAL |

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Wrist: Scapholunate ligament. Hand: Ulnar or lateral collateral ligament reconstruction. Filbow: Tennis elbow repair, biceps tendon reattachment. Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions. The GII QuickAnchor Plus is intended as an upgrade of the current GII Device Description Anchor. While retaining the current GII Anchor design, the new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The GII Anchor is a metallic (6A1-4V ELI Titanium base and NiTi Titanium Alloy arcs) and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek GII Anchor (K915889). Based on the type of changes being made and the fact that the GII Substantial Equivalence QuickAnchor Plus represents the same fundamental scientific technology as the existing GII Anchor; Mitek believes the GII QuickAnchor Plus is substantially equivalent to Mitek's existing GII Anchor (K915889). Biocompatibility studies have demonstrated the GII QuickAnchor Plus Safety to be non-toxic, non-irritating, and non-cytotoxic.

#### CONFIDENTIAL

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K041115 Trade/Device Name: GII QuickAnchor Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: April 6, 2004 Received: April 29, 2004

Dear Ms Barford:

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 10 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, I'DA 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 rcquirements 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.

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## Page 2 - Allyson Barford

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in you attire Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Mallekerson

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

041115 510(k) Number (if known):

Device Names

GII QuickAnchor Plus

Indications for Use:

The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.

Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.

Foot: Hallux valgus reconstruction.

Wrist: Scapholunate ligament.

Hand: Ulnar or lateral collateral ligament reconstruction.

Elbow: Tennis elbow repair, biceps tendon reattachment.

Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

**(Division Sign-Off)**

Special 510(k) Premarket Notification: GII Quick DePuy Mitck

**510(k) Number** K041115