MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD

K071257 · Depuy Mitek, A Johnson & Johnson Company · JDR · Jun 29, 2007 · Orthopedic

Device Facts

• Record ID: K071257
• Device Name: MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: JDR · Orthopedic
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder: Bankart Repair Wrist: Scapholunate ligament reconstruction. Hand: Thumb ulnar or radial collateral ligament. Foot: Hallux valgus reconstruction. Ankle: Midfoot reconstruction. The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Wrist: Scapholunate ligament reconstruction. Hand: Thumb ulnar or radial collateral ligament. Foot: Hallux valgus reconstruction. Ankle: Midfoot reconstruction.

Device Story

Preloaded disposable anchor/inserter assemblies designed for soft tissue-to-bone fixation. Device consists of metallic bone anchor and Orthocord suture. Used by surgeons in clinical/OR settings to secure soft tissue to bone during orthopedic reconstructive procedures. Operates via mechanical insertion of anchor into bone, providing fixation point for suture. Benefits patient by facilitating stable tissue reattachment, supporting healing during postoperative immobilization period.

Clinical Evidence

Bench testing only. Biocompatibility studies demonstrated the devices are non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

Technological Characteristics

Metallic bone fixation fastener and absorbable/non-absorbable suture (Orthocord). Preloaded disposable anchor/inserter assembly. Class II medical device. No software or electronic components.

Indications for Use

Indicated for soft tissue to bone fixation in patients requiring surgical repair of the shoulder (Bankart), wrist (scapholunate ligament), hand (thumb collateral ligament), foot (hallux valgus), or ankle (midfoot), provided adequate postoperative immobilization is maintained.

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

• Mini QuickAnchor Plus (K930892, K992487, K992623)
• MINILOK Quick Anchor Plus (K030995)
• Orthocord Suture Size 2 (K043298, K04004)

Submission Summary (Full Text)

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K071257 pg 1 of 2

JUN 2 9 2007

## SECTION 2 - 510(k) SUMMARY revised 6/13/07

## MINILOK QuickAnchor Plus with Orthocord Mini QuickAnchor Plus with Orthocord

Address:

Contact Person

Submitter's Name and DePuy Mitek a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Kristine Christo Senior Regulatory Affairs Associate DePuv Mitek a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Telephone: [phone] 977-6911 Facsimile: e-mail: [e-mail] Name of Medical Device Fastener, Fixation, Biodegradable, Soft Tissue Classification Name: Common/Usual Name: Bone Anchor Proprietary Name: MINILOK QuickAnchor Plus Classification Name: Smooth or threaded metallic bone fixation fastener Common/Usual Name: Bone Anchor Proprietary Name: Mini QuickAnchor Plus Classification Name: Absorbable PDS suture, nonabsorbable polyethylene suture Common/Usual Name: Suture Proprietary Name: Orthocord Suture Substantial Equivalence MINI QuickAnchor Plus w/ Orthocord, MINILOK QuickAnchor w/

Orthocord, and Orthocord Suture size 2-0, are substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623): MINILOK Quick Anchor Plus (K030995); and Orthocord Suture Size 2 (K043298, K04004) manufactured by DePuy Mitek. Bone anchors/screws are classified by FDA as a Class II Medical Devices under Device Classification the generic categories of Single/Multiple Component Metallic Bone Fixation Appliances, Orthopedic

Devices Panel (reference 21 CFR §888.3030). Product code MAI. ,

Smooth or threaded metallic fastener (reference 21 CFR §888.3040)

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page 2 of 2

:

| Product code: | HWC |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sutures are classified by the FDA as Class II Medical Devices under the category of absorbable polydioxanone surgical suture(reference 21 CFR §878.4840) Product code:NEW, GAT |

| Device Description | The MiniQuick Anchor Plus w/ Orthocord, and MINILOK QuickAnchor w/ Orthocord, are preloaded disposable anchor/inserter assemblies designed to facilitate the delivery and installation of the anchor into bone. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proposed Indications for Use | The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:<br>Shoulder: Bankart Repair<br>Wrist: Scapholunate ligament reconstruction.<br>Hand: Thumb ulnar or radial collateral ligament.<br>Foot: Hallux valgus reconstruction.<br>Ankle: Midfoot reconstruction.<br><br>The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:<br>Wrist: Scapholunate ligament reconstruction.<br>Hand: Thumb ulnar or radial collateral ligament.<br>Foot: Hallux valgus reconstruction.<br>Ankle: Midfoot reconstruction. |
| Safety | Biocompatibility studies have demonstrated the MiniQuick Anchor Plus w/ Orthocord, MINILOK QuickAnchor w/ Orthocord, to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Mitek a Johnson & Johnson company % Ms. Kristine Christo Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

JUN 2 9 2007

Re: K071257

Trade/Device Name: MINILOK QuickAnchor Plus with Orthocord Mini QuickAnchor Plus with Orthocord Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HWC, MAI Dated: May 3, 2007 Received: May 4, 2007

Dear Ms. Christo:

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 - Ms. Kristine Christo

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 toll-free number [phone] or 240-276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkerson
Director

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

Enclosure

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page 1 of 2

# INDICATIONS FOR USE revised 6/13/07

510(k) Number (if known): K071257

Device Name(s): MINILOK QuickAnchor Plus w/ Orthocord

Indications for Use:

The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

Wrist: Scapholunate ligament reconstruction. Hand: Thumb ulnar or radial collateral ligament. Foot: Hallux valgus reconstruction. Ankle: Midfoot reconstruction.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

or

Over-the-Counter Use No

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dd

Division Sign-Off Division of General, Restorative, and Neurological Devices

51062) Number

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# INDICATIONS FOR USE revised 6/13/07

510(k) Number (if known): K071257

Device Name(s): MINI QuickAnchor Plus w/ Orthocord

Indications for Use:

The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

Shoulder: Bankart Repair Wrist: Scapholunate ligament reconstruction. Hand: Thumb ulnar or radial collateral ligament. Foot: Hallux valgus reconstruction. Ankle: Midfoot reconstruction.

Prescription Use ____x______x

or or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) . . . : المستقل المستقل المستوى الموضوع الموضوع الموضوع الموضوع الموضوع المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المست

Concurrence of CDRH, Office of Device Evaluation (ODE)