SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)

K052631 · Depuy Mitek, A Johnson & Johnson Company · JDR · Oct 21, 2005 · Orthopedic

Device Facts

• Record ID: K052631
• Device Name: SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: JDR · Orthopedic
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below. Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair. Ankle: Achilles tendon repair/reconstruction. 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

Preloaded, metallic disposable suture anchor/inserter assembly; facilitates soft tissue-to-bone repair. Used by surgeons in clinical settings (OR). Device consists of metal anchor identical to predicate; compatible with various suture types (Ethibond, Panacryl, Orthocord). Surgeon deploys anchor into bone to secure suture, enabling tissue reattachment. Benefits include standardized, reliable fixation for orthopedic repairs.

Clinical Evidence

Bench testing only. Testing demonstrated that ORTHOCORD suture conforms to USP monograph for absorbable sutures and that suture compatibility and deployment meet predetermined acceptance criteria.

Technological Characteristics

Metallic bone fixation anchor; preloaded disposable inserter assembly. Compatible with USP #2-#5 sutures. Materials include metal anchor; sutures include Ethibond, Panacryl, or Orthocord. No software or electronic components.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder (rotator cuff, capsular, biceps, deltoid repairs), ankle (Achilles repair/reconstruction), and knee (extra capsular repairs, ligament/capsule reattachment, ITB tenodesis, patellar ligament/tendon avulsions) procedures using USP size #2 through #5 sutures.

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

• Super Quickanchor Plus (K041116)

Reference Devices

• Ethibond Suture (NDA 17-804 and 17-809)
• Panacryl Suture (K964345)
• Orthocord Suture (K040004)
• Orthocord Suture (K043298)

Submission Summary (Full Text)

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## OCT 2 1 2005

## 510(k) SUMMARY

## Super Quickanchor Plus

| Submitter's Name and Address: | DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062 |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Denise Luciano<br>Senior Regulatory Affairs Specialist<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 | Classification Name: Screw, Fixation, Bone Staple<br>Common/Usual Name: Appliance for reconstruction of soft tissue to bone<br>Proprietary Name: Super Quickanchor Plus |
| Substantial Equivalence | Super Quickanchor Plus (with ORTHOCORD) is substantially<br>equivalent to:<br>Super Quickanchor Plus, K041116, manufactured by DePuy Mitek. |
| Device Classification | Bone anchors/screws are classified by the FDA as Class II Medical<br>Devices under the generic category of Single/Multiple component<br>metallic bone fixation appliances and accessories.<br><br>Super Quickanchor Plus carry FDA product code JDR, and is classified<br>as a fixation screw/bone staple under 21 CFR 888.3030. |
| Device Description | Super Quickanchor Plus (with ORTHOCORD) is a preloaded, metallic<br>disposable suture anchor/ inserter assembly designed to allow soft<br>tissue repair to bone. The metal anchor is an identical anchor as that of<br>the Super Quickanchor Plus in design, configuration and dimensions.<br>The anchor system may be sold with Ethibond Suture (NDA 17-804 |
| 510(k) Premarket Notification: Special<br>Super Quickanchor Plus | Confidential |

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| | and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298). |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below. |
| | Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair. |
| | Ankle: Achilles tendon repair/reconstruction. |
| | 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. |
| Safety and Performance | The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria. |
| | Based on the indications for use, technological characteristics, and comparison to predicate devices, the Super Quickanchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |

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OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Denise Luciano Senior Regulatory Affairs Specialist Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K052631

Trade/Device Name: Super 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: September 22, 2005 Received: September 26, 2005

Dear Ms. Luciano:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed four be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use based in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered province with the provisions of the provisions of the Federal Food, Drug, do nots may been require approval of a premarket approval 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 rr your de rice 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 r hat 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 or any 1 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 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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Page2-Denise Luciano

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to orgin mailing of substantial equivalence of your device to a legally prematics notincation: The PDF interessification 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 If you desire specific arrive 10. Jour 2019) 276-0120. 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 other general mionnal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkerson

Acting 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

510(k) Number (if known): K082631

Device Names: Super Quickanchor Plus

Indications for Use:

The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.

Ankle: Achilles tendon repair/reconstruction.

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 of

510(k) Number: K052431

510(k) Premarket Notification: Special Super Quickanchor Plus

Confidential