MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE

K080352 · Depuy Mitek, A Johnson & Johnson Company · HWC · Mar 12, 2008 · Orthopedic

Device Facts

• Record ID: K080352
• Device Name: MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: HWC · Orthopedic
• Decision Date: Mar 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Microfix QA+: The Microfix QuickAnchor Plus is indicated for fixationof soft tissue to bone, using suture for the indications listed below. Hand: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP (distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Soft tissue attached to the parietal. Temporal ridge, frontal, mandible, maxilla, zygoma, and periobital bones of the skull. Micro QA+: The Micro QuickAnchor Plus(Micro QA+) is indicated for fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone. This product is intended for the indications listed below: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Lateral canthoplasty

Device Story

Preloaded, disposable suture anchor/inserter assembly; used for soft tissue-to-bone fixation in hand and skull procedures. Anchor design identical to predicate devices; utilizes #3-0 or #4-0 Orthocord suture. Operated by surgeons in clinical settings. Device provides mechanical fixation of soft tissue to bone; facilitates repair/reconstruction of ligaments and tendons. Benefits include secure tissue attachment during orthopedic and reconstructive procedures.

Clinical Evidence

Bench testing only. No clinical data presented. Testing demonstrated that the Micro QA+ and Microfix QA+ anchors with #3-0 and #4-0 Orthocord met all predetermined acceptance criteria.

Technological Characteristics

Metallic bone fixation fastener; preloaded disposable anchor/inserter assembly. Dimensions identical to predicate devices. Suture material: #3-0 or #4-0 Orthocord (braided composite).

Indications for Use

Indicated for fixation of soft tissue to bone in hand (collateral ligaments, flexor/extensor tendons at PIP, DIP, MCP joints) and skull (parietal, temporal ridge, frontal, mandible, maxilla, zygoma, periobital bones, or lateral canthoplasty).

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

• Micro QA+ Anchor (K032078, K982420, K962793, K962511)
• Microfix QA+ Anchor (K024115)

Submission Summary (Full Text)

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K08035-2 page-f2

# 510(k) SUMMARY

MAR 1 2 2008

### Micro QA+ with #3-0, #4-0 Orthocord Anchor / Microfix QA+ with #3-0, #4-0 Orthocord Anchor

| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo<br>Senior Regulatory Affairs Specialist<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br>Telephone:<br>508-828-3359<br>Facsimile:<br>508-977-6955<br>e-mail:<br>[e-mail] |
| Name of Medical Device | Classification Name: screw, fixation, bone<br>Common/Usual Name: Appliance for reconstruction of soft tissue to bone<br>Proprietary Name: Micro QA+ Anchor / Microfix QA+ Anchor |
| Substantial Equivalence | Micro QA+ Anchor with Orthocrod is substantially equivalent to:<br>Micro QA+ Anchor, K032078, K982420, K962793 and K962511,<br>manufactured by DePuy Mitek.<br>Microfix QA+ Anchor with Orthocord is substantially equivalent to:<br>Microfix QA+ Anchor, K024115, 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<br>* Single/Multiple component metallic bone fixation appliances and<br>accessories<br>* Smooth or threaded metallic bone fixation fattener<br>Micro QA+ : Single / multiple component metallic bone fixation |
| Device Description | Micro QA + with #3-0 Orthocord or #4-0 Orthcord / Microfix QA+ with<br>#3-0 Orthocord or #4-0 Orthcord are a preloaded, disposable suture<br>anchors/ inserters assembly for soft tissue repair to bone in the hand and<br>skull.<br><br>The anchor is dimensionally identical anchor to that of the Micro QA+<br>Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord / Microfix QA+<br>Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord |
| Indications for Use | Microfix QA+: The Microfix QuickAnchor Plus is indicated for<br>fixationof soft tissue to bone, using suture for the indications listed below.<br><br>Hand: Hand: Repair / reconstruction of collateral ligaments, flexor<br>and extensor tendon at the PIP (proximal interphalaangeal), DIP<br>(distal interphalaaangeal), and MCP (metacarpal interphalangeal)<br>joints for all digits.<br><br>Skull: Soft tissue attached to the parietal. Temporal ridge, frontal,<br>mandible, maxilla, zygoma, and periobital bones of the skull.<br><br>Micro QA+: The Micro QuickAnchor Plus(Micro QA+) is indicated for<br>fixation of non-absorbable braided polyester or partially absorbable<br>braided composite surgical suture to bone. This product is intended for the<br>indications listed below:<br><br>Hand: Repair / reconstruction of collateral ligaments, flexor and<br>extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal<br>interphalaaangeal), and MCP (metacarpal interphalangeal) joints for<br>all digits.<br><br>Skull: Lateral canthoplasty |
| Safety and Performance | The determination of substantial equivalence for this device was based on<br>a detailed device description, and conformance to consensus and voluntary<br>standards. Bench testing was performed demonstrating that the Micro<br>QA+ Anchor with #3-0 and #4-0 Orthocord / Microfix QA+ Anchor with<br>#3-0 and #4-0 Orthocord met predetermined acceptance criteria.<br><br>Based on the indications for use, technological characteristics, and<br>comparison to predicate devices, the Micro QA+Anchor and Microfix<br>QA+ Anchor has been shown to be substantially equivalent to predicate<br>devices under the Federal Food, Drug and Cosmetic Act |

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Microfix QA+: Smooth or threaded metallic bone fixation fattener under 21CRF 888.3040. Product Code: HWC

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Mitek % A Johnson & Johnson Company Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767

MAR 1 2 2008

K080352 Trade/Device Name: Micro QuickAnchor Plus and Microfix QuickAnchor Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MAI Dated: February 8, 2008 Received: February 11, 2008

Dear Ms. Christo:

Re:

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 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 - Ms. Kristine Christo

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark W. Milliman

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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#### INDICATIONS FOR USE

510(k) Number (if known): _Kofo3 52

## Device Name(s): Micro QuickAnchor Plus (Micro QA+ Anchor)

Indications for Use:

The Micro QuickAnchor Plus is indicated for fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone. This product is intended for the indications listed below:

Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits.

Skull: Lateral canthoplasty

## Device Name(s): Microfix QuickAnchor Plus (Microfix QA+ Anchor)

Indications for Use:

The Microfix QuickAnchor Plus is indicated for fixationof soft tissue to bone, using suture for the in dications listed below.

Hand: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits.

Skull: Soft tissue attached to the parietal. Temporal ridge, frontal, mandible, maxilla, zygoma, and periobital bones of the skull,

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use No (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, Page 1 of ____________________________________________________________________________________________________________________________________________________________________ and Neurological Devices

510(k) Number K080352