MICROSUTURE ANCHORS

K112237 · Arthrex, Inc. · HWC · Sep 2, 2011 · Orthopedic

Device Facts

• Record ID: K112237
• Device Name: MICROSUTURE ANCHORS
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 2, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex MicroSuture Anchors is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Device Story

MicroSuture Anchors are bone fixation fasteners; line extension of existing anchors. Comprised of titanium or PLA/βTCP; provided preloaded on driver with suture. Diameter 2.2-2.7mm; length 4-7mm. Used by orthopedic surgeons in clinical/OR settings for soft tissue-to-bone fixation. Device inserted into bone to anchor sutures for tendon/ligament repair. Mechanical pull-out strength provides secure fixation, facilitating tissue healing. Benefits include minimally invasive stabilization of musculoskeletal structures.

Clinical Evidence

Bench testing only. Mechanical pull-out strength testing performed to compare subject device against predicate devices. No clinical data provided.

Technological Characteristics

Materials: Titanium or PLA/βTCP. Dimensions: 2.2-2.7mm diameter, 4-7mm length. Form factor: Preloaded on driver with suture. Principle: Mechanical bone fixation fastener.

Indications for Use

Indicated for suture or tissue fixation in foot/ankle, knee, hand/wrist, elbow, and shoulder for patients requiring ligament/tendon repair or reconstruction, including rotator cuff, biceps, collateral ligaments, and joint arthroplasty.

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

• Arthrex Corkscrew Suture Anchor (K061863)
• Arthrex Mini PushLock (K063479)
• Arthrex Micro BioComposite Suture Tak (K091844)

Submission Summary (Full Text)

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# SEP - 2 2011

Arthrex SPECIAL 510(K): Arthrex MicroSuture Anchors

## 2 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared | August 2, 2011 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor<br>/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Courtney Smith<br>Manager, Regulatory Affairs<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1720<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | MicroSuture Anchors |
| Common Name | Screw, Fixation, Bone |
| Product Code -<br>Classification Name | HWC – Screw, fixation, bone<br>MAI – Fastener, fixation, biodegradable, soft tissue<br>MBI – Fastener, fixation, nondegradable, soft tissue<br>21 CFR 888.3030: Single/multiple component metallic bone<br>fixation appliances and accessories.<br>21 CFR 888.3040: Smooth or threaded metallic bone fixation<br>fastener |
| Predicate Devices | K061863: Arthrex Corkscrew Suture Anchor<br>K063479: Arthrex Mini PushLock<br>K091844: Arthrex Micro BioComposite Suture Tak |
| Device Description and<br>Intended Use | The Arthrex MicroSuture Anchors consist of four anchors<br>which are line extensions to existing anchors. The new anchors<br>are comprised of titanium or PLA/ βTCP and are provided<br>preloaded on a driver with suture. The anchors range from 2.2-<br>2.7mm in diameter and 4-7mm in length.<br><br>The Arthrex MicroSuture Anchors are intended to be used for<br>suture or tissue fixation in the foot/ankle, knee, hand/wrist,<br>elbow, and shoulder. Specific indications are listed below:<br>Elbow: Biceps Tendon Reattachment, Ulnar or Radial<br>Collateral Ligament Reconstruction<br>Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion<br>Repair, Biceps Tenodesis, Acromio-Clavicular<br>Separation Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction |
| | Repair/Reconstruction of collateral ligaments, Repair<br>of Flexor and Extensor Tendons at the PIP, DIP and<br>MCP joints for all digits, digital tendon transfers,<br>Carpal Ligament Reconstruction and Carpometacarpal<br>joint arthroplasty (basal thumb joint arthroplasty) |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles<br>Tendon Repair, Metatarsal Ligament Repair, Hallux<br>Valgus reconstruction, digital tendon transfers, Mid-<br>foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral<br>Ligament Repair, Patellar Tendon Repair, Posterior<br>Oblique Ligament Repair, Iliotibial Band Tenodesis |
| Substantial Equivalence<br>Summary | The Arthrex MicroSuture Anchors are substantially equivalent<br>to the Arthrex Corkscrew, Arthrex Mini PushLock and Micro<br>BioComposite Suture Tak predicates, in which the basic<br>features, and intended uses are the same. Any differences<br>between the MicroSuture Anchors and the predicates are<br>considered minor and do not raise questions concerning safety<br>and effectiveness. |
| | The mechanical testing demonstrates that the pull-out strength of<br>the proposed devices meets or exceeds the pull-out strength of<br>the predicate devices. Based on the indication for use,<br>technological characteristics, and the comparison to the predicate<br>device, Arthrex, Inc. has determined that the Arthrex<br>MicroSuture Anchors are substantially equivalent to currently |

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Arthrex SPECIAL 510(k): Arthrex MicroSuture Anchors

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KII2237

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wings or feathers.

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

Arthrex, Inc. % Ms. Courtney Smith 1370 Creekside Blvd. Naples. Florida 34108-1945

SEP - 2 2011

Re: K112237

Trade/Device Name: Arthrex MicroSuture Anchors-Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI, MBI Dated: August 2, 2011 Received: August 4, 2011

Dear Ms. Smith:

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

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Page 2 – Ms. Courtney Smith

device-related adverse events) (21 CFR 803): 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. 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/ReportalProblem/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 yours,

Erine D. Keith

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 Form 1

## Indications for Use

510(k) Number:

K112237

Device Name:

Arthrex MicroSuture Anchors

Indications For Use:

### Indications for Use:

The Arthrex MicroSuture Anchors is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Repair/Reconstruction of<br>collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP,<br>DIP and MCP joints for all digits, digital tendon transfers, Carpal<br>Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal<br>thumb joint arthroplasty) |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,<br>Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital<br>tendon transfers, Mid-foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,<br>Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial |

Prescription Use X _ AND/OR Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

Band Tenodesis

(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)

PAGE 1 of 1

for M. Melleveron

(Division Sigh Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112237