EXTREMITY MEDICAL SUTURE ANCHOR

K083151 · Extremity Medical, LLC · MBI · Jan 22, 2009 · Orthopedic

Device Facts

• Record ID: K083151
• Device Name: EXTREMITY MEDICAL SUTURE ANCHOR
• Applicant: Extremity Medical, LLC
• Product Code: MBI · Orthopedic
• Decision Date: Jan 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Device Story

Metallic bone fixation fastener; used for anchoring sutures to bone during orthopedic soft tissue repair procedures. Device implanted by surgeons in clinical settings (OR). Provides mechanical fixation of soft tissue to bone to facilitate healing. Benefits patient by restoring structural integrity to damaged ligaments or tendons in extremities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; smooth or threaded design; 21 CFR 888.3040 classification.

Indications for Use

Indicated for fixation of suture and/or soft tissue to bone in shoulder, foot/ankle, knee, hand/wrist, and elbow for patients requiring ligament, tendon, or capsular repair/reconstruction.

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

• Orthopaedic Biosystems Ltd, Inc (Smith & Nephew) TwinFix Ti 2.8 Suture Anchor (K972326)
• Smith & Nephew TwinFix PK FP Suture Anchor (K073509)

Submission Summary (Full Text)

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

## JAN 2 2 2009

## EXTREMITY MEDICAL Implant System

| Submitter | EXTREMITY MEDICAL LLC<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jamy Gannoe<br>President<br>Phone [phone]<br>Email [e-mail] |
| Date Prepared | December 18, 2008 |
| Trade Name | EXTREMITY MEDICAL Suture Anchor |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888 3040 |
| Product Code | MBI |
| Predicate Devices | 1 Orthopaedic Biosystems Ltd, Inc (Smith & Nephew)<br>TwinFix Tı 2 8 Suture Anchor K972326<br>2 Smith & Nephew TwinFix PK FP Suture Anchor<br>K073509 |
| Device Description | The EXTREMITY MEDICAL Suture Anchor |
| Indications for use | The Extremity Medical Suture Anchor is intended for the<br>fixation of suture and/or soft tissue to bone in the shoulder,<br>foot/ankle, knee, hand/wrist, elbow in the following procedures<br><br>Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion<br>Repair, Biceps Tenodesis, Acromio-Clavicular Separation<br>Repair, Deltoid Repair, Capsular Shift of Capsulolabral<br>Reconstruction<br><br>Foot/Ankle Lateral Stabilization, Medial Stabilization, Achilles<br>Tendon Repair, Hallux Valgus Reconstruction, Mid-foot |
| | |
| | reconstruction, Metatarsal Ligament Repair/Tendon Repair,<br>Bunionectomy |
| | <i>Knee</i> Medial Collateral Ligament Repair, Lateral Collateral<br>Ligament Repair, Patellar Tendon Repair, Posterior Oblique<br>Ligament Repair, Iliotibial Band Tenodesis |
| | <i>Hand/Wrist</i> Scapholunate Ligament Reconstruction, Ulnar or<br>Radial Collateral Ligament Reconstruction |
| | <i>Elbow</i> Biceps Tendon Reattachment, Tennis Elbow Repair,<br>Ulnar or Radial Collateral Ligament Reconstruction |
| Statement of<br>Technological<br>Comparison | The EXTREMITY MEDICAL Suture Anchor and its predicate<br>devices have the same indications for use have a similar design<br>and are made of the similar materials |
| Conclusion | The EXTREMITY MEDICAL Suture Anchor is substantially<br>equivalent to its predicate devices This conclusion is based<br>upon the fact that this device is substantially equivalent in terms<br>of indications for use, materials, design and principles of<br>operation |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Extremity Medical, LLC % Mr Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

JAN 2 2 2009

Re K083151

Trade/Device Name EXTREMITY MEDICAL Suture Anchor Regulation Number 21 CFR 888 3040 Regulation Name Smooth or threaded metallic bone fixation fastener Regulatory Class II Product Code MBI Dated October 22, 2008 Received October 24, 2008

Dear Mr Gannoe

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 adultcration

It 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 In tound 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 - Mr Jamy Gannoe

This letter will allow you to begin marketing your device as described in your Section 510(k) This lefter will allow you to begin makemily of substantial equivalence of your device to a legally
promatics notification The FDA finding of substance and thus, permits vo prematication - The PDA miding of Substantial squar device and thus, permits your device 10 proceed to the market

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please at if you desire specific advice for your device on our car as a this (CDRH's) Office of Complance at
contact the Center for Devices and Radiological Health is (CDRH) adapo by r Colliact the Content for Doviets and the regulation entitled, "Misbranding by reference to [phone] Also, prease note the regulation regulations regarding postmarket surveillance, premarket nothcation (21CPK Pat 067 97) please contact CDRF's Office of Burvemance and the reportung of device adverse events.
Surveillance at 240-276-3474 For questions regarding the reportung of developes at 24 (Medical Device Reporting (MDR)), please contact the Division of Survelliance Systems at 240-(Medical Device Reporting (MDX)); production on your responsibilities and the Act from
276-3464 You may obtain other general information on your responsibilities and the Ac 270-5404 - You may obtain other general michiner and Consumer Assistance at its toll-free the DIVATOR OF Small Mar [phone] or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sıncerely yours,

Mark N Mulkerson

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 Suture Anchor EXTRE

510(k) Number (if known) Device Name Indications for Use•

The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures

Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament

| Reconstruction |
|----------------|
|----------------|

| Prescription Use _X_ AND/OR Over-the-counter |
|----------------------------------------------|
|----------------------------------------------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division of General Restorative.

and Neurological Devices

| 21 510(k) Number | K083157 |
|------------------|---------|
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