G-FORCE PEEK SUTURE ANCHOR SYSTEM

K100630 · Wrightmedicaltechnologyinc · MBI · Jun 11, 2010 · Orthopedic

Device Facts

• Record ID: K100630
• Device Name: G-FORCE PEEK SUTURE ANCHOR SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBI · Orthopedic
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The G-FORCE® Suture Anchor System is indicated for use: - In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; - In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis; - In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.

Device Story

G-FORCE® Suture Anchor System is a sterile, single-use, hand-held device for attaching soft tissue to bone. System includes PEEK-OPTIMA® anchors preloaded with Force Fiber™ (polyethylene-based) sutures and tapered needles. Used by surgeons in clinical settings to repair instability in shoulder, elbow, hand/wrist, knee, and foot/ankle. Surgeon inserts anchor into bone to secure soft tissue; provides mechanical fixation for tissue healing. Benefits include stable reattachment of ligaments/tendons to bone.

Clinical Evidence

Bench testing only. Torque and tensile strength characteristics were tested to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Anchors: PEEK-OPTIMA®; Sutures: Force Fiber™ (polyethylene-based); Needles: Tapered. Anchor diameters: 3.5 and 5.0mm. Sterilization: Ethylene oxide gas. Mechanical fixation device.

Indications for Use

Indicated for patients requiring soft tissue-to-bone repair in the shoulder, elbow, hand/wrist, knee, and foot/ankle due to instability, tears, or detachments of specific ligaments and tendons.

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

• ANCHORLOK® Soft Tissue Anchor System (K971282)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a design consisting of three horizontal lines that are thicker in the middle and taper off towards the ends. The lines are slightly curved, giving the impression of a stylized wing or swoosh.

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JUN 1 1 2010

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the G-FORCE® Suture Anchor System.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|------------------------------------------------------------------------------------|
| Date: | March 3, 2010 |
| Contact Person: | Kellen Hills |
| Title: | Sr. Regulatory Affairs Specialist |
| Address: | 5677 Airline Road, Arlington TN 38002 |
| Phone: | 800.238.7117 |
| Proprietary Name: | G-FORCE® Suture Anchor System |
| Common Name: | Soft Tissue Anchor |
| Classification Name and Reference: | 21 CFR 888.3040 - Smooth or threaded metallic bone<br>fixation fastener - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/MBI/HWC |
| Predicate Device: | ANCHORLOK® Soft Tissue Anchor System<br>(K971282) |

### DEVICE INFORMATION

#### A. DEVICE DESCRIPTION

The G-FORCE® Suture Anchor is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The G-FORCE® Suture Anchor comes preloaded with non-absorbable polyethylene-based sutures, needles and PEEK-OPTIMA® anchors. The anchors are available in a variety of sizes with correspondingly sized suture.

## B. INDICATIONS FOR USE

The G-FORCE® Suture Anchor System is indicated for use:

- In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap . lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ● ulnar or radial collateral ligament tear/separation;

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K100630 p. 2 of 2

- In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- In the repair of knee instability secondary to tear or separation of the medial collateral . ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis; י
- In the repair of foot/ankle instability secondary to tear or separation of the Achilles . tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use of the G-FORCE® Suture Anchor System are limited in scope when compared to the predicate. The technological characteristics by which the intended use is achieved is the same for both the subject and predicate systems.

The safety and effectiveness of the G-FORCE® Suture Anchor System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k).

| | G-FORCE® Suture Anchor | ANCHORLOK® Soft Tissue Anchor System |
|-----------------------|---------------------------------------------------------------------|------------------------------------------|
| Device | Subject Device | Predicate (K971282) |
| Implants<br>Materials | Anchors: PEEK-OPTIMA®<br>Sutures: Force Fiber™ (polyethylene based) | Anchors: Ti-6Al-4V<br>Sutures: polyester |
| Anchor<br>Diameters | 3.5 and 5.0mm | 1.9, 2.5, 3.5, 5.0 and 7.5mm |
| Suture Thickness | #2 | 2-0, 1-0 and #2 |
| # of sutures | 2 per anchor | 1 per anchor |
| Needles | Tapered | Reverse cutting |
| Driver diameter | Consistent | Variable |
| Sterilization | Ethylene oxide gas | Gamma irradiation |

Comparison of the G-FORCE® Suture Anchor and the predicate

## D. PERFORMANCE DATA

Bench testing was used to demonstrate that the torque and tensile strength characteristics of the G-FORCE® Suture Anchor System are substantially equivalent to the predicate.

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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 stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. c/o Mr. Kellen Hills Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

#### JUN 1 1 2010

Re: K100630

Trade/Device Name: G-FORCE® Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: June 7, 2010 Received: June 9, 2010

Dear Mr. Hills:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to regars annent date of the Medical Device Amendments, or to commerce pror to trial 20, 1978, in 1978, in 1998, in 1998, in the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costicule Act (71cc) that to not request to the general controls provisions of the Act. The 1 ou may, incretore, market the act include requirements for annual registration, listing of gencial controls provisions of wactice, labeling, and prohibitions against misbranding and devices, good manufacturing praction, as thanguation related to contract liability additeration. Tease note: ODFET accomment 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 such additional controls. Existing major regulations affecting your device can may be subject to back address and egulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the South announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I Dri 3 ibsudies of our device complies with other requirements of the Act that i DA has made a determinations administered by other Federal agencies. You must or ally it catal statures and regulations and limited to: registration and listing (21

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#### Page 2 - Ms. Kellen Hills

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A ratt 077); identing (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/ReportaProblem/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 I ou may 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,

Darbar buem

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

510(k) Number (if known): Қ100630

Device Name: G-FORCE® Suture Anchor System

Indications For Use:

The G-FORCE® Suture Anchor System is indicated for use:

- In the repair of shoulder instability secondary to Bankart lesion, rotator . In the repair of shoulder instablity overnments on biceps tenodesis, cull tear, a sidp 16thom capsular shift or capsulolabral reconstruction,
- delloid teamseparation, or capoural condary to biceps tendon detachment, . in the repair of elbow instally of ateral ligament tear/separation;
- tellinis elbow, of alhar of facilar of facility secondary to tear or separation of the . In the repair of nand/whist instabliky obsertaily nor radial collateral ligament;
- ligament,
In the repair of knee instability secondary to tear or separation of the . In the repair on knee instablityal ligament, patellar tendon, or medial collaterar ligament, latered only to iliotibial band tenodesis;
- posterior oblique ligancent, or occondary to tear or separation of the . stabilization tendons/ligaments, medial lateral tendon. Achilles Achilies - tendon, - lateral - otabilizations/ligaments, or metatarsal tendons/ligaments.

Prescription Use XXX (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)

Sonata for Nixon

(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100636

Concurrence of CDRH, Office of Device Evaluation (ODE)