WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055

K083792 · Medshape Solutions · HWC · Mar 25, 2009 · Orthopedic

Device Facts

• Record ID: K083792
• Device Name: WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055
• Applicant: Medshape Solutions
• Product Code: HWC · Orthopedic
• Decision Date: Mar 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedShape Solutions, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis in the following procedures: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Shoulder: Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

Device Story

WedgeLoc™ Suture Anchor is a sterile, single-use, two-piece 'push-in' bone anchor; consists of crosslinked Methyl methacrylate (MMA) polymer body and PEEK-OPTIMA® eyelet. Pre-loaded with two non-absorbable USP No. 2 Opti-Fiber™ polyblend sutures. Device utilizes compression to secure eyelet and sutures into pre-drilled bone hole. Used by surgeons in orthopedic procedures (shoulder, foot/ankle, knee, hand/wrist, elbow, pelvis) to approximate soft tissue to bone. Output is mechanical fixation of suture to bone; facilitates healing by maintaining tissue position. Benefits include secure soft tissue attachment during surgical repair.

Clinical Evidence

Bench testing only. In-vitro functional performance testing conducted in cancellous and cortical bone analogues. Biocompatibility screening performed in compliance with ISO 10993:2003.

Technological Characteristics

Two-piece 'push-in' bone anchor. Materials: crosslinked Methyl methacrylate (MMA) polymer (Memori™ 7111) body; PEEK-OPTIMA® eyelet. Sutures: non-absorbable USP No. 2 polyblend (polyethylene terephthalate core, polyethylene cover). Sterile, single-use. Mechanical fixation principle.

Indications for Use

Indicated for fixation of suture to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis for soft tissue repair procedures including rotator cuff, Bankart, SLAP, biceps tenodesis, ligament reconstructions, and tendon repairs.

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 PushLock™ suture anchor (K051219)
• Arthrex FiberWIRE™ polyblend suture (K021434)

Reference Devices

• CP-Fiber™ USP No. 2 sutures (K041894)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for Medshape Solutions. The word "MEDSHAPE" is in large, bold, black letters. Underneath the word "MEDSHAPE" is a line, and below that is the word "SOLUTIONS" in smaller, black letters.

510(k) Page __________________________________________________________________________________________________________________________________________________________________ of ___________________________________________________________________________________________________________________________________________________________________________

## 510(k) Summary

K083792 510(k) Number:

March 18th, 2008 Date Prepared:

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

- Submitter: A. MedShape Solutions, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Jack Griffis Vice President, Research & Development [phone] x11 (direct) [phone] (fax) Jack [e-mail]
- ். Preparer: Max Sherman Sherman Consulting Services, Inc. 339 East Wildwood Drive Warsaw, Indiana 46580 [phone] (direct) [phone] (fax)
- Device Information: D. WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures Trade Name: Suture Anchor Common Name:
- Fastener, Fixation, Non-degradable, Soft Tissue E. Classification Name: HWC/MBI and GAT 21 CFR 888.3040
- . F. Predicate Device(s): Arthrex PushLock™ suture anchor, K051219 Arthrex FiberWIRE™ polyblend suture, K021434

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- G. Physical Description:
The proposed WedgeLoc™ Suture Anchor is a sterile, single use, two piece "push-in" bone anchor. The suture anchor is designed to use the principles of compression to force the eyelet, pre-loaded with non-absorbable suture, into a hole created in the bone. The suture anchor body is comprised of a crosslinked Methyl methacrylate (MMA) polymer (comprised of Memori™ 7111. refer to MAF #1533) and PEEK eyelet (comprised of PEEK-OPTIMA® by Invibio®, refer to MAF #1209).

Each suture anchor is preloaded with two non-absorbable USP No. 2 sutures. The polyblend surgical suture provided with the proposed WedgeLoc™ Suture Anchor is provided by CP Medical, and has previously been cleared for market under K041894. In addition, these sutures meet USP requirements as described in the USP monograph for non-absorbable surgical sutures. Opti-Fiber™ non-absorbable polyblend surgical sutures are made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover and are identical to the CP-Fiber™ USP No. 2 sutures described in K041894. In addition, the predicate Arthrex FiberWIRE™ polyblend suture was listed as the predicate for the CP-Fiber™ in the premarket notification K041894.

- H. Indications for Use:
The WedgeLoc™ Suture Anchor and Opti-Fiber™ sutures are indicated for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

- Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Shoulder: Tenodesis, Acromio-Clavicular Separation Repair. Biceps Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair. Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Knee: Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Collateral Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Ligament Reconstruction
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial collateral Ligament Reconstruction

Image /page/1/Picture/12 description: The image shows the logo for MEDSHAPE. The word "MEDSHAPE" is in large, bold, black letters. Underneath "MEDSHAPE" is the word "SOLUTIONS" in smaller, thinner, black letters.

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K083792(pg 3/3)

510(k) Page ______________ of_

l. Comparison of Technological Characteristics: The WedgeLoc™ Suture Anchor and Opti-Fiber™ sutures are substantially equivalent in design, function and intended use to the following predicate devices:

Arthrex PushLock™ suture anchor, K051219 Arthrex FiberWIRE™ polyblend suture, K021434

Both suture anchors are comprised of a two part assembly; main body and evelet. The evelets of both suture anchors are made from PEEK-OPTIMA® material. The main body of the proposed WedgeLoc™ Suture Anchor differs from the predicate device as it is comprised of a cross-linked Methyl methacrylate (MMA) (Memori™ 7111) instead of PEEK-OPTIMA® material. The Memori™ 7111 has successfully passed biocompatibility screening in compliance with ISO 10993:2003 Biological evaluation of medical devices (refer to MAF #1533). Both anchors are deployed using a "push in" or "tap in" process for securing their polyblend sutures into bone. Both suture anchors have the same indications for use.

Both predicate and proposed Opti-Fiber™ sutures are indicated for use in soft tissue approximation; both meet USP for non-absorbable sutures, may be silicone coated or uncoated, and may be dyed or undyed with an appropriate FDA listed color additive. The proposed Opti-Fiber™ suture has previously been cleared for market as per K041894.

Functional performance testing was conducted in-vitro. This testing was conducted in both cancellous and cortical bone analogues. Analysis of the results substantiates the statement that the proposed device performs as well as or better than the predicate device.

Jack Griffis Vice President, Research & Development

Image /page/2/Picture/9 description: The image shows the logo for MEDSHAPE SOLUTIONS. The word "MEDSHAPE" is in large, bold, black letters. Below it, the word "SOLUTIONS" is in smaller, thinner, black letters with a line above it.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 a stylized human figure with outstretched arms.

MAR 2 5 2009

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

MedShape Solutions % Mr. Jack Griffis Vice President, Research & Development 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318

Re: K083792

Trade/Device Name: WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic fixation fastener Regulatory Class: II Product Code: HWC, MBI, GAT Dated: March 18, 2009 Received: April 12, 2009

Dear Mr. Griffis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications felerenced above and nave acterificated predicate devices marketed in interstate 101 use stated in the encreate) to regary che enactment date of the Medical Device Amendments, or to commence provide to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosment Acr (Act) that to not required to the general controls provisions of the Act. The r ou may, merciole, market the device, boojes resuirements for annual registration, listing of general Controls provisions of the rist 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 II your device is classified (soc above) into Existing major regulations affecting your device can may be subject to such additional oblines - Lifeting and to 898. In addition, FDA may be found in the Gode acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that TDA has made a determination administered by other Federal agencies. You must or any Federal statutes and regulations daminities or registration and listing (21 comply with an the Act 3 requirements, n.v., good manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 820); and if applicable, the electronic a forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Jack Griffis

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 yours,

For Peter D. Rummell

Mark N. Melkerson ) 0 ( Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Page ___ of _

## Indications for Use

510(k) Number: K083792

Device Name: WedgeLoc™ Suture Anchor and Opti-Fiber™ Sutures

Indications for Use:

The MedShape Solutions, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis in the following procedures:

- Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Shoulder: Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| (k) Number | 14083792 |
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