WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,

K091202 · Medshape Solutions · HWC · Sep 16, 2009 · Orthopedic

Device Facts

• Record ID: K091202
• Device Name: WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,
• Applicant: Medshape Solutions
• Product Code: HWC · Orthopedic
• Decision Date: Sep 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedShape Solutions, Inc., WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Elbow: Ligament Reconstruction

Device Story

WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures; used for soft tissue-to-bone fixation in orthopedic procedures. Device functions as mechanical fastener; anchors suture into bone to facilitate tissue repair. Used by surgeons in clinical/OR settings. Provides secure attachment point for sutures; enables reattachment of tendons/ligaments to bone. Benefits patient by restoring structural integrity of damaged joints/tissues.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Suture anchor system for bone fixation. Materials include non-degradable synthetic components. Mechanical fixation principle. Class II device.

Indications for Use

Indicated for fixation of suture to bone in shoulder, foot/ankle, knee, hand/wrist, and elbow procedures, including rotator cuff, Bankart, SLAP, biceps, acromio-clavicular, deltoid, capsular, ligament, tendon, and hallux valgus repairs/reconstructions.

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

• WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K083792)
• Arthrex PushLock™ Suture Anchor (K051219)
• Arthrex FiberWIRE™ Polyblend Suture (K021434)

Submission Summary (Full Text)

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K091202 (pg 1/2)

Image /page/0/Picture/1 description: The image shows the logo for Medshape Solutions. The word "MEDSHAPE" is in large, bold, black letters on the top line. Underneath the first word is a horizontal line, and below that is the word "SOLUTIONS" in smaller, black letters.

SEP 16 2009

Special 510(k) Page 10 of 140

## Special 510(k) Summary

Special 510(k) Number:

April 23rd, 2009 Date Prepared:

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

- Submitter: A. MedShape Solutions, Inc. (MSS) 1575 Northside Drive. Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Jack Griffis Vice President, Research & Development [phone] x11 (direct) [phone] (fax) [e-mail]
- C. Device Information: WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures Trade Name: Common Name: Suture Anchor
- Fastener, Fixation, Non-degradable, Soft Tissue Classification Name: D. HWC/MBI 21 CFR 888.3040 Suture, Nonabsorbable, Synthetic, Polyethylene GAT 21 CFR 878.500
- E. Predicate Device(s): MSS, WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture, K083792 Arthrex PushLock™ Suture Anchor, K051219 Arthrex FiberWIRE™ Polvblend Suture, K021434
- F. Labeling and Intended Use:

NOTE: Draft labels and instructions for use can be found in Attachment D. However, no changes to the labeling or Instructions for Use have been made to the original submitted information per K083792.

The proposed WedgeLoc™ 180X Suture Anchor and Opti-Fiber™ Suture has the same intended uses as the previously cleared device (K083792). In particular, both devices are indicated for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

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1,091202 Lpg 212)

Special 510(k) Page L of 10

- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, 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 Ligament Ligament Reconstruction, Radial Collateral Reconstruction
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial collateral Ligament Reconstruction
- Substantial Equivalence Summary: G.

The proposed WedgeLoc™ 180X Suture Anchor is is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K08379) and the Arthrex PushLock™ Suture Anchor (K051219) in which the basic features and intended uses are the same. In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ Suture Anchors are equivalent. Any differences between the WedgeLoc™ 180X Suture Anchor and the predicate WedgeLoc™ or Arthrex PushLock™ Suture Anchors are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, MedShape Solutions, Inc. has determined that the new WedgeLoc™ 180X Suture Anchor is substantially equivalent to the currently marketed predicate device.

04/23/2009

Jack Griffes Vice President, Research & Development

Image /page/1/Picture/11 description: The image shows the logo for MEDSHAPE SOLUTIONS. The word "MEDSHAPE" is in large, bold, black letters, with a line underneath it. Below the line, the word "SOLUTIONS" is written in smaller, black letters.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

SEP 1 6 2009

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

MedShape Solutions % Jack Griffis · 1575 Northside Drive. Suite 440 Atlanta, Georgia 30318

#### Re: K091202

Trade/Device Name: WedgeLoc™ 180x Suture Anchor and Opti-Fiber™ Sutures Regulation Number: 21 CFR 888.3040

Regulation Name: Smooth or threaded metallic bone fixation fastener

Regulatory Class: Class II

Product Code: HWC, MBI, GAT

Dated: September 2, 2009

Received: September 4, 2009

### Dear Mr. Griffis:

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 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 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.

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Page 2 - Mr. Jack Griffis

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/CDRH0ffices/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Boubeau Buchus
for

Mark N. Melk 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: K091202

Device Name: WedgeLoc™ 180X Suture Anchor and Opti-Fiber™ Sutures

#### Indications for Use:

The MedShape Solutions, Inc., WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair

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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Elbow: Ligament Reconstruction

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onetu
(Division Sign-Off) for mxn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091202