EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)

K111471 · Medshape Solutions, Inc. · MBI · Jun 10, 2011 · Orthopedic

Device Facts

• Record ID: K111471
• Device Name: EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
• Applicant: Medshape Solutions, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 10, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedShape Solutions, Inc., ExoShape™-XL Interference Fixation Device is intended for fixation of soft tissue to bone in the following procedures: Shoulder: Rotator Cuff Repairs, 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, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers Knee: Cruciate Ligament Repair, 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, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

Device Story

ExoShape™-XL is a bone fixation fastener used for securing soft tissue to bone. It serves as a line extension to the previously cleared ShapeLoc device. The device is implanted by surgeons during orthopedic procedures in the shoulder, foot/ankle, knee, hand/wrist, and elbow. It functions as an interference fixation device to provide mechanical stability for soft tissue repairs. The device is intended to facilitate healing by maintaining tissue-to-bone contact. Clinical benefit is derived from the secure fixation of ligaments and tendons during the post-operative recovery period.

Clinical Evidence

Bench testing only. Performance was evaluated using monotonic soft tissue fixation strength testing and dimensional verification in Sawbone® and porcine bone analogues to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Interference fixation device; non-degradable bone fixation fastener. Technological characteristics are equivalent to the ShapeLoc predicate. Device is a line extension offering additional sizes.

Indications for Use

Indicated for fixation of soft tissue to bone in shoulder, foot/ankle, knee, hand/wrist, and elbow surgical procedures, including ligament reconstructions, tendon repairs, 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

• ShapeLoc Interference Fixation Device (K101808)
• Parcus Medical PEEK CF Interference Screw (K091093)
• Arthrex® Interference Screw (K062466)

Submission Summary (Full Text)

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### MEDSHAP SOLUTIONS

JUN 1 0 2011

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Special 510(k) Page 9 of 144

# Special 510(k) Summary

Special 510(k) Number:

Date Prepared:

May 26, 2011

KIII471

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

- A. Submitter: MedShape Solutions, Inc. (MSS) 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318 Registration #10026693
- B. Company Contact: Jack Griffis Vice President, Research & Development [phone] (direct) [phone] (fax) [e-mail]
- ். Device Information: Trade Name: Common Name:

ExoShape™-XL Interference Fixation Device Fastener, Fixation, bone, non-degradable

- D. Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue HWC/MBI 21 CFR 888.3040
- E. Predicate Device(s): MSS, ShapeLoc Interference Fixation Device, K101808 Parcus Medical PEEK CF Interference Screw, K091093 Arthrex® Interference Screw, K062466

#### F. Labeling and Intended Use:

No substantive changes to the labeling or Instructions for Use have been made to the submitted information of the MedShape predicate per K101808.

The proposed ExoShape™-XL Interference Fixation Device has the same intended uses as the previously cleared predicate device per K101808. As such, both devices are indicated for fixation of 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 or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers

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Knee: Cruciate Ligament Repair, 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 Reconstruction, Ligament Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

- ு. Substantial Equivalence Summary:
The ExoShape™-XL Interference Fixation Device is a line extension offering additional sizes within the current cleared product line and is substantially equivalent to the ShapeLoc (original product name) Soft Tissue Fastener, cleared under K101808. The technological characteristics of the ExoShape™-XL and the ShapeLoc Interference Fixation Devices are equivalent. It is important to note that the ShapeLoc product name was changed to ExoShape™ after clearance, and the two names are considered interchangeable.

In addition, the ExoShape™-XL is substantially equivalent to the original predicate Arthrex® Interference Screw, cleared under K062466 and the additional predicate Parcus Medical PEEK CF Interference Screw, cleared under K091093. Any differences between the ExoShape™-XL Interference Fixation Device and the listed predicates ShapeLoc, Arthrex® or Parcus Medical Interference Screw Devices are considered minor and do not raise questions concerning safety and effectiveness.

Functional performance testing was conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength and other dimensional verification. Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the listed devices. Based on the information submitted, MedShape Solutions, Inc. has determined that the proposed ExoShape™-XL Interference Fixation Device is substantially equivalent to the currently marketed device.

A

Jack Griffis 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, sans-serif font on the top line. Underneath the first word is a horizontal line, and below that is the word "SOLUTIONS" in a smaller, sans-serif font. The text is black on a white background.

1575 Northside Drive, Suite 440 Atlanta, GA 30318 404-249-9155 phone [phone] fax

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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 depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

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

JUN 10 2011

Re: K111471

Trade/Device Name: ExoShape™-XL Interference Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: May 26, 2011 Received: May 27, 2011

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

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Page 2 - Mr. Jack Griffis

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin L Keith

Jr 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:

Device Name: ExoShape™-XL Interference Fixation Device

### Indications for Use:

The MedShape Solutions, Inc., ExoShape™-XL Interference Fixation Device is intended for fixation of soft tissue to bone in the following procedures:

- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Foot/Ankle: Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
- Knee: Cruciate Ligament Repair, 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. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Liqament Reconstructions and Repairs and Tendon Transfers
- Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

D/OR
Over
(21 C

Over-The-Counter Use (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)


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

| 510(k) Number | K111471 |
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