The MedShape, Inc., Porous Morphix® Suture Anchor with Force Fibere is intended for fixation of suture to bone in the shoulder, footlankle, knee, hand/wrist and elbow in the following procedures:

Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Shoulder: Biceps 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
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Ulnar Collateral Ligament Scapholunate Ligament Reconstruction, Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral Ligament Reconstruction

Device Description

The proposed Porous Morphix® Suture Anchor with Force Fiber® Suture is a line extension to our Morphix® product family and is substantially equivalent to the Morphix® Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, in which the features and intended uses are the same. In addition, the technological characteristics of the Morphix® and the Porous Morphix® Suture Anchor are equivalent. Differences between the Porous Morphix® Suture Anchor and the MedShape predicate Morphix® Suture Anchor include an extruded porous layer on the top surface of the device and a change in the preferred suture supplier (suture supplier CP Medical, previously cleared under K041894, was switched to suture supplier Teleflex Medical, previously cleared under K033654). This porous surface is derived directly from the implant body and is not a sintered coating.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Porous Morphix® Suture Anchor with Force Fiber® Suture. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically associated with AI/ML device performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MedShape, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture - now referred to as Morphix®, K091202) based on:

Same Intended Uses: The new device has the same indications for use as the predicate.
Equivalent Technological Characteristics: Analysis of non-clinical test results (monotonic and post cyclic suture fixation strength in Sawbone® bone analogue [pull-to-failure], dimensional verification, and material safety data [both bio and MRI compatibility]) supports this equivalence.
Minor Differences: The differences are an extruded porous layer on the top surface of the device and a change in suture supplier. These differences were determined not to raise questions concerning safety and effectiveness.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method.
MRMC comparative effectiveness study.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

These points are relevant to AI/ML device validation, which is a different regulatory pathway and type of study than what is presented in this 510(k) summary for a physical medical device (suture anchor).

Summary

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Image /page/0/Picture/0 description: The image shows the MedShape logo. The logo consists of a stylized letter "M" with a square on top, followed by the word "MEDSHAPE" in a bold, sans-serif font. The logo is black and appears to be on a white background.

K130467 (1/2)

Traditional 510(k) Page 11 of 81

510(k) Summary

510(k) Number: K130467

Date of Original Submission: February 2200, 2013

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

A. Submitter: MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318 Registration #10026693
DEC 0 5 2013
B. Company Contact: Kenneth Dupont, Ph.D. Technology Associate/Project Leader, Research & Development (678) 235-3336 (direct) (404) 249-9158 (fax) kenneth.dupont@medshape.com
். Device Information: Porous Morphix® Suture Anchor with Force Fiber® Suture Trade Name: Common Name: Suture Anchor
D. Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue MBI 21 CFR 888.3040
Li Predicate Device(s): MedShape, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture - now referred to as Morphix®, K091202
E. Labeling and Intended Use: NOTE: Draft labels and instructions for use can be found in Attachment D.

The proposed Porous Morphix® Suture Anchor with Force Fiber® Suture has the same intended uses as our previously cleared predicate device in K091202. 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:

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

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K130467 (2/2)

Image /page/1/Picture/1 description: The image shows the logo for Medshape. The logo consists of a stylized letter "M" with a square on top, followed by the word "MEDSHAPE" in block letters. The logo is in black and white.

Traditional 510(k) Page 12 of 81

Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair, Hallux Valqus 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 Reconstruction, Collateral Ligament Radial Ligament Reconstruction
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial collateral Ligament Reconstruction
G. Substantial Equivalence Summary:

The proposed Porous Morphix® Suture Anchor with Force Fiber® Suture is a line extension to our Morphix® product family and is substantially equivalent to the Morphix® Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, in which the features and intended uses are the same. In addition, the technological characteristics of the Morphix® and the Porous Morphix® Suture Anchor are equivalent. Analysis of non-clinical test results (monotonic and post cyclic suture fixation strength in Sawbone® bone analogue [pull-to-failure], dimensional verification, and material safety data [both bio and MRI compatibility]) supports the conclusion that the proposed device is substantially equivalent to the predicate device. Shear strength of the layer/implant body interface was also measured,

Differences between the Porous Morphix® Suture Anchor and the MedShape predicate Morphix® Suture Anchor include an extruded porous layer on the top surface of the device and a change in the preferred suture supplier (suture supplier CP Medical, previously cleared under K041894, was switched to suture supplier Teleflex Medical, previously cleared under K033654). This porous surface is derived directly from the implant body and is not a sintered coating. Based on the information submitted, MedShape, Inc. has determined that these differences do not raise questions concerning safety and effectiveness and that the proposed Porous Morphix® Suture Anchor is substantially equivalent to the currently marketed device.

12/04/2013

Kenneth Dupont, Ph.D. Technology Associate/Project Leader, Research & Development

1575 Northside Drive, NW, Suite 440, Atlanta, GA 30318 404-249-9155 phone 404-249-9158 fax

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

December 5, 2013

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

MedShape. Incorporated Kenneth DuPont, Ph.D. Technology Associate/Project Leader 1575 Northside Drive Northwest, Suite 440 Atlanta, Georgia 30318

Re: K130467

Trade/Device Name: Porous Morphix® Suture Anchor with Force Fiber Suture® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 14, 2013 Received: October 15, 2013

Dear Dr. DuPont:

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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

ff your device is classified (see above) into either class II (Special Controls) or class 111 (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 - Kenneth DuPont, Ph.D.

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K130467

Device Name: Porous Morphix® Suture Anchor with Force Fiber Suture

Indications for Use:

The MedShape, Inc., Porous Morphix® Suture Anchor with Force Fibere is intended for fixation of suture to bone in the shoulder, footlankle, knee, hand/wrist and elbow in the following procedures:

Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Shoulder: Biceps 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
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Ulnar Collateral Ligament Scapholunate Ligament Reconstruction, Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral 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)

Page 1 of 1

Casey L. Hanley, Ph,D.

Division of Orthopedic Devices

Regulation Number and Section

N/A