WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES by MEDSHAPE SOLUTIONS

The MedShape Solutions, Inc., WedgeLoc™ 2.5mm 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, Achilies 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
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

Device Description

The proposed WedgeLoc™ 2.5mm Suture Anchor is an extension of sizes offered and is substantially equivalent to the WedgeLoc™ 180x Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, and the predicate Arthrex PushLock™ 2.5mm Suture Anchor, cleared under K063479, in which the basic features and intended uses are the same. In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ 2.5mm Suture Anchor are equivalent.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Suture). This type of document is a submission to the FDA (Food and Drug Administration) to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as existing products.

It is crucial to understand that 510(k) submissions, particularly for devices like suture anchors, typically do NOT include clinical studies or performance data comparing the device against acceptance criteria in the manner that AI/software as a medical device (SaMD) clearances do. For predicate-based devices, the focus is on demonstrating equivalence in design, materials, manufacturing processes, and sometimes non-clinical performance (e.g., mechanical testing) to an already cleared device. Clinical efficacy is generally inferred from the predicate device's history of safe and effective use.

Therefore, the specific information requested in the prompt, such as acceptance criteria based on accuracy metrics (sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, are not relevant or applicable to this type of device submission and are not found in the provided document.

The document discusses "substantial equivalence" based on:

Identical Intended Use: The device is indicated for the same types of procedures and anatomical locations as its predicate (K091202).
Similar Technological Characteristics: The proposed device is an "extension of sizes offered" and shares basic features with the predicate devices (K091202 and K063479).
Minor Differences: Any differences are considered minor and do not raise new questions of safety or effectiveness.

In summary, this document does not contain the information you've requested because it's a submission for a mechanical medical device (suture anchor) demonstrating substantial equivalence to a predicate, not a software or AI-based device requiring clinical performance validation against specific accuracy metrics.

Summary

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MEDSHAPE
SOLUTIONS

DEC - 9 2009

Special 510(k) Page 9 of 88

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Special 510(k) Summary

Special 510(k) Number: K092914

September 18th, 2009 Date Prepared:

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 (404) 583-6889 (cell) (404) 249-9158 (fax) Jack. Griffis@MedShapeSolutions.com
C. Device Information: Trade Name: WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Suture Common Name: Suture Anchor
Fastener, Fixation, Non-degradable, Soft Tissue D. Classification Name: HWC/MBI 21 CFR 888.3040
E. Predicate Device(s): MSS, WedgeLoc™ 180x Suture Anchor with Opti-Fiber™ Suture, K091202 Arthrex PushLock™ 2.5mm Suture Anchor, K063479
E. Labeling and Intended Use: No changes to the labeling or Instructions for Use have been made to the submitted information of the MedShape predicate per K091202.

The proposed WedgeLoc™ 2.5mm Suture Anchor and Opti-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, Tenodesis. Acromio-Clavicular Separation Bicens Repair. Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

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

Any differences between the WedgeLoc™ 2.5mm Suture Anchor and the MedShape predicate WedgeLoc™ 180x or Arthrex PushLock™ Suture Anchor are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted. MedShape Sofutions. Inc. has determined that the proposed WedgeLoc™ 2.5mm Suture Anchor is substantially equivalent to the currently marketed device.

Jack Griffit 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. Below it, the word "SOLUTIONS" is in a smaller, sans-serif font. A line separates the two words.

1575 Northside Drive, Suite 440 Atlanta, GA 30318 404-249-9156 phone 404-249-9158 fax

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

DEC - 9 2009

MedShape Solutions c/o Mr. Jack Griffis Vice President. Research & Development 1575 Northiside Drive, Suite 440 Atlanta, Georgia 30318

Re: K092914

Trade/Device Name: WedgeLoc™ 2.5mm Suture Anchor and Opti-Fiber™ Sutures Regulation Number: 21 CFR 888.3040 . Regulation Name: Smooth or threaded metallic bone fixation fastner Regulatory Class: Class II Product Code:MBI, HWC Dated: November 16, 2009 Received: November17, 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 such 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); 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.fdaggov/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jonata Jr

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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: WedgeLoc™ 2.5mm Suture Anchor and Opti-Fiber™ Sutures

Indications for Use:

Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilies Tendon Repair, Hallux Foot/Ankle: 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
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

Prescription Use × (Part 21 CFR 801 Subpart D)

510(k) Number K092914

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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)

(Division Sign Off)	Page 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.