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

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

Device Description

WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures

AI/ML Overview

This document, K091202, is a Special 510(k) summary for the MedShape Solutions WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures. It asserts substantial equivalence to a previously cleared device (K083792) and other predicate devices, rather than detailing a new study with specific acceptance criteria and performance data for the 180X model itself.

Therefore, many of the requested categories for a new clinical study are not directly applicable or available in this submission. This 510(k) is primarily focused on demonstrating that the minor changes to the WedgeLoc™ suture anchor (the "180X" designation) do not raise new questions of safety and effectiveness, and thus do not require new acceptance criteria or a dedicated study for the device's performance against such criteria.

Here's the breakdown of what can be extracted from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance against such criteria are provided for the WedgeLoc™ 180X Suture Anchor in this document. The submission argues for substantial equivalence based on the predicate device's established performance and the minor nature of the changes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This 510(k) does not describe a new clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This 510(k) does not describe a new clinical study with a test set and ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This 510(k) does not describe a new clinical study with a test set and adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical implant (suture anchor), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical implant (suture anchor), not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. This 510(k) does not describe a new study that required ground truth establishment. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This 510(k) does not describe a machine learning model or a training set.

9. How the ground truth for the training set was established

Not applicable. This 510(k) does not describe a machine learning model or a training set.

Summary of the document's content relevant to acceptance criteria and study:

The core of this Special 510(k) is the assertion that the WedgeLoc™ 180X Suture Anchor is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K083792) and the Arthrex PushLock™ Suture Anchor (K051219).

Acceptance Criteria: The implied "acceptance criteria" for this Special 510(k) are that the minor differences between the new device and its predicates do not raise new questions concerning safety and effectiveness. This is a regulatory acceptance criterion for the submission itself, not a performance criterion for the device in a clinical study.
Study That Proves the Device Meets Acceptance Criteria: The "study" isn't a new clinical trial but rather a comparative analysis of the technological characteristics of the WedgeLoc™ 180X Suture Anchor against its predicate devices. The document states:
- "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."

In essence, the "proof" is the argument of substantial equivalence based on a comparison of features, intended use, and technological characteristics, rather than new device-specific performance data. The device's performance is accepted as equivalent to the already cleared predicate devices.

Summary

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K091202 (pg 1/2)

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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 (404) 249-9156 x11 (direct) (404) 249-9158 (fax) Jack.Griffis@MedShapeSolutions.com
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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 (800) 638-2041 or (240) 276-3150 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:

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

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.