WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 by MEDSHAPE SOLUTIONS

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

Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Shoulder: Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: 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
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™ Suture Anchor is a sterile, single use, two piece "push-in" bone anchor. The suture anchor is designed to use the principles of compression to force the eyelet, pre-loaded with non-absorbable suture, into a hole created in the bone. The suture anchor body is comprised of a crosslinked Methyl methacrylate (MMA) polymer (comprised of Memori™ 7111. refer to MAF #1533) and PEEK eyelet (comprised of PEEK-OPTIMA® by Invibio®, refer to MAF #1209).

Each suture anchor is preloaded with two non-absorbable USP No. 2 sutures. The polyblend surgical suture provided with the proposed WedgeLoc™ Suture Anchor is provided by CP Medical, and has previously been cleared for market under K041894. In addition, these sutures meet USP requirements as described in the USP monograph for non-absorbable surgical sutures. Opti-Fiber™ non-absorbable polyblend surgical sutures are made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover and are identical to the CP-Fiber™ USP No. 2 sutures described in K041894.

AI/ML Overview

This is a 510(k) summary for a medical device called the WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures. This document aims to demonstrate substantial equivalence to predicate devices, rather than establishing primary safety and effectiveness through a traditional clinical study with defined acceptance criteria and performance reporting as one might expect for a novel device.

The "study" referenced in this document is an in-vitro functional performance testing to show the new device performs at least as well as the predicate.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a quantitative table for "device performance." Instead, it relies on demonstrating that the proposed device performs "as well as or better than" the predicate device in functional performance testing.

Acceptance Criteria	Reported Device Performance
Functional performance in-vitro as well as or better than predicate device (qualitative)	"Analysis of the results substantiates the statement that the proposed device performs as well as or better than the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "functional performance testing," but the number of samples or tests conducted is not provided.
Data Provenance: In-vitro (laboratory testing, not human or animal data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for this type of test is typically based on engineering specifications and direct measurement of mechanical properties, rather than expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. This was an in-vitro functional test, not a study requiring adjudication of expert opinions or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

No MRMC comparative effectiveness study was done. This document describes the 510(k) submission for a medical device (suture anchor), not an AI or imaging device that would typically involve MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used

The ground truth for the in-vitro functional performance testing would be the measured mechanical properties of the suture anchor and its fixation strength in bone analogues, compared against the known performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device submission.

Summary

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510(k) Page __________________________________________________________________________________________________________________________________________________________________ of ___________________________________________________________________________________________________________________________________________________________________________

510(k) Summary

K083792 510(k) Number:

March 18th, 2008 Date Prepared:

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

Submitter: A. MedShape Solutions, Inc. 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
். Preparer: Max Sherman Sherman Consulting Services, Inc. 339 East Wildwood Drive Warsaw, Indiana 46580 (574) 269-1928 (direct) (574) 267-3845 (fax)
Device Information: D. WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures Trade Name: Suture Anchor Common Name:
Fastener, Fixation, Non-degradable, Soft Tissue E. Classification Name: HWC/MBI and GAT 21 CFR 888.3040
. F. Predicate Device(s): Arthrex PushLock™ suture anchor, K051219 Arthrex FiberWIRE™ polyblend suture, K021434

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G. Physical Description:
The proposed WedgeLoc™ Suture Anchor is a sterile, single use, two piece "push-in" bone anchor. The suture anchor is designed to use the principles of compression to force the eyelet, pre-loaded with non-absorbable suture, into a hole created in the bone. The suture anchor body is comprised of a crosslinked Methyl methacrylate (MMA) polymer (comprised of Memori™ 7111. refer to MAF #1533) and PEEK eyelet (comprised of PEEK-OPTIMA® by Invibio®, refer to MAF #1209).

H. Indications for Use:
The WedgeLoc™ Suture Anchor and Opti-Fiber™ sutures are indicated for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Shoulder: 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 Collateral Ligament Reconstruction, Radial Ligament Reconstruction
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial collateral Ligament Reconstruction

Image /page/1/Picture/12 description: The image shows the logo for MEDSHAPE. The word "MEDSHAPE" is in large, bold, black letters. Underneath "MEDSHAPE" is the word "SOLUTIONS" in smaller, thinner, black letters.

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K083792(pg 3/3)

510(k) Page ______________ of_

l. Comparison of Technological Characteristics: The WedgeLoc™ Suture Anchor and Opti-Fiber™ sutures are substantially equivalent in design, function and intended use to the following predicate devices:

Arthrex PushLock™ suture anchor, K051219 Arthrex FiberWIRE™ polyblend suture, K021434

Both suture anchors are comprised of a two part assembly; main body and evelet. The evelets of both suture anchors are made from PEEK-OPTIMA® material. The main body of the proposed WedgeLoc™ Suture Anchor differs from the predicate device as it is comprised of a cross-linked Methyl methacrylate (MMA) (Memori™ 7111) instead of PEEK-OPTIMA® material. The Memori™ 7111 has successfully passed biocompatibility screening in compliance with ISO 10993:2003 Biological evaluation of medical devices (refer to MAF #1533). Both anchors are deployed using a "push in" or "tap in" process for securing their polyblend sutures into bone. Both suture anchors have the same indications for use.

Both predicate and proposed Opti-Fiber™ sutures are indicated for use in soft tissue approximation; both meet USP for non-absorbable sutures, may be silicone coated or uncoated, and may be dyed or undyed with an appropriate FDA listed color additive. The proposed Opti-Fiber™ suture has previously been cleared for market as per K041894.

Functional performance testing was conducted in-vitro. This testing was conducted in both cancellous and cortical bone analogues. Analysis of the results substantiates the statement that the proposed device performs as well as or better than the predicate device.

Jack Griffis Vice President, Research & Development

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 2 5 2009

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

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

Re: K083792

Trade/Device Name: WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic fixation fastener Regulatory Class: II Product Code: HWC, MBI, GAT Dated: March 18, 2009 Received: April 12, 2009

Dear Mr. Griffis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications felerenced above and nave acterificated predicate devices marketed in interstate 101 use stated in the encreate) to regary che enactment date of the Medical Device Amendments, or to commence provide to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosment Acr (Act) that to not required to the general controls provisions of the Act. The r ou may, merciole, market the device, boojes resuirements for annual registration, listing of general Controls provisions of the rist 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 II your device is classified (soc above) into Existing major regulations affecting your device can may be subject to such additional oblines - Lifeting and to 898. In addition, FDA may be found in the Gode acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that TDA has made a determination administered by other Federal agencies. You must or any Federal statutes and regulations daminities or registration and listing (21 comply with an the Act 3 requirements, n.v., good manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 820); and if applicable, the electronic a forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jack Griffis

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For Peter D. Rummell

Mark N. Melkerson ) 0 ( Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Page ___ of _

Indications for Use

510(k) Number: K083792

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

Indications for Use:

Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Shoulder: Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: 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
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)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

(k) Number	14083792
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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.