Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator Duff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Device Description

The Opus Labral.ock™ P device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

AI/ML Overview

This 510(k) premarket notification is for the Opus LabraLock P Knotless Fixation Device. The document indicates that the device is substantially equivalent to existing predicate devices, primarily differing in the material used (PEEK instead of stainless steel). This submission focuses on demonstrating equivalence through material characterization and comparison to predicate devices, rather than an extensive clinical study to establish new performance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is largely not applicable in the context of this specific 510(k) submission, which relies on demonstrating equivalence to previously cleared devices.

However, based on the information provided, here's what can be inferred or stated about the device and its assessment for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The primary acceptance criterion for this 510(k) is "substantial equivalence" to predicate devices. This means the device must have the same intended use and technical characteristics as the predicate, or if it has different technological characteristics, it must be demonstrated to be as safe and effective as the predicate. The key characteristic change here is the material (PEEK vs. stainless steel).
Reported Device Performance: The document states, "The differences between the Opus® LabraLock™ P and the predicate devices do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices." This is a qualitative statement of performance, asserting equivalence based on material characterization and comparison to predicate devices. No specific quantitative performance metrics (e.g., tensile strength, pull-out force) or their corresponding acceptance criteria are explicitly detailed in the provided text.

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

Not Applicable. This 510(k) notification does not describe a "test set" in the context of a clinical performance study with human or animal subjects for this specific device. The assessment is based on the substantial equivalence principle, relying on existing knowledge of predicate devices and material properties.

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

Not Applicable. As no clinical "test set" or ground truth requiring expert consensus is described for this specific device's performance evaluation, this information is not relevant to this submission. Regulatory bodies like the FDA review the submission based on provided data, but "experts" in the sense of adjudicating clinical outcomes are not mentioned here.

4. Adjudication Method:

Not Applicable. As no clinical "test set" requiring adjudication for performance outcomes is described, this information is not relevant.

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

No. An MRMC study is typically for evaluating the diagnostic or prognostic performance of an imaging or AI device. This device is a bone anchor, a surgical implant, and such a study is not applicable to its regulatory clearance.

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

Not Applicable. This question pertains to AI/algorithm performance. The device is a physical bone anchor, not an algorithm.

7. The Type of Ground Truth Used:

Substantial Equivalence: The "ground truth" here is the established safety and effectiveness of the predicate devices. The new device's safety and effectiveness are established by demonstrating that its characteristics (primarily the change in material to PEEK) do not raise new questions of safety or effectiveness compared to the already cleared predicate devices. Material characterization and potentially bench testing data (though not detailed here) would support this claim.

8. The Sample Size for the Training Set:

Not Applicable. As this is not an AI/ML device, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As this is not an AI/ML device, this question is not relevant.

In summary: This 510(k) submission for the Opus LabraLock P Knotless Fixation Device primarily relies on demonstrating substantial equivalence to predicate devices, particularly given a material change from stainless steel to PEEK. The regulatory review focuses on whether this change introduces new safety or effectiveness concerns, rather than requiring extensive de novo clinical performance studies that would generate the kind of data requested in your prompt. The provided text confirms the FDA's agreement with the substantial equivalence claim.

Summary

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Ko61349 page 4 of 2

510(K) SUMMARY

JUL 1 4 2006

ARTHROCARE CORPORATION OPUS LABRALOCK P KNOTLESS FIXATION DEVICE

General Information

Submitter Name/Address:	ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-3523
Establishment Registration No.:	2951580
Contact Person:	Laura N. KasperowiczSr. Manager, Regulatory Affairs
Date Prepared:	May 12, 2006
Device Description
Trade Name:	Opus® LabraLock™ P
Generic/Common Name:	Bone Anchor, Fastener, Fixation, Soft Tissue
Classification Name:	Fastener, Fixation, Nondegradeable, Soft Tissue(Class II per 21 CFR 888.3040, Product code: MBI)
Predicate Devices
	Opus MiniMagnum K042584 (Cleared 12/14/04)Mitek Mini QuickAnchor Plus K992487 (Cleared 09/21/99)Arthrex PEEK Pushlock K051219 (Cleared 09/27/05)Mitek Bioknotless Anchor K002639 (Cleared 05/11/01)

Product Description

The Opus Labral.ock™ P device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

Indications For Use

The Opus LabraLock™ P bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

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510(K) SUMMARY

Substantial Equivalence

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The Opus® Labral.ock™ P is substantially equivalent to the existing Opus® MiniMagnum™ Knotless Firation Device cleared by the Food & Drug Administration [K042584], the Mitek Mini QuickAnchor™ Plus [K992487], the Mitek Bioknotless™ Anchor [K002639] and the Arthrex PEEK™ PushLock™ Knotless Anchor [K051219]. The differences between the Opus® LabraLock™ P and the predicate devices do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices.

Summary and Reason for 510k Notification

The purpose of this 510k is to notify the Food and Drug Administration of a new product, the Opus® LabraLock™ P Knotless Fixation Device. This new product is substantially equivalent to the Opus® MiniMagnum™ Knotless Fixation Device originally cleared under K042584, but is manufactured from PEEK (polyether-etherketone) as opposed to stainless steel.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 14 2006

ArthroCare Corporation % Ms. Laura N. Kasperowicz Sr. Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Re: K061349

Trade/Device Name: Opus® LabraLock™ P Knotless 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 12, 2006 Received: May 15, 2006

Dear Ms. Kasperowicz:

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 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 - Ms. Laura N. Kasperowicz

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

uberg Buchup
to

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

Enclosure

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page 1 of 1

INDICATIONS FOR USE STATEMENT

510(k) Number:

KO61349

Device Name:

Opus® LabraLock™ P 'Knotless Fixation Device

Indications for Use:

The Opus® LabraLock™ P bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

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

Saiba Kucind & Kim

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K061349

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.