The ConMed Linvatec Soft Tissue to Bone System is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Device Description

The ConMed Linvatec Soft Tissue to Bone System includes anchors in a range of sizes and materials from 3.5 mm to 6.5 mm diameter and 15 mm to a 17 mm length with one (1) to three (3) non-absorbable suture configurations. The anchor sizes correspond to a series of general surgical instruments such as; bone taps, bone punches, drivers, and a suture passer.

AI/ML Overview

This 510(k) premarket notification for the ConMed Linvatec Soft Tissue to Bone System indicates that substantial equivalence was demonstrated without a clinical study. The submission focuses on comparing the new device to legally marketed predicate devices based on design, manufacturing materials, intended use, principles of operation, and technical characteristics.

Therefore, many of the requested categories related to clinical study design and performance metrics cannot be filled.

Here's a breakdown of the available information:

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

Acceptance Criteria	Reported Device Performance
Not Applicable (No specific performance criteria tied to a clinical study are mentioned in this 510(k). The focus is on substantial equivalence to predicates based on design and materials.)	Substantially equivalent to predicate devices (LM Bone Anchor, ThRevo® Anchor, ConMed Linvatec Bio Mini-Revo®) in design, manufacturing materials, intended use, principles of operation, and technical characteristics.

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. No clinical test set data is provided in this 510(k) submission.

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. No clinical test set data or ground truth establishment by experts is mentioned.

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

Not Applicable. No clinical test set, and therefore no adjudication, is mentioned.

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 (soft tissue to bone system), not an AI diagnostic tool. No MRMC study was performed.

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

Not Applicable. This device is a medical implant, not an algorithm or AI system.

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

Not Applicable. No clinical ground truth was established for this submission, as it relies on substantial equivalence to predicates.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this device's submission, as it is a physical implant and not an AI or algorithm-based device.

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

Not Applicable. As there is no training set, there is no ground truth establishment for one.

Summary of Device and Acceptance:

The ConMed Linvatec Soft Tissue to Bone System is a nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures. The acceptance of this device by the FDA (as indicated by the 510(k) clearance K091549) was based on its substantial equivalence to three legally marketed predicate devices:

LM Bone Anchor (renamed ConMed Linvatec Ultrafix RC®) (K963812)
ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures (K073481)
ConMed Linvatec Bio Mini-Revo® (K053561)

The FDA determined that the new device is substantially equivalent to these predicates in its design, manufacturing materials, intended use, principles of operation, and technical characteristics. Therefore, no new clinical studies or performance data were required or submitted to demonstrate its safety and effectiveness beyond this comparison to already cleared devices.

Summary

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510(k) SUMMARY ConMed Linvatec Soft Tissue to Bone System

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number K091549.

A. Submitter

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

JUN 23 2009

B. Company Contact

John Cusack Regulatory Affairs Specialist (727) 399-5562 Telephone FAX (727) 399-5264

C. Device Name

Trade Name: Common Name: Classification Name: Proposed Class/Device: Product Code: Regulation:

ConMed Linvatec Soft Tissue to Bone System Nonabsorbable suture anchor system Fastener, Fixation, Nondegradable, Soft tissue Class II MBI 21 CFR Part 888.3040

D. Predicate/Legally Marketed Devices

Device Name:	LM Bone Anchor (renamed ConMed Linvatec Ultrafix RC®)
Company Name:	Li Medical Technologies Inc (purchased by ConMed Linvatec)
510(k) #:	K963812
Device Name:	ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures
Company Name:	ConMed Linvatec
510(k) #:	K073481
Device Name:	ConMed Linvatec Bio Mini-Revo®
Company Name:	ConMed Linvatec
510(k) #:	K053561

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E. Device Description

F. Intended Use/ Indications

G. Substantial Equivalence

The ConMed Linvatec Soft Tissue to Bone System is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

JUN 23 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ConMed Linvatec Corporation c/o Mr. John Cusack 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K091549

Trade/Device Name: ConMed Linvatec Soft Tissue to Bone System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 26, 2009 Received: May 27, 2009

Dear Mr. Cusack:

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. Ilsting 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); 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 - Mr. Cusack

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.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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchup

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 (if known):

Device Name: ConMed Linvatec Soft Tissue to Bone System

Indications for Use:

Prescription Use X AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buehrig

Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091549

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.