EZStart Interference Screw

K182955 · Conmed Corporation · HWC · Jan 22, 2019 · Orthopedic

Device Facts

• Record ID: K182955
• Device Name: EZStart Interference Screw
• Applicant: Conmed Corporation
• Product Code: HWC · Orthopedic
• Decision Date: Jan 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EZ Start™ Interference Screws are intended for use in bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

Device Story

EZStart™ Interference Screw is a dual-threaded, cannulated titanium bone screw; designed for orthopedic surgeons to maintain fixation of bone-tendon-bone grafts during ACL and PCL knee reconstruction. Device features tapered tip for insertion into bone tunnels; cannulation allows guidewire-assisted placement. Used in clinical/OR settings; provides mechanical fixation to facilitate graft healing. Benefits include secure graft attachment to bone, supporting ligament reconstruction.

Clinical Evidence

Bench testing only. Verification testing included insertion torque, fixation strength, sterilization, biocompatibility, pyrogenicity (LAL method, <0.5 EU/mL), shelf-life, post-aging functional testing, transportation, and MR safety. Validation testing included device user and packaging/labeling validation.

Technological Characteristics

Material: Titanium. Design: Cannulated, dual-threaded, tapered tip. Dimensions: 15mm–30mm length, 6mm–10mm diameter. Energy source: None (mechanical). Sterilization: Gamma radiation.

Indications for Use

Indicated for bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in ACL and PCL reconstruction of the knee. Contraindications: insufficient bone quantity/quality; blood supply limitations/previous infections; foreign-body sensitivity; active sepsis/infection; conditions limiting patient ability/willingness to restrict activity or follow post-op directions.

Regulatory Classification

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.

Predicate Devices

• Concept Cannulated Interference Screw (K933352)

Reference Devices

• Guardsman® Interference Screws (K960962)

Submission Summary (Full Text)

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January 22, 2019

ConMed Corporation Jeremy Walter Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K182955

Trade/Device Name: EZStart™ Interference Screw Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 22, 2018 Received: October 24, 2018

Dear Mr. Walter:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Laurence D. Coyne -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | | |
| <b>Indications for Use</b> | | |
| 510(k) Number (if known) | K182955 | Page 1 of 1 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. |
| Device Name | EZStart™ Interference Screw | |
| Indications for Use (Describe) | | |
| Intended Use | EZ Start™ Interference Screws are intended for use in bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee. | |
| Indications for Use | EZ Start™ Interference Screws are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee. | |
| Type of Use (Select one or both, as applicable) | | |
| <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. | |

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Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside on the left. To the right of the square is the word "CONMED" in black, with the word "CORPORATION" in smaller black letters underneath.

### 510(k) SUMMARY

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K182955.

#### I. SUBMITTER

CONMED Corporation 11311 Concept Blvd Largo, Florida 33773

Phone: [phone] Fax: [phone]

Contact Person: Jeremy Walter Date Prepared: December 21, 2018

#### II. DEVICE NAME

| Device Name: | EZStart™ Interference Screw |
|----------------------|-------------------------------------|
| Common Name: | Bone Screw |
| Classification Name: | Screw, Fixation, Bone |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3040 |
| Product Codes: | HWC |

#### III. PREDICATE/ LEGALLY MARKETED DEVICE

| Device Name: | Concept Cannulated Interference Screw |
|---------------|---------------------------------------|
| Company Name: | Linvatec Corporation |
| 510(k) #: | K933352 |

#### IV. REFERENCE DEVICE

| Device Name: | Guardsman® Interference Screws |
|---------------|--------------------------------|
| Company Name: | Linvatec Corporation |
| 510(k) #: | K960962 |

#### V. DEVICE DESCRIPTION

The EZStart™ Interference Screw is a dual threaded titanium interference screw with a tapered tip for easy insertion into bone. The screw is cannulated to allow a guidewire through to assist with placement of the screw into the bone tunnel. The screw is used to maintain the fixation of bone - tendon - bone grafts in orthopedic procedures. The device is Gamma Sterilized.

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Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white abstract shape inside, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, also in black. A thin blue line separates the two words.

#### VI. INTENDED USE/ INDICATIONS FOR USE

### Intended Use:

EZ Start™ Interference Screws are intended for use in bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

### Indications for Use

EZ Start™ Interference Screws are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

### COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE

The following table represents a summary of the technological characteristics between the proposed and the predicate device.

| | EZStart™ Interference Screw<br>Proposed Device | Concept Cannulated Interference Screw<br>Predicate Device |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Device<br>Description | A sterile cannulated titanium<br>interference bone screw. | Same |
| Intended Use | Intended for use in bone - tendon -<br>bone graft fixation in anterior<br>cruciate ligament (ACL) and<br>posterior cruciate ligament (PCL)<br>reconstruction of the knee. | Same, excluding PCL. |
| Indication for Use | Used to provide bone fixation in<br>orthopedic procedures, including<br>bone-tendon-bone graft fixation in<br>anterior cruciate ligament (ACL)<br>and posterior cruciate ligament<br>(PCL) reconstruction of the knee. | Same, excluding PCL. |
| Contraindications | 1. Insufficient quantity or quality<br>of bone for attachment.<br>2. Blood supply limitations and/or<br>previous infections which may<br>retard healing.<br>3. Foreign-body sensitivity -<br>where material sensitivity is<br>suspected, appropriate tests<br>should be made and sensitivity<br>ruled out prior to implantation.<br>4. Patients with active sepsis or<br>Infection.<br>5. Conditions which tend to limit<br>the patient's ability or<br>willingness to restrict activities<br>or follow directions during the<br>healing period. | Same |
| Device<br>Dimensions | Lengths: 15mm – 30mm<br>Diameters: 6mm -10mm | Same, excluding 15 mm lengths and<br>10 mm diameters. |
| Technological<br>Characteristics | Metallic dual-threaded screw-in<br>design | Same |

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Image /page/5/Picture/0 description: The image shows the Conmed Corporation logo. The logo consists of a blue square with a white curved shape inside, followed by the word "CONMED" in black, with the word "CORPORATION" in smaller black letters underneath. The logo is simple and modern, and the colors are clean and professional.

## VIII. PERFORMANCE DATA

Testing has been completed to demonstrate that the EZStart™ Interference Screw performs as intended and is substantially equivalent to the predicate device.

Completed testing includes the following:

Verification Testing

- Insertion Torque
- Fixation Strength ●
- Sterilization ●
- Biocompatibility
- Pyrogenicity ●
- Shelf-life ●
- Post Aging Functional ●
- Transportation ●
- MR Safety ●

Validation Testing

- Device User Validation
- Packaging/Labeling User Validation

Pyrogenicity testing was conducted using a Limulus Amebocyte Lysate (LAL) method with results that met the current FDA and USP requirements, < 0.5 EU/mL and < 20 EU/device, respectively.

### IX. CONCLUSION

The EZStart™ Interference Screw is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate Concept Cannulated Interference Screw. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the EZStart™ Interference Screw is substantially equivalent to the Concept Cannulated Interference Screw (K933352).