2.8 mm/3.3 mm PopLok Suture Anchors
Device Facts
| Record ID | K181120 |
|---|---|
| Device Name | 2.8 mm/3.3 mm PopLok Suture Anchors |
| Applicant | Conmed Corporation |
| Product Code | MBI · Orthopedic |
| Decision Date | Dec 21, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PopLok™ Suture Anchor 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 suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate immobilization, throughout the healing period.
Device Story
PopLok Suture Anchors are sterile, single-use orthopedic implants designed to reattach soft tissue (ligaments, tendons, joint capsules) to bone. Manufactured from PEEK Optima LT1, the anchors are available in 2.8 mm and 3.3 mm diameters and come preloaded on a disposable driver. Used by orthopedic surgeons in either arthroscopic or open surgical procedures, the device is deployed into bone to provide a secure anchor point for sutures. Once the anchor is set, the surgeon uses the attached #2 or #0 Hi-Fi sutures to secure the damaged soft tissue. This stabilization facilitates healing when combined with appropriate postoperative immobilization. The device functions as a mechanical fixation fastener, providing immediate structural support to the repair site.
Clinical Evidence
Bench testing only. No clinical data provided. Performance verification included reliability, ultimate fixation strength, cyclic testing, sterilization, pyrogen/bacterial endotoxin testing, biocompatibility, and shelf-life. Validation testing included user validation, packaging, and transportation studies.
Technological Characteristics
Materials: PEEK Optima LT1 (polyetheretherketone). Form factor: 2.8 mm or 3.3 mm diameter anchors. Components: Anchor, disposable driver, threader, #2 or #0 Hi-Fi sutures. Principle: Mechanical bone fixation fastener. Sterilization: Sterile, single-use.
Indications for Use
Indicated for patients requiring soft tissue-to-bone reattachment in orthopedic procedures (arthroscopic or open), including ligaments, tendons, or joint capsules. Contraindicated in patients with poor bone/soft tissue quality, physical conditions preventing healing or activity restriction, foreign body sensitivity, or for posterior spinal pedicle fixation.
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
- ConMed Linvatec Soft Tissue to Bone System (K091549)
Submission Summary (Full Text)
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December 21, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ConMed Corporation Diana Nader-Martone Regulatory Affairs Specialist 525 French Road Utica. New York 13502
Re: K181120
Trade/Device Name: 2.8 mm/3.3 mm PopLok Suture Anchors™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: November 21, 2018 Received: November 23, 2018
Dear Ms. Nader-Martone:
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 mav, 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 avare 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali -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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
### K181120
Device Name
2.8 mm/3.3 mm PopLokTM Suture Anchors
# Indications for Use (Describe)
### Intended Use
The PopLok™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
### Indications for Use
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 suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate immobilization, throughout the healing period.
8
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
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Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized blue and white graphic on the left, followed by the word "CONMED" in black, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in smaller, black letters.
### 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 K181120
#### I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5425 Fax: 727-399-5264
Contact Person: Diana L. Nader-Martone Date Prepared: April 26, 2018
#### II. DEVICE NAME
| Device Name: | 2.8 mm/3.3 mm PopLok™ Suture Anchors |
|----------------------|------------------------------------------------|
| Common Name: | Nonabsorbable Suture Anchor System |
| Classification Name: | Fastener, fixation, nondegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3040 |
| Product Codes: | MBI |
#### III. PREDICATE/ LEGALLY MARKET DEVICE
| Device Name: | ConMed Linvatec Soft Tissue to Bone System |
|---------------|--------------------------------------------|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K091549 |
#### IV. DEVICE DESCRIPTION
The 2.8 mm/3.3 mm PopLok™ Suture Anchors are sterile, single use devices. The 2.8 mm/3.3 mm PopLokTM Suture Anchors are manufactured from PEEK Optima LT1 (polyetheretherketone) material. The anchors are available in two (2) sizes (2.8 mm and 3.3 mm diameters). The anchors are supplied with one (1) #2 Hi-Fi® suture or two (2) #0 Hi-Fi® sutures, packaged separately. The anchors are provided sterile, single use and preloaded on a disposable driver with a threader.
#### INTENDED USE/ INDICATIONS FOR USE V.
The PopLok™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
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Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, curved shape inside on the left. To the right of the square is the word "CONMED" in a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.
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.
### COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | 2.8 mm/3.3 mm PopLok™ Suture Anchors<br>Proposed | ConMed Linvatec Soft Tissue to Bone System<br>(including PopLok™ Suture Anchors)<br>Predicate |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The 2.8 mm/3.3 mm PopLok™ Suture Anchors<br>are sterile, single use devices. The PopLok™<br>Suture Anchors are manufactured from PEEK<br>Optima LT1 (polyetheretherketone) material. The<br>anchors are provided sterile, single use and<br>preloaded on a disposable driver. The anchors<br>are available in two (2) sizes and four (4)<br>configurations. | The PopLok™ Suture Anchors are sterile, single<br>use devices. The PopLok™ Suture Anchors are<br>manufactured from PEEK Optima LT1<br>(polyetheretherketone) material. The anchors are<br>provided sterile, single use and preloaded on a<br>disposable driver. The anchors are available in<br>two (2) sizes and four (4) configurations. |
| Intended Use | The PopLok™ Suture Anchor is intended to<br>reattach soft tissue to bone in orthopedic surgical<br>procedures. | The PopLok™ Suture Anchor is intended to<br>reattach soft tissue to bone in orthopedic surgical<br>procedures. |
| Indication for Use | The system may be used in either arthroscopic or<br>open surgical procedures. After the suture is<br>anchored to the bone, it may be used to reattach<br>soft tissue, such as ligaments, tendons, or joint<br>capsules to the bone. The suture anchor system<br>thereby stabilizes the damaged soft tissue, in<br>conjunction with appropriate postoperative<br>immobilization, throughout the healing period. | The system may be used in either arthroscopic or<br>open surgical procedures. After the suture is<br>anchored to the bone, it may be used to reattach<br>soft tissue, such as ligaments, tendons, or joint<br>capsules to the bone. The suture anchor system<br>thereby stabilizes the damaged soft tissue, in<br>conjunction with appropriate postoperative<br>immobilization, throughout the healing period. |
| Contraindications | 1. Pathological conditions of bone which would<br>adversely affect the PopLok Knotless Suture<br>Anchor.<br>2. Pathological conditions in the soft tissue to be<br>repaired or reconstructed which would adversely<br>affect suture fixation.<br>3. Physical conditions that would eliminate, or<br>tend to eliminate, adequate implant support or<br>retard healing.<br>4. Conditions which tend to limit the patient's<br>ability or willingness to restrict activities or<br>follow directions during the healing period.<br>5. Attachment of artificial ligaments or other<br>implants.<br>6. Foreign body sensitivity, known or suspected<br>allergies to implant and/or instrument materials.<br>7. Do not use any other suture except for<br>ConMed Linvatec #2 and #0 HI-FI.<br>8. This device is not approved for screw<br>attachment or fixation to the posterior elements<br>(pedicles) of the cervical, thoracic or lumbar<br>spine. | 1. Pathological conditions of bone which would<br>adversely affect the PopLok Knotless Suture<br>Anchor.<br>2. Pathological conditions in the soft tissue to be<br>repaired or reconstructed which would adversely<br>affect suture fixation.<br>3. Physical conditions that would eliminate, or<br>tend to eliminate, adequate implant support or<br>retard healing.<br>4. Conditions which tend to limit the patient's<br>ability or willingness to restrict activities or<br>follow directions during the healing period.<br>5. Attachment of artificial ligaments or other<br>implants.<br>6. Foreign body sensitivity, known or suspected<br>allergies to implant and/or instrument materials.<br>7. Do not use any other suture except for<br>ConMed Linvatec #2 HI-FI.<br>8. This device is not approved for screw<br>attachment or fixation to the posterior elements<br>(pedicles) of the cervical, thoracic or lumbar<br>spine. |
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Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, stylized "C" inside on the left. To the right of the square, the word "CONMED" is written in a bold, sans-serif font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, sans-serif font, with a thin blue line above it.
| | 2.8 mm/3.3 mm PopLok™ Suture Anchors<br>Proposed | ConMed Linvatec Soft Tissue to Bone System<br>(including PopLok™ Suture Anchors)<br>Predicate |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components | PEEK anchor<br>Disposable Driver<br>Suture | PEEK anchor<br>Disposable Driver<br>Suture |
| Technological<br>Characteristics | 2.8 or 3.3 mm non-absorbable, PEEK anchor<br>Disposable driver<br>Threader<br>Supplied with one (1) #2 suture or two (#0) sutures packaged separately. | 3.5 or 4.5 mm non-absorbable, PEEK anchor<br>Disposable driver<br>Threader<br>Supplied with one (1) #2 suture packaged separately or without suture. |
## PERFORMANCE DATA
Testing has been completed to demonstrate that the 2.8 mm PopLok™ Suture Anchors perform as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
Verification Testing
- Reliability ●
- Ultimate Fixation Strength ●
- Cyclic ●
- Sterilization ●
- Pyrogen ●
- Biocompatibility
- Shelf-life ●
## VIII. CONCLUSION
The 2.8 mm/3.3 mm PopLok™ Suture Anchor PopLok™ Suture Anchor is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec Soft Tissue to Bone System. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the 2.8 mm/3.3 mm PopLok™ Suture Anchor is substantially equivalent to the ConMed Linvatec Soft Tissue to Bone System (K091549).
Validation Testing
- User Validation ●
- Packaging ●
- Transportation ●
