(55 days)
The GENESYS PressFT 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 bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.
The ConMed Linvatec GENESYS PressFT™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of 96L/4D copolymer + B-TCP and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is bioabsorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor. The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. 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. Additional surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.
This document describes the premarket notification (510(k)) for the ConMed Linvatec GENESYS PressFT™ Suture Anchor. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to independently prove specific performance against a predefined acceptance criterion study in the same way a PMA or a de novo submission might.
Therefore, the information presented is focused on demonstrating the GENESYS PressFT™ Suture Anchor's equivalence to existing devices through various types of testing, rather than a standalone clinical study against specific acceptance criteria for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of "acceptance criteria" against which a clinical performance study was conducted. Instead, it describes a series of engineering and biocompatibility tests conducted to demonstrate the safety and effectiveness of the device and its substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests.
| Test Type | Acceptance Criteria (Implied by equivalence) | Reported Device Performance (Implied) |
|---|---|---|
| Fixation Strength | Comparable to predicate devices | Passed |
| Cyclic Loading | Comparable to predicate devices | Passed |
| Insertion | Functionally effective | Passed |
| Driver Strength | Functionally effective | Passed |
| Biocompatibility | Meets ISO 10993 standards | Passed |
| Sterilization | Validated | Passed |
| Shelf-Life | Validated | Passed |
| Packaging Qualifications | Validated for integrity and sterility | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for the individual engineering, biocompatibility, sterilization, shelf-life, or packaging tests.
- Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for engineering and biocompatibility evaluations. These are typically benchtop or in-vitro tests, not human clinical trials.
- Data Provenance: The data is generated from laboratory testing conducted by the manufacturer, ConMed Linvatec. This is assumed to be prospective for the purpose of this submission, though it's in vitro or ex vivo testing, not human-patient data. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (likely in the US given the submission to the FDA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert readers or ground truth establishment in the clinical diagnostic sense. The "ground truth" for these tests would be the specific pass/fail criteria for each engineering or biocompatibility test, typically defined by engineering standards, regulatory guidelines (e.g., ISO for biocompatibility), or internal company specifications derived from predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is not a study involving interpretations by multiple experts. The "adjudication" is essentially the comparison of test results against predetermined engineering, biological, and functional specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device for orthopedic surgery (suture anchor), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (suture anchor), not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for the "testing" section is based on:
- Engineering Standards: For fixation strength, cyclic loading, insertion, and driver strength, the "ground truth" refers to the mechanical and performance specifications derived from regulatory requirements, industry standards, and the performance characteristics of the predicate devices.
- Biocompatibility Standards: For biocompatibility, the "ground truth" conforms to recognized international standards (e.g., ISO 10993 series).
- Sterilization and Packaging Standards: For sterilization and packaging, the "ground truth" refers to validated processes and industry/regulatory standards for ensuring product sterility and integrity.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI algorithms, thus there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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K121990
5. 510(k) Summary
AUG 22 2012
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 510(k) Number
Date Prepared: June 26, 2012
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Lorna K. Linville Director, Requlatory Affairs Telephone: (727) 399-5396 Fax (727) 399-5264
C. Device Name
| Trade Name: | GENESYS PressFT ™ Suture Anchor |
|---|---|
| Common Name: | Bioabsorbable Suture Anchor |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft tissue |
| Proposed Class/Device: | Class II |
| Product Code: | MAI |
| Regulation: | 21 CFR Part 888.3030 |
D. Predicate/Legally Marketed Devices
| Device Name: | ConMed Linvatec NANOTM Suture Anchor |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K112965 |
ConMed Linvatec CrossFT™-BC Suture Anchor Device Name: Company Name: ConMed Linvatec K101100 510(k) #:
E. Device Description
The ConMed Linvatec GENESYS PressFT™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of 96L/4D copolymer + B-TCP and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is bioabsorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is
Page 1 of 2
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K121890
utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor.
The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. 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. Additional surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.
F. Testing
The verification and validation testing of the GENESYS PressFT™ Suture Anchor includes fixation strength, cyclic loading, insertion, driver strength, biocompatibility, sterilization, shelf-life, and packaging qualifications.
G. Intended Use / Indications
The GENESYS PressFT™ 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 bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.
H. Conclusion
The GENESYS PressFT™ Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec NANO™ Suture Anchor (K112965) and the ConMed Linvatec CrossFT™-BC Suture Anchor (K101100).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConMed Linvatec % Ms. Lorna K. Linville Director, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908
AUG 22222012
Re: K121890
Trade/Device Name: Genesys PressFT Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories.
Class II
Regulatory Class: Class II Product Code: MAI Dated: July 27, 2012 Received: July 30, 2012
Dear Ms. Linville:
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. 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 (reporting of medical
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Page 2 - Ms. Lorna K. Linville
device-related adverse events) (21 CFR 803); 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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
,
le
erson
Mark N. Melkerson Director Division of Surgical, Orthopedic & 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): ≤ / 2 /8 9 6
GENESYS PressFT Suture Anchor Device Name:
Indications for Use:
The GENESYS PressFT 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 bone. The suture anchor system thereby stabilizes the damaged soft tissue in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Arst
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121890
01:
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.