(128 days)
Not Found
No
The summary describes a mechanical suture anchor and its components, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is described as stabilizing damaged soft tissue in conjunction with postoperative immobilization throughout the healing period, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a surgical implant designed to reattach soft tissue to bone, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components made of PLA co-polymer, β-TCP, polyethylene, and polypropylene, along with a disposable driver for implantation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the ConMed Linvatec CrossFT™ BC Suture Anchor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "reattach[ing] soft tissue to bone in orthopedic surgical procedures." This is a surgical implant used directly on the patient's body during a procedure.
- Device Description: The description details a physical implantable device (anchor and sutures) and a tool for implantation (driver).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The provided information does not mention any such use or interaction with patient specimens.
The device is a surgical implant used for mechanical support and tissue repair within the body, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The ConMed Linvatec CrossFT™ BC 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, tendon, or joint capsules to the The suture anchor system thereby stabilizes the damaged soft tissue, in bone. conjunction with appropriate postoperative immobilization, throughout the healing period.
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The ConMed Linvatec CrossFT™ BC 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 PLA co-polymer + beta-TCP and two (2), or three (3) Hi-Fi® sutures manufactured of polyethylene and polypropylene. The device is bioabsorbable and is available in sizes between 4.5mm to 6.5mm diameter and 17mm lengths. A disposable driver is included to implant the suture anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The verification and validation testing of the ConMed Linvatec CrossFT™ BC Suture Anchor includes fixation strength, cyclic loading, insertion torque, material degradation and packaging/transportation qualification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K101100 p.1 of 2
AUG 2 6 2010
510(k) SUMMARY ConMed Linvatec CrossFT™ BC Suture Anchor
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 101100 .
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
John Cusack Regulatory Affairs Manager (727) 319-5562 Telephone (727) 399-5264 FAX
C. Device Name
| Trade Name: | ConMed Linvatec CrossFT™ BC Suture Anchor |
|---|---|
| Common Name: | Bioabsorbable suture anchor |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories. |
| Proposed Class/Device: | Class II |
| Product Code: | MAI |
| Regulation: | 21 CFR Part 888.3030 |
D. Predicate/Legally Marketed Devices
| Device Name: | ConMed Linvatec Soft Tissue to Bone System |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K091549 |
| Device Name: | ConMed Linvatec Bio Mini-Revo |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K053561 |
| Device Name: | ConMed Linvatec Matryx Interference Screw |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K052080 |
1
E. Device Description
The ConMed Linvatec CrossFT™ BC 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 PLA co-polymer + β-TCP and two (2), or three (3) Hi-Fi® sutures manufactured of polyethylene and polypropylene. The device is bioabsorbable and is available in sizes between 4.5mm to 6.5mm diameter and 17mm lengths. A disposable driver is included to implant the suture anchor.
F. Intended Use/ Indications
The ConMed Linvatec CrossFT™ BC 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.
G. Contraindications
The ConMed Linvatec CrossFT™ BC Suture Anchor is contraindicated for the following orthopedic procedures:
- ACL (Anterior Cruciate Ligament), PCL (Posterior Cruciate Ligament), foot, and hand procedures
H. Substantial Equivalence
The ConMed Linvatec CrossFT™ BC Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec CrossFT PEEK Suture Anchor (K091549 - Soft Tissue to Bone System), ConMed Linvatec Bio Mini-Revo Suture Anchor (K053561), and ConMed Linvatec Matryx Interference Screw (K052080). The verification and validation testing of the ConMed Linvatec CrossFT™ BC Suture Anchor includes fixation strength, cyclic loading, insertion torque, material degradation and packaging/transportation qualification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is positioned around the upper half of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
ConMed Linvatec c/o Mr. John Cusack Regulatory Affairs Manager 11311 Concept Boulevard Largo, Florida 33773
AUG 26 2010
Re: K101100
Trade/Device Name: CrossFT BC Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: MAI Dated: August 6, 2010 Received: August 9, 2010
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, 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 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
3
Page 2 - Mr. John Cusack
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.
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/CDRH/CDRHOffices/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.
Свойво Виенно
Mark N. Me kerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
ConMed Linvatec CrossFT™ BC Suture Anchor
Indications for Use:
The ConMed Linvatec CrossFT™ BC 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, tendon, or joint capsules to the The suture anchor system thereby stabilizes the damaged soft tissue, in bone. conjunction with appropriate postoperative immobilization, throughout the healing period.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shuta for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101100