(86 days)
Not Found
No
The summary describes a mechanical implant and surgical tools, with no mention of software, data processing, or AI/ML terms.
Yes
The device is described as an implant used in orthopedic surgical procedures to attach soft tissue to bone, which directly addresses a medical condition (tissue damage or detachment) and aims to restore function, meeting the definition of a therapeutic device.
No
The device description states its purpose is to "assist the surgeon in re-attaching soft tissue to bone via interference fixation." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states the system includes implants manufactured of PEEK material and a disposable driver, indicating physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ConMed Linvatec Intercept implants are physical implants used during surgery to attach soft tissue to bone. They are not used to analyze biological samples.
- Intended Use: The intended use clearly states "for attaching soft tissue to bone in orthopedic surgical procedures." This is a surgical intervention, not a diagnostic test.
The provided information describes a surgical implant and its use in a surgical procedure, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ConMed Linvatec Intercept implants are for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures: The Intercept implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The ConMed Linvatec Intercept Implant is a device that is used to assist the surgeon in re-attaching soft tissue to bone via interference fixation. The system includes implants, manufactured of PEEK (polyetheretherketone) material, in a range of sizes from 5mm to 8mm diameters and 12mm to 23mm lengths. A disposable driver is also part of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, orthopedic surgical procedures, arthroscopic or open surgical procedures
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)
Not Found
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
§ 888.3040 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.
0
: (1/2)
510(k) SUMMARY
DEC 2 3 2009
010
ConMed Linvatec Intercept Implant
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 K092998
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Dionne Sanders Regulatory Affairs Specialist (727) 319-5703 Telephone (727) 399-5264 FAX
C. Device Name
Trade Name: Common Name: Classification Name: Proposed Class/Device: Product Code: Regulation:
ConMed Linvatec Intercept Implant
Nonabsorbable suture anchor system Fastener, fixation, nondegradable, soft tissue Class II MBI 21 CFR Part 888.3040
D. Predicate/Legally Marketed Devices
| Device Name: | Matryx® Interference Screw |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K063588 |
Device Name: Company Name: 510(k) #:
Arthrex Interference Screw Arthrex, Inc. K062466
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E. Device Description
The ConMed Linvatec Intercept Implant is a device that is used to assist the surgeon in re-attaching soft tissue to bone via interference fixation. The system includes implants, manufactured of PEEK (polyetheretherketone) material, in a range of sizes from 5mm to 8mm diameters and 12mm to 23mm lengths. A disposable driver is also part of the system.
F. Intended Use/ Indications
The ConMed Linvatec Intercept Implant is for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures. The Intercept Implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.
G. Substantial Equivalence
The ConMed Linvatec Intercept Implant is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Matryx Interference Screw (K063588) and the Arthrex Interference PEEK Screw (K062466) predicate devices.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a bird-like figure with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Linvatec Corporation % Ms. Dionne Sanders Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
DEC 2 3 2009
Re: K092998
Trade/Device Name: ConMed Linvatec Intercept Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 9, 2009 Received: December 10, 2009
Dear Ms. Sanders:
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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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/CDRHQffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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): K092998
Device Name: ConMed Linvatec Intercept Implant
Indications for Use:
The ConMed Linvatec Intercept implants are for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures: The Intercept implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.
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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number _/i092958