(27 days)
Not Found
No
The 510(k) summary describes a mechanical surgical system for reattaching soft tissue to bone, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
Explanation: The device is intended to reattach soft tissue to bone in orthopedic surgical procedures to stabilize damaged soft tissue throughout the healing period, which is a therapeutic purpose.
No
Explanation: The device is a surgical system intended to reattach soft tissue to bone, serving a therapeutic purpose rather than diagnosing diseases or conditions.
No
The device description explicitly details physical components like anchors, bone taps, bone punches, drivers, and a suture passer, indicating it is a hardware-based medical device system.
Based on the provided information, this device 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 procedure performed directly on the patient's body.
- Device Description: The description details surgical implants (anchors) and instruments used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
Therefore, the ConMed Linvatec Soft Tissue to Bone System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The ConMed Linvatec Soft Tissue to Bone System 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The ConMed Linvatec Soft Tissue to Bone System includes anchors in a range of sizes and materials from 3.5 mm to 6.5 mm diameter and 15 mm to a 17 mm length with one (1) to three (3) non-absorbable suture configurations. The anchor sizes correspond to a series of general surgical instruments such as; bone taps, bone punches, drivers, and a suture passer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft tissue (ligaments, tendons, or joint capsules)
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)
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.
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510(k) SUMMARY ConMed Linvatec Soft Tissue to Bone System
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 K091549.
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
JUN 23 2009
B. Company Contact
John Cusack Regulatory Affairs Specialist (727) 399-5562 Telephone FAX (727) 399-5264
C. Device Name
Trade Name: Common Name: Classification Name: Proposed Class/Device: Product Code: Regulation:
ConMed Linvatec Soft Tissue to Bone System Nonabsorbable suture anchor system Fastener, Fixation, Nondegradable, Soft tissue Class II MBI 21 CFR Part 888.3040
D. Predicate/Legally Marketed Devices
| Device Name: | LM Bone Anchor (renamed ConMed Linvatec Ultrafix RC®) |
|---|---|
| Company Name: | Li Medical Technologies Inc (purchased by ConMed Linvatec) |
| 510(k) #: | K963812 |
| Device Name: | ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K073481 |
| Device Name: | ConMed Linvatec Bio Mini-Revo® |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K053561 |
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E. Device Description
The ConMed Linvatec Soft Tissue to Bone System includes anchors in a range of sizes and materials from 3.5 mm to 6.5 mm diameter and 15 mm to a 17 mm length with one (1) to three (3) non-absorbable suture configurations. The anchor sizes correspond to a series of general surgical instruments such as; bone taps, bone punches, drivers, and a suture passer.
F. Intended Use/ Indications
The ConMed Linvatec Soft Tissue to Bone System 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. Substantial Equivalence
The ConMed Linvatec Soft Tissue to Bone System is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 23 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Linvatec Corporation c/o Mr. John Cusack 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K091549
Trade/Device Name: ConMed Linvatec Soft Tissue to Bone System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 26, 2009 Received: May 27, 2009
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. Ilsting 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 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Cusack
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchup
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):
Device Name: ConMed Linvatec Soft Tissue to Bone System
Indications for Use:
The ConMed Linvatec Soft Tissue to Bone System 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.
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)
Barbara Buehrig
Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091549