(74 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and its materials, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used to reattach soft tissue to the bone and stabilize it during healing, which directly contributes to the restoration of normal function and health of the tissue.
No
The provided text describes a medical device used to reattach soft tissue to bone after surgical procedures. Its purpose is to stabilize damaged soft tissue during healing, not to diagnose a condition or disease.
No
The device description clearly describes a physical, bioabsorbable suture anchor made of PLA copolymer, preloaded on a disposable inserter, and includes nonabsorbable sutures. This is a hardware medical device.
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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a suture anchor used in surgical procedures to reattach soft tissue to bone. It is a physical implant used within the body during surgery.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens or providing diagnostic information based on such analysis.
The device described is a surgical implant used for mechanical stabilization, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device 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
MAI
Device Description
The ConMed Linvatec Paladin Suture Anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with two nonabsorbable, braided, polyethylene sutures. The ConMed Linvatec Paladin Suture Anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The copolymer is inert and non-collagenous through the absorption process. The device will be available in 5.0mm - 6.5mm in size with colorant D&C violet #2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft tissue, such as 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)
Reference Device(s)
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
(pg. 1 of 2)
APR 1 0 2009
510(k) SUMMARY
ConMed Linvatec Paladin™, Preloaded with two #2 Hi-Fi® Sutures
In accordance with the requirements of the Safe Medical Device Act of 1990 and in accerdance that thereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number K090186.
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Joy Lovett Regulatory Affairs Specialist (727) 399-5137 Telephone (727) 399-5264 FAX
C. Device Name
| Trade Name: | ConMed Linvatec Paladin, Preloaded with two
#2 Hi-Fi® Sutures |
|------------------------|------------------------------------------------------------------|
| Common Name: | Bioabsorbable suture anchor |
| Classification Name: | Biodegradable soft tissue fixation fastener |
| Proposed Class/Device: | Class II |
| Product Code: | MAI |
| Regulation: | 21 CFR Part 888.3030 |
D. Predicate/Legally Marketed Devices
| Device Name: | ConMed Linvatec Duet Suture Anchor |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K042966 |
| Device Name: | ConMed Linvatec Bio Mini-Revo Suture Anchor |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K053561 |
1
K090186 (pg. 2 of 2)
E. Device Description
The ConMed Linvatec Paladin Suture Anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with two nonabsorbable, braided, polyethylene sutures. The ConMed Linvatec Paladin Suture Anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The copolymer is inert and non-collagenous through the absorption process. The device will be available in 5.0mm - 6.5mm in size with colorant D&C violet #2.
F. Intended Use/ Indications
The device 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 Paladin Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices K042966 and K053561.
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 stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2009
ConMed Livatec % Ms. Joy Lovett Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K090186
Trade/Device Name: ConMed Linvatec Paladin, Preloaded with tow #2 Hi-Fi Sutures Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI Dated: March 12, 2009
Received: March 13, 2009
Dear Ms. Lovett:
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.
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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
for
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K090186 510(k) Number (if known): __
ConMed Linvatec Paladin, Preloaded with two #2 Hi-Fi Sutures Device Name:
Indications for Use:
The device 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 (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Claula Bussell for mkm
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K091086