(20 days)
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is an implant used for reattaching soft tissue to bone, which is a structural or supportive function, not a therapeutic one that actively heals or treats a disease through direct biological or physiological action.
No
This device is a surgical implant (suture anchor) used for reattaching soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly states it is a "sterile, single-use, metal implant" and is "manufactured from 316LS Stainless Steel," indicating it is a physical hardware device, not software only.
Based on the provided information, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Conmed Linvatec Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is described as a "sterile, single-use, metal implant that is preloaded with high strength size 2 non-absorbable braided polyethylene suture."
- Intended Use: Its intended use is "for reattaching soft tissue to glenoid bone in the shoulder."
This device is an implantable surgical device used directly within the body for structural repair, not for analyzing biological specimens outside the body.
N/A
Intended Use / Indications for Use
The Conmed Linvatec Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lessons, SLAP lesions, capsular shifts, capsulolabral reconstructions.
Product codes
MBI, HWC
Device Description
The Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is a sterile, single-use, metal implant that is preloaded with high strength size 2 non-absorbable braided polyethylene suture.
The implanted anchor is manufactured from 316LS Stainless Steel, per ASTMF-138, ISO 832-1 and is preloaded with a non-absorbable, braided, ultra-high molecular weight, polyethylene suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenoid bone in the shoulder
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
§ 888.3040 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
Ko60714 Pge 1/2
6 2006 APR
March 1, 2006
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMedLinvatec is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the Hi-Fi UltraFix Knotless Minimite Suture Anchor.
Submitter A.
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264FAX
C. Device Name
| Trade Name: | Hi-Fi UltraFix Knotless Minimite Suture Anchor |
|---|---|
| Common Name: | Soft tissue fixation suture anchor |
| Classification Names: | 888.3040 - Fastener, Fixation, Nondegradable, Soft |
| Tissue | |
| Proposed Class/Device: | Class II |
| Product Code: | MBI |
Predicate/Legally Marketed Devices D.
K022827 -- Ultrafix Knotless Minimite Suture Anchor
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Page 242
Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor Special 510(k) # _____________________________________________________________________________________________________________________________________________________________ March 1, 2006
E. Device Description
The Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is a sterile, single-use, metal implant that is preloaded with high strength size 2 non-absorbable braided polyethylene suture.
The implanted anchor is manufactured from 316LS Stainless Steel, per ASTMF-138, ISO 832-1 and is preloaded with a non-absorbable, braided, ultra-high molecular weight, polyethylene suture.
Intended Use
The Conmed Linvatec Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lessons, SLAP lesions, capsular shifts, capsulolabral reconstructions.
F. Substantial Equivalence
Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is substantially equivalent in indication for use, scientific technology and design to the UltraFix@ Knotless Minimite® Suture Anchor. The UltraFix® Knotless Minimite® Suture Anchor was cleared by FDA under 510(k) K022827. The changes made to the predicate device have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2006 APR
ComMed Linvatec c/o Ms. Elizabeth Paul Manager, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K060714
Trade/Device Name: Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: March 1, 2006 Received: March 17, 2006
Dear Ms. Paul:
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. Iisting 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); 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.
3
Page 2 - Ms. Elizabeth Paul
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
J. Vicker Lemon (3)
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Ko 60714
Device Name: Hi-Fi™ UltraFix® Knotless Mirrimite® Suture Anchor
Indications for Use:
The Conmed Linvatec Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lesions, SLAP lesions, capsular shifts, capsulolabral reconstructions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUF: ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Levice Evaluation (ODE)
OR Prescription Use __X (Per 21 CFR 801.109)
Over-the-Counter Use _No
Hulur Semedix
Division of General, Restorates and Neurological Devices
510(k) Number k0160714