(89 days)
Not Found
No
The summary describes a bioabsorbable bone fixation nail made of a specific copolymer, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is used for fixation of bone fragments and alignment of fractures, which are structural repairs rather than therapeutic treatments of disease.
No
The device is a bone fixation nail used to fix fractured bones, osteotomies, and arthrodesis, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "bioabsorbable bone fixation nail" constructed of a resorbable copolymer, indicating it is a physical implantable device, not software.
Based on the provided information, the Arthrotek® LactoNail™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fixation of bone fragments during surgery. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is a bioabsorbable bone fixation nail made of a copolymer. This is a physical device implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health or condition. The Arthrotek® LactoNail™ does not perform any such diagnostic testing on specimens.
Therefore, the Arthrotek® LactoNail™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrotek® LactoNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. Indications for use include the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
Product codes
HTY
Device Description
The Arthrotek® LactoNail™ bioabsorbable bone fixation nail is constructed of a resorbable copolymer composed of PLLA/ PGA. The device is available in 1.6, 2.0, and 2.6mm diameters. The LactoNail™ comes in four (4) lengths (14, 18, 22, and 26mm). Arthrotek® LactoNail™ maintains alignment of small bone fractures and apical fragments, osteochondral fragments and cancellous/non-load bearing fragments following arthroscopy or open surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-load bearing bones
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)
Non-Clinical Testing: Mechanical testing was performed on the Arthrotek® LactoNail™. The testing demonstrates that the Arthrotek® LactoNail™ is substantially equivalent to the predicate.
Clinical Testing: Clinical testing was not required for this product.
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
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
MAY 2 5 2004
K040500
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Image /page/0/Picture/2 description: The image shows the logo for ARTHROTEK, a Biomet Company. The logo is in black and white, with the word "ARTHROTEK" in large, bold letters. The "O" in ARTHROTEK is replaced by a solid black circle. Below the company name, in smaller letters, it says "A BIOMET COMPANY".
CORPORATE HEADQUARTERS
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Tracy J. Bickel, RAC Contact Person: Regulatory Associate
Proprietary Name: Arthrotek® LactoNail™
Common Name: resorbable bone fixation nail
Classification Code: HTY
Classification Name: Pin, Fixation, Smooth (888.3040)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: SmartPin™ (Bionx Implants) - K925098
Device Description: The Arthrotek® LactoNail™ bioabsorbable bone fixation nail is Device Deseription. The Archives
constructed of a resorbable copolymer composed of PLLA/ PGA. The device is available in 1.6, 2.0, and 2.6mm diameters. The LactoNail™ comes in four (4) lengths (14, 18, 110/ 210/ 210/ and 26mm). Arthrotek® LactoNail™ maintains alignment of small bone fractures and apical fragments, osteochondral fragments and cancellous/non-load bearing fragments following arthroscopy or open surgery.
Indications for Use: The Arthrotek® LactoNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. fragments of nuctured non load beaning of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
Summary of Technologies: The Arthrotek® LactoNail™ is similar to or identical in terms of material, function, labeling, and sizing to the predicate SmartPin™ (K925098).
Non-Clinical Testing: Mechanical testing was performed on the Arthrotek® LactoNail™ ron Cirment Testing Preshiban (600mg 100.). The testing demonstrates that the Arthrotek® LactoNail™ is substantially equivalent to the predicate.
Clinical Testing: Clinical testing was not required for this product.
All trademarks are property of Arthrotek, Inc. unless otherwise noted SmartPin is a trademark of Bionx Implants Inc. 56 E. Bell Drive
()FFICE 219 267 6639
F-MAIL arthrotek&geurthrotek.com
દપ્પ
Warsaw, IN 46582
PAX 219.372.1718
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Ms. Tracy J. Bickel, RAC Regulatory Associate Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581
Re: K040500
Trade/Devicc Name: Arthrotek® LactoNail™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: February 25, 2004 Received: February 27, 2004
Dear Ms. Bickel:
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 (sec 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 I'DA'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.
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Page 2 - Ms. Tracy J. Bickel, RAC
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 (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely vours,
Sincerely yours,
Mark N Mllhurn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Ko40500 510(k) Number (if known):
Device Name: Artrhotek® LactoNail™
Indications For Use:
The Arthrotek® LactoNail™ is intended for use in the fixation of fragments of fractured The Arthrotek® Lactoriali - Is intended for ass in assommes include the fixation of non-load bearing bones, osteocomics, and arthrousser assistential.
apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
$\mu_o$
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mulkerron
Division of General, Restorative, and Neurological Devices
510(k) Number K040500
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