(89 days)
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.
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, 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.
The provided text describes a 510(k) premarket notification for the "Arthrotek® LactoNail™" bioabsorbable bone fixation nail. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, and expert review is not present in the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate SmartPin™ (K925098) | "The testing demonstrates that the Arthrotek® LactoNail™ is substantially equivalent to the predicate." |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical or performance test set data is provided in the document. The testing was mechanical and comparative to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review was utilized for this type of test (mechanical equivalence).
4. Adjudication method for the test set: Not applicable. No adjudication method described as this relates to expert review, which was not performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about AI-assisted diagnosis or a multi-reader study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used:
For the mechanical testing, the "ground truth" was the mechanical performance of the predicate device, SmartPin™ (K925098). The new device's performance was compared against the known characteristics of the predicate to establish substantial equivalence.
8. The sample size for the training set: Not applicable. This is a medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable. (See point 8).
Summary of Study (Mechanical Testing):
The only "study" mentioned is non-clinical mechanical testing.
- Objective: To demonstrate that the Arthrotek® LactoNail™ is substantially equivalent in mechanical performance to the predicate device, SmartPin™ (K925098).
- Methodology: Mechanical testing was performed on the Arthrotek® LactoNail™ (specifically mentioning "600mg 100." - likely referring to a test condition or sample size, but not detailed). The results were then compared to the predicate device.
- Conclusion: The mechanical testing demonstrated substantial equivalence to the predicate device.
- Clinical Testing: "Clinical testing was not required for this product." This indicates that the regulatory pathway for this device, due to its similarity to an already marketed predicate, did not necessitate human clinical trials to prove safety and effectiveness. The substantial equivalence argument was based on material, function, labeling, sizing, and mechanical performance.
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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
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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)
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(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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§ 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.