(29 days)
LIGAFIX® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
LIGAFIX® / ComposiTCP® range of products consists of resorbable cannulated screws available in several models designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
LIGAFIX® / ComposiTCP® interference bone screw is made of a ceramic (beta-TCP) / polymer (Poly Lactic Acid -PLA) composite.
LIGAFIX® / ComposiTCP® interference screw is available in several sizes and in two beta-TCP/ PLA ratios 60/40 (LIGAFIX® 60/ ComposiTCP® 60) and 30/70 (LIGAFIX® 30/ ComposiTCP® 30)
LIGAFIX® / ComposiTCP® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches.
The provided text describes a 510(k) premarket notification for the LIGAFIX® / ComposiTCP® Resorbable Interference Screw. This document is a regulatory submission for a medical device seeking substantial equivalence to existing devices, not a study report proving the device meets an acceptance criterion with detailed findings. Therefore, much of the requested information regarding specific acceptance criteria and detailed study parameters for performance is not present in the provided text.
However, based on the information available, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document states: "Biological, mechanical and biocompatibility tests confirmed that LIGAFIX® / ComposiTCP® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft. LIGAFIX®/ ComposiTCP® screws strength retention profiles are compatible with the healing process."
This is a high-level summary of the reported performance, but specific quantitative acceptance criteria (e.g., "tensile strength must be >X MPa") and corresponding reported numerical performance values are not detailed in the provided text.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility | "highly biocompatible" |
| Requisite strength for sustained graft fixation | "presents the requisite strength to provide sustained fixation of the graft" |
| Strength retention profile compatibility with healing process | "strength retention profiles are compatible with the healing process" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text mentions "Biological, mechanical and biocompatibility tests" but does not detail the methodology, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature) of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as the document describes a regulatory submission for a physical medical device (interference screw) and not an AI/diagnostic software. "Ground truth" in the context of expert review for diagnostic accuracy is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above.
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:
This information is not applicable as the device is an interference screw, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable for the reasons stated above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable as the document pertains to a physical medical device. The "truth" for the performance claims would be established through laboratory testing (mechanical, biological) rather than expert review of images or pathology.
8. The sample size for the training set:
This information is not applicable as the document is for a physical medical device and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image shows the text "SPECIAL 510k" on the first line and "LIGAFIX® Interference screws" on the second line. The text is in a bold, sans-serif font. The word "SPECIAL" is in all caps, and the number "510k" is next to it. The word "LIGAFIX" is followed by the registered trademark symbol. The words "Interference screws" are below the word "LIGAFIX".
Image /page/0/Picture/1 description: The image shows the words "Science for Bio Materials" in a stylized font. The word "Bio" is subscripted. Underneath the words is a smaller line of text that is difficult to read. To the right of the words are three triangles pointing to the right, with each triangle having a different shade of gray.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. GENERAL INFORMATION
| Trade Name | LIGAFIX® Resorbable Interference ScrewComposiTCP® Resorbable Interference Screw |
|---|---|
| Common Name | Bone Fixation Screw |
| Classification Name | Screw, Fixation, Bone |
| Class | II |
| Product Code | HWC |
| CFR section | 21CFR 888.3040 |
| Device panel | Orthopedic |
| Legally marketedpredicate devices | LIGAFIX® INTERFERENCE SCREW (K061262 andK070507) manufactured by SCIENCE FORBIOMATERIALS |
| Submitter | SCIENCE FOR BIOMATERIALSSciences et Bio MatériauxZI du MongeF 65100 LOURDES - FRANCERegistration Number : 3004549189 |
| Contact | Denis CLEMENT, CEOTel : +33 (0)5 62 42 21 01Fax : +33 (0)5 62 42 21 00e-mail : denis.clement@sbm-fr.comRegulatory contact: Idée Consulting (FRANCE)Isabelle DRUBAIX e-mail : idrubaix@nordnet.fr |
2009
2. DEVICE DESCRIPTION
LIGAFIX® / ComposiTCP® range of products consists of resorbable cannulated screws available in several models designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
LIGAFIX® / ComposiTCP® interference bone screw is made of a ceramic (beta-TCP) / polymer (Poly Lactic Acid -PLA) composite.
LIGAFIX® / ComposiTCP® interference screw is available in several sizes and in two beta-TCP/ PLA ratios 60/40 (LIGAFIX® 60/ ComposiTCP® 60) and 30/70 (LIGAFIX® 30/ ComposiTCP® 30)
LIGAFIX® / ComposiTCP® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches.
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SPECIAL 510k
LIGAFIX® Interference screws
SCIENCE FOR BIO MATERIALS
K090994
(page 2 of 2)
3. INTENDED USE
LIGAFIX® / ComposiTCP® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (beta-TCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
4. PERFORMANCE DATA
Biological, mechanical and biocompatibility tests confirmed that LIGAFIX® / ComposiTCP® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft. LIGAFIX®/ ComposiTCP® screws strength retention profiles are compatible with the healing process.
5, SUBSTANTIAL EQUIVALENCE
The modifications to LIGAFIX® / ComposiTCP® Interference screw (K050407, K061262 and K070507) consist of additional size of screw together with the deletion of a reference to surgical technique in the instructions for use.
The additional LIGAFIX® / ComposiTCP® Interference screws are substantially equivalent to their predicate devices LIGAFIX® / ComposiTCP® Interference screw (K050407, K061262 and K070507) in terms of intended use, material, design, mechanical properties and function.
Summary preparation date:
May 5, 2009
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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 or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SCIENCE FOR BIOMATERIALS % Mr. Denis Clement CEO ZI du Monge F 65100 LOURDES - FRANCE
Re: K090994
Trade/Device Name: LIGAFIX® RESORBABLE INTEREFERNCE SCREW ComposiTCP® RESORBABLE INTERFERENCE SCREW Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 23, 2009 Received: April 7, 2009
Dear Mr. Clement :
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 (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- Mr. Denis Clement
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,
Daniel Keane
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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LIGAFIX® Interference screws
SCIENCE FOR BioMATERIALS
K090994 510(k) Number (if known):
LIGAFIX® RESORBABLE INTERFERENCE SCREW Device Name: ComposiTCP® RESORBABLE INTERFERENCE SCREW
Indications for Use:
"LIGAFIX® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction."
) Prescription Use 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 of NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Surgical, Orthopedic,
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510(k) Number K090994
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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.