(260 days)
Not Found
No
The description focuses on the material composition and mechanical properties of a resorbable bone screw for ACL reconstruction, with no mention of AI or ML.
Yes
The device is used for anterior cruciate ligament reconstruction, which is a therapeutic intervention to repair damaged ligaments.
No
The device, LIGAFIX®, is described as a resorbable interference bone screw used for fixation of grafts in anterior cruciate ligament reconstruction. Its function is to secure grafts, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly states that LIGAFIX® is a physical, resorbable bone screw made of a mixture of tri calcium phosphate and Poly Lactic Acid. It is a hardware device used for surgical fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- LIGAFIX® Function: LIGAFIX® is a surgical implant used to physically fix a graft during anterior cruciate ligament reconstruction. It is a mechanical device that provides structural support within the body.
- Lack of Diagnostic Testing: The description of LIGAFIX® does not mention any testing of biological samples or the provision of diagnostic information. Its purpose is purely mechanical fixation.
Therefore, based on the provided information, LIGAFIX® clearly falls outside the definition and function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LIGAFIX® is indicated for use in anterior cruciate ligament reconstruction to provide interference fixation of grafts.
LIGAFIX® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (β-TCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
LIGAFIX® is a resorbable cannulated screw designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX® interference bone screw is made of a 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA)(6v composite. LIGAFIX® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches. LIGAFIX® screws present a socket which accepts a screwdriver of triangular cross-section that inserts deep into the core of the screw, to produce improved torque distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cruciate ligament
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)
Biological, mechanical and biocompatibility tests have been performed. Results confirmed that LIGAFIX® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft. LIGAFIX® screws strength retention profiles are compatible with the healing process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510(k) Premarket Notification K050407 LIGAFIX® Interference screw
Image /page/0/Picture/1 description: The image contains the words "SCIENCE FOR Bio MATERIALS" in a stylized font. There are three black triangles pointing to the right. In the upper right corner, there is some handwritten text that appears to be a code or reference number, possibly "K050467" followed by "page".
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. GENERAL INFORMATION | |
|---|---|
| Trade Name | LIGAFIX® 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 marketed predicate devices | BioLok® Screw K002070 (Biocomposites Ltd) |
| BIOSORB® Resorbable Void Filler K021963 (SBM) | |
| Submitter | SCIENCE FOR BIOMATERIALS |
| Sciences et Bio Matériaux | |
| ZI du Monge | |
| F 65100 LOURDES - FRANCE | |
| Owner operation Number : 9063735 | |
| Contact | Denis CLEMENT, General Manager |
| Tel : +33 (0)5 62 42 21 01 | |
| Fax : +33 (0)5 62 42 21 00 | |
| e-mail : denis.clement.sr@wanadoo.fr | |
| Regulatory contact: Idée Consulting (FRANCE) | |
| Isabelle DRUBAIX e-mail : idrubaix@nordnet.fr |
NOV - 4 2005
2. DEVICE DESCRIPTION
LIGAFIX® is a resorbable cannulated screw designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX® interference bone screw is made of a 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA)(6v composite. LIGAFIX® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches. LIGAFIX® screws present a socket which accepts a screwdriver of triangular cross-section that inserts deep into the core of the screw, to produce improved torque distribution.
3. INTENDED USE
LIGAFIX® is indicated for use in anterior cruciate ligament reconstruction to provide interference fixation of grafts.
4. PERFORMANCE DATA
Biological, mechanical and biocompatibility tests have been performed. Results confirmed that LIGAFIX® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft. LIGAFIX® screws strength retention profiles are compatible with the healing process.
5. SUBSTANTIAL EQUIVALENCE
LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of intended use, material, design and function.
Revised version: October 13, 2005
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Public Health Service
NOV - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Denis Clement General Manager Sciences et BioMatériaux ZI du Monge F 65100 Lourdes FRANCE
Re: K050407
Trade/Device Name: LigaFix® Resorbable Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 17, 2005 Received: October 24, 2005
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, listing 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
2
Page 2 - Mr. Denis Clement
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. 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 yours,
Mark N. Melkerson
der Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/1 description: The image shows the words "Science for Biomaterials" in a stylized font. The word "Science" is in a smaller font than the rest of the words. The word "Bio" is subscripted. There are three black triangles pointing to the right after the words.
510(k) Number (if known): K050407
Device Name: LIGAFIX® RESORBABLE INTERFERENCE SCREW
Indications for Use:
LIGAFIX® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (β-ΤCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No
(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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | 0 0 0 0 4 |
| 510(k) Number | K050407 |
| Page 1 of 1 |