(69 days)
Not Found
No
The summary describes a resorbable bone screw for ACL reconstruction, focusing on material composition, dimensions, and mechanical properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is designed for the interference fixation of grafts in anterior cruciate ligament reconstruction, which is a therapeutic intervention.
No
The device description indicates that it is a resorbable interference bone screw used for the fixation of grafts in anterior cruciate ligament reconstruction, which is a therapeutic function, not a diagnostic one.
No
The device is a physical bone screw made of a composite material, not software. The description details its composition, dimensions, and intended use as a physical implant for surgical fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text clearly describes a surgical implant (a bone screw) used to fix grafts during anterior cruciate ligament reconstruction. It is physically implanted into the body.
- Intended Use: The intended use is for the "interference fixation of grafts in anterior cruciate ligament reconstruction," which is a surgical procedure performed directly on the patient's body.
The device is a resorbable bone screw, which falls under the category of surgical devices or implants, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MAI
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.
The purpose of this 510(k) was to address modifications to the head of certain screw configurations, along with modifications to the cannula to allow use with 1.1mm guide wire. The subject system offers screws in diameters ranging from 7 mm to 12 mm with lengths ranging from 20 mm to 35 mm.
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)
Mechanical tests and dimensional analysis confirmed that LIGAFIX / ComposiTCP screws are biocompatible and presents the requisite strength to provide sustained fixation of the graft.
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.
K050407, K061262, K070507, K090994
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510 (k) LIGAFIX Interference Screw
OCT 2012
510(k) SUMMARY
As required by section 807.92
| Submitter | SCIENCE FOR BIOMATERIALS |
|---|---|
| Sciences et Bio Matériaux | |
| ZI du Monge | |
| F 65100 LOURDES - FRANCE | |
| Registration Number : 3004549189 | |
| Contacts | Denis CLEMENT, CEO |
| Tel : +33 (0)5 62 42 21 01 | |
| Fax : +33 (0)5 62 42 21 00 | |
| e-mail : denis.clement@sbm-fr.com | |
| Regulatory contact: anne.cospin@sbm-fr.com | |
| Trade Name | LIGAFIX® Resorbable Interference Screw |
| ComposiTCP® Resorbable Interference Screw | |
| 510k | SPECIAL 510K |
| CFR section | 21CFR 888.3030 |
| Classification Name | Fastener, fixation, biodegradable, soft tissue |
| Class | II |
| Product Codes | MAI |
| Device panel | ORTHOPEDIC |
| Legally marketed | |
| predicate devices | LIGAFIX* INTERFERENCE SCREW (K050407, K061262, K070507 and |
| K090994) manufactured by SCIENCE FOR BIOMATERIALS |
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.
The purpose of this 510(k) was to address modifications to the head of certain screw configurations, along with modifications to the cannula to allow use with 1.1mm guide wire. The subject system offers screws in diameters ranging from 7 mm to 12 mm with lengths ranging from 20 mm to 35 mm.
1
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.
Performance data Mechanical tests and dimensional analysis confirmed that LIGAFIX / ComposiTCP screws are biocompatible and presents the requisite strength to provide sustained fixation of the graft.
Substantial equivalence The modifications to LIGAFIX / ComposiTCP Interference screw (K050407, K061262, K070507 and K090994) consist of additional references of screw together with the modification of existing references.
The additional LIGAFIX / ComposiTCP Interference screws are substantially equivalent to their predicate devices LIGAFIX / ComposiTCP Interference screw (K050407, K061262, K070507 and K090994) in terms of intended use, material, design, mechanical properties and function.
Preparation date, October 3, 2012.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 3 2012
SBM Sciences for Bio Materials % Mr. Denis Clement ZI du Monge LOURDES 65100 France
Re: K12228
Trade/Device Name: LIGAFIX Resorbable Interference Screw, ComposiTCP Resorbable Interference Screw
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: MAI Dated: September 3, 2012 Received: September 5, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Denis Clement
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) LIGAFIX Interference Screw
INDICATIONS FOR USE
510(k) Number (if known): K122228
LIGAFIX® RESORBABLE INTERFERENCE SCREW Device Name: ComposiTCP® RESORBABLE INTERFERENCE SCREW
Indications for 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.
Prescription Use Over-The-Counter Use . >| AND/OR (Part 21 CFR 801 Subpart D) (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)
A
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122288
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