(36 days)
Not Found
No
The device description focuses solely on the material composition, design variations, and physical characteristics of a surgical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
A therapeutic device intends to treat or alleviate a disease or condition. The LIGAFIX® interference screws are designed for the "interference fixation of grafts in anterior cruciate ligament reconstruction," which is a treatment for a damaged ACL.
No
Explanation: The device is an interference screw used for securing grafts during anterior cruciate ligament reconstruction. Its purpose is mechanical fixation, not diagnosis.
No
The device description clearly states that the device is a physical, resorbable cannulated screw made of ceramic and polymer composite, intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "interference fixation of grafts in anterior cruciate ligament reconstruction." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical screw designed to be implanted into the body.
- Anatomical Site: The device is used in the "anterior cruciate ligament," which is an anatomical structure within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such testing.
The device is a surgical implant used for structural support during a reconstructive procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
"LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruclate ligament reconstruction."
Product codes
HWC
Device Description
LIGAFIX® are resorbable cannulated screws made of ceramic (β-ΤCP) / polymer (Poly Lactic Acid) composite and designed for the interference fixation of grafts in anterlor cruciate ligament reconstruction.
To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise:
- 2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA)
- 3 head design: standard reduced -- rounded
- Diameters from 7 mm to 11 mm
- Lengths from 20 mm to 35 mm
LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.
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
Not Found
Key Metrics
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
Ko7o5o7
SPECIAL 510k
LIGAFIX® Interference screws
Image /page/0/Picture/3 description: The image shows the words "Science for Bio Materials" in a stylized font. The word "Science" is in a smaller font than the words "Bio Materials". There are three right-pointing triangles to the right of the words. The words "Science for Bio Materials" are underlined.
MAR 2 9 2007 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 | LIGAFIX® Resorbable Interference Screw K050407 and K061262 |
| Reason for special 510k | Extension of the range of products |
| 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@sbm-fr.com | |
| Regulatory contact: Idée Consulting (FRANCE) | |
| Isabelle DRUBAIX e-mall : idrubaix@nordnet.fr |
2. DEVICE DESCRIPTION
LIGAFIX® are resorbable cannulated screws made of ceramic (β-ΤCP) / polymer (Poly Lactic Acid) composite and designed for the interference fixation of grafts in anterlor cruciate ligament reconstruction.
To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise:
- 2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA)
- 3 head design: standard reduced -- rounded ಂ
- Diameters from 7 mm to 11 mm 0
- Lengths from 20 mm to 35 mm ం
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SPECIAL 510k
LIGAFIX® Interference screws
SCIENCE FOR BIO MATERIALS
LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.
3. INTENDED USE
"LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruclate ligament reconstruction."
4. SUBSTANTIAL EQUIVALENCE
The additional LIGAFIX® Interference screws have the same fundamental scientific technology, operating principle and intended use as previously cleared LIGAFIX® Interference screw K050407 and K061262.
Summary preparation date: February 13, 2007
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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2007
Science For Biomaterials % Mr. Denis Clement General Manager ZI du Monge F 65100 LOURDES, FRANCE
Re: K070507
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: February 16, 2007 Received: February 27, 2007
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 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.
3
Page 2 - Mr. Denis Clement
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrb/industry/support/index.html.
Sincerely yours,
Harbare Buellio
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SPECIAL 510k LIGAFIX® Interference screws
SCIENCE FOR BIO MATERIALS
Indications for Use
510(k) Number (if known):
Device Name: LIGAFIX® RESORBABLE INTERFERENCE SCREW
Indications for Use;
"LigaFix® interference screws are 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aubare bucher
Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K07507
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