(88 days)
Not Found
No
The device description and performance studies focus on mechanical fixation and strength, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a "Fixation System" for securing tendon grafts during ACL and PCL reconstructions, which are surgical procedures, not processes that directly treat or mitigate a disease or condition. It acts as an anchor for the graft.
No
Explanation: The device is designed for the fixation of tendon grafts during surgical procedures (ACL and PCL reconstructions), which is a treatment function, not a diagnostic one. It does not mention identifying or assessing a medical condition.
No
The device description explicitly lists hardware components (screw, tape, passing wires, tape support) that are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of tendons graft to the femur and tibia during orthopaedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions." This describes a surgical implant and associated tools used in vivo (within the body) during a surgical procedure.
- Device Description: The components listed (screws, tape, wires, support) are all physical devices used to facilitate the surgical reconstruction of ligaments. They are not used to test samples of bodily fluids or tissues in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device clearly falls outside that category.
N/A
Intended Use / Indications for Use
The TLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopaedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.
Product codes
HWC, MBI, JDR
Device Description
The TLS® Fixation System is composed of the following elements:
- The TLS® screw, used for the fixation of the TLS® tape to the bone.
- The TLS®+ tendon fixation tape kit, for the ACL and PCL reconstruction, to which the tendon graft is attached.
This kit is composed of:
- 1 non-absorbable tape : implantable,
- 2 passing wires: non implantable, to be used to pass the tape and the attached graft through the bone tunnel,
- 1 tape support: non implantable, to be used for the preparation of the graft.
The following table details our fixation screws and our non-absorbable surgical suture:
Products: TLS® Screw
Materials: Titanium alloy
Sizes: Ø10 Length 20, 25mm
To be implanted: Yes
Products: TLS®+ tendon fixation tape kit - Tape
Materials: Poly[ethylene terephtalate]
Sizes: Length: 60cm, Width: 6 cm
To be implanted: Yes
Products: TLS®+ tendon fixation tape kit - Passing wires
Materials: Poly[ethylene terephtalate]
Sizes: Length: 50 cm, Ø 0.7mm
To be implanted: No
Products: TLS®+ tendon fixation tape kit - Tape support
Materials: Anodized aluminium
Sizes: -
To be implanted: No
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur and tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic surgical procedures
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
The TLS® Fixation System was tested against the EndoButton to determine if it was equivalent in strength. Tensile Strength, Stiffness and Cyclic Fatigue Testing were examined. After the testing was completed, it was determined that the TLS® Fixation System is as strong as the currently marketed EndoButton™.
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
JUL - 1 2008
5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.
Date prepared : February 25th 2008
The assigned 510(k) number is: K080774
5-1. SUBMITTER :
Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernévez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13
5-2. COMPANY CONTACT :
Franck HUNT, General Manager Tel: (+33) 2.98.55.68.95
5-3. DEVICE NAME :
Trade name : TLS® Fixation System Common name : Fixation screw and Non absorbable surgical suture Classification name : - Non absorbable surgical suture (Poly[ethylene terephtalate]): Regulation: 21 CFR 878.5000 / Procode: GAT - Fixation screw: Regulation: 21 CFR 888.3040 / Procode: HWC
5-4. PREDICATE/ LEGALLY MARKETED DEVICES :
> Non-absorbable suture :
| Manufacturer : | Smith & Nephew |
|---|---|
| Device Trade Name : | EndoButton™ Continuous Loop |
| 510 (K) : | K980155 |
| Date cleared : | 04/01/1998 |
| Manufacturer : | F.H INDUSTRIE |
|---|---|
| Device Trade Name : | Tenolig® |
| 510 (K) : | K060367 |
| Date cleared : | 09/08/2006 |
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> Fixation screw:
| Manufacturer : | Smith & Nephew |
|---|---|
| Device Trade Name : | RCiTM screw |
| 510 (K) : | K992945 |
| Date cleared : | 11/18/1999 |
5-5. DEVICE DESCRIPTION:
The TLS® Fixation System is composed of the following elements:
- The TLS® screw, used for the fixation of the TLS® tape to the bone. -
- The TLS®+ tendon fixation tape kit, for the ACL and PCL reconstruction, to which the tendon graft is attached.
This kit is composed of:
- = 1 non-absorbable tape : implantable,
- · 2 passing wires: non implantable, to be used to pass the tape and the attached graft through the bone tunnel,
- · 1 tape support: non implantable, to be used for the preparation of the graft.
The following table details our fixation screws and our non-absorbable surgical suture:
| Products | | Materials | Sizes | To be
implanted |
|-----------------------------------|------------------|--------------------------------|------------------------------|--------------------|
| TLS® Screw | | Titanium
alloy | Ø10
Length 20,
25mm | Yes |
| TLS®+ tendon fixation tape
kit | Tape | Poly[ethylene
terephtalate] | Length: 60cm,
Width: 6 cm | Yes |
| | Passing
wires | Poly[ethylene
terephtalate] | Length: 50 cm,
Ø 0.7mm | No |
| | Tape
support | Anodized
aluminium | - | No |
5-6. INDICATIONS FOR USE/ INTENDED USE:
The TLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopaedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.
5-7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
The TLS® screws and the TLS®+ tendon fixation tape have the same intended use and substantial similar indications for use as the predicate devices selected. The products are all made of the same material (titanium alloy and polyethylene terephtalate), are available in similar diameters and lengths, with similar designs.
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5-8. PERFORMANCES:
The TLS® Fixation System was tested against the EndoButton to determine if it was equivalent in strength. Tensile Strength, Stiffness and Cyclic Fatigue Testing were examined. After the testing was completed, it was determined that the TLS® Fixation System is as strong as the currently marketed EndoButton™.
Risk to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
5-9. SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of our products when compared to the selected predicate devices has been established following manufacturers' commercial documents and 510(k) submission's information available on FDA's website.
| Characteristics | TLS® tape | ENDOBUTTON™ CL | TENOLIG® |
|---|---|---|---|
| Manufacturer | F.H. industrie | Smith & Nephew | F.H. industrie |
| 510(k) number | Pending | K980155 | K060367 |
| Indications for Use | Used for ACL and PCL | ||
| reconstruction | Used for ACL and PCL | ||
| reconstruction | Indicated for surgical | ||
| repair of Achille tendon | |||
| ruptures by percutaneous | |||
| approach | |||
| Material | Polyethylene terephtalate | Polyethylene terephtalate | Polyethylene terephtalate |
| Lengths | 60 cm | 10 to 80 cm | 36 cm |
| Diameter | 6 mm | 6 to 12 mm | 0,85mm |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Single Use | Yes | Yes | Yes |
Tables of Substantial Equivalence
| Characteristics | TLS® screw | Rci™ screw |
|---|---|---|
| Manufacturer | F.H. industrie | Smith & Nephew |
| 510(k) number | Pending | K992945 |
| Indications for Use | Graft fixation for ACL and | |
| PCL reconstruction | Graft fixation for ACL and | |
| PCL reconstruction | ||
| Material | Titanium alloy | Titanium alloy |
| Lengths | 20 to 25 mm | 25 to 50 mm |
| Diameter | 10 mm | 6 to 12 mm |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Single Use | Yes | Yes |
5-10. CONCLUSION:
Following the examination of all the above mentioned information, we can then conclude that the TLS® Fixation System composed of the TLS® screw and the TLS®+ tendon fixation tape are substantially equivalent to the selected predicate devices in terms of materials, intended use, performances, safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fournitures Hospitalieres Industrie % Mr. Franck Hunt General Manager ZI de Kernevez 6 rue Nobel 29000 Quimper France
JUL - 1 2008
Re: K080974 Trade/Device Name: TLS® Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR Dated: February 25, 2008 Received: April 4, 2008
Dear Mr. Hunt:
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.
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Page 2 - Mr. Franck Hunt
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Mullean
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use
510(k) Number (if known):
Device Name :
TLS® Fixation System
KO80974
This product is composed of the following elements:
- The TLS® screw, ー
The TLS+® tendon fixation system -(1 tape , 2 passing wires, 1 tape support)
Indications for Use:
The TLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopaedic procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.
| Prescription Use: | Yes (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)
(Division Sign-Off)
Division of General
Concurrence of CDRH, Office of Device Evaluation (ODE) Page of
and Neurological
510(k) Number: K080974