(85 days)
Not Found
No
The summary describes a physical implantable device made of specific materials for surgical fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery," which directly addresses a medical condition or injury and restores function.
No
The device is described as an interference screw for fixation of grafts during ligament reconstruction surgery. This is a surgical implant, not a device used to diagnose a condition.
No
The device description clearly states it is a physical interference screw manufactured from composites, indicating it is a hardware device, not software.
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.
- Device Description: The BioactIF OSTEOTRANS™ Interference Screw is a physical implant used for surgical fixation of grafts during ligament reconstruction. It is a sterile, single-use screw made of specific materials.
- Intended Use: The intended use is for surgical fixation within the body, not for testing samples taken from the body.
The information provided clearly describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bonc-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.
Product codes
HWC
Device Description
The BioactIF OSTEOTRANS"M Interference Screw is a stcrile, single-use interference screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Screws are provided with various sizes typical of other marketed fixation devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance data demonstrate that the BioactIF OSTEOTRANS™ Interference Screw has the requisite strength and favorable degradation profile sufficient and sustained fixation for intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003641, K002070, K013572, K002274
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
K081390 page 192
AUG 1 2, 2008
510(k) Summary BioactIF OSTEOTRANS™M Interference Screw
| Submitter's name : | Takiron Co., Ltd. |
|---|---|
| Submitter's address: | 3-13 Azuchi-machi 2-chome, Chuo-ku, Osaka |
| 541-0052, Japan | |
| Contact Person : | Kunihiro Hata |
| Regulatory Affairs Specialist | |
| 7-1-19, Minatojimaminamimachi, Chuo-ku, | |
| Kobe, Hyogo, 650-0047, Japan | |
| Phone: +81 78 306 2601 | |
| Fax: +81 78 306 2606 | |
| Date prepared: | May 9, 2008 |
| Trade or proprietary name: | BioactIF OSTEOTRANSTM Interference Screw |
| Common or usual name: | Bioabsorbable interference screw |
| Classification name: | Bone fixation screw, Class II |
| Device product code: | HWC - 21 CFR 888.3040 Screw, Fixation, Bone |
Establishment Registration Number:
Takiron Co., Ltd. has not yet obtained an Establishment Registration Number.
Legally Marketed Predicate Devices:
-
- Biocomposites Ltd .; Biosteon™ Screw (K003641)
- Biocomposites Ltd.; BioLok® Scrcw (K002070) 2.
- Mitek Products; Mitek Biocryl Interference Screw (K013572) 3.
- Smith & Nephew Inc.; Smith & Nephew HAPLA Interference Screw (K002274) 4.
Intended Use:
The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bonc-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.
1
pye 24
Device Description:
The BioactIF OSTEOTRANS"M Interference Screw is a stcrile, single-use interference screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Screws are provided with various sizes typical of other marketed fixation devices.
Summary of Technology:
The BioactIF OSTEOTRANS"M Interference Screw has the same technological characteristics (i.e., design and material) when compared to the predicate devices. Performance data demonstrate that the BioactIF OSTEOTRANS™ Interference Screw has the requisite strength and favorable degradation profile sufficient and sustained fixation for intended uses.
Substantial equivalence
The BioactIF OSTEOTRANS™ Interference Screw is indicated for the same uses and anatomical regions as the predicate devices.
The BioactIF OSTEOTRANS™ Interference Screw has very similar physical design features and functional characteristics as the predicate devices.
Therefore the BioactIF OSTEOTRANSTM Interference Screw is substantially equivalent in design, materials and intended use and principles of operation to the predicate devices.
2
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 symbol on the right. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Takiron Co., Ltd % Mr. Kunihiro Hata Regulatory Affairs Specialist Medical Institute 7-1-19, Minatojimaminamimachi, Chuo-Ku, Kobe. Hyogo Japan 650-0047
AUG 1 2 2008
Re: K081390
Trade/Device Name: BioactIF OSTEOTRANS™ Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 9 2008 Received: May 19, 2008
Dear Mr. Kunihiro:
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. Kunihiro Hata
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 M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Applicant: Takiron Co., Ltd. Ko81390 510(k) Number (if known): Device Name: BioactIF OSTEOTRANS"M Interference Screw
Indications For Use:
The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.
Prescription Use______________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR 801.109)
Over-The-Counter Use_
(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
ваваше висина for мхп
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K081390
4-1