(172 days)
Not Found
No
The 510(k) summary describes a bone screw made of HA/PLLA composite and its mechanical properties for fracture fixation. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making.
Yes
The device is intended for the maintenance of alignment and fixation of various fractures and osteotomies, which is a therapeutic purpose.
No
Explanation: The device is a bone screw intended for the maintenance of alignment and fixation of fractures, osteotomies, arthrodeses, or bone grafts. It is a fixation device, not a diagnostic one.
No
The device description clearly states it is a sterile, single-use bone screw manufactured from physical materials (composites of hydroxyapatite and poly-L-lactide). It is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the fixation and alignment of bone fractures and osteotomies. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone screw made of composite materials. This is a physical implant used to stabilize bone.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests 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 tests.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The OSTEOTRANS™-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or bone grafts, including phalangeal fractures, metacarpal fractures, carpal fusion and fractures, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies, and correction of hallux valgus.
Product codes
HWC - 21 CFR 888.3040 Screw, Fixation, Bone, HTN - 21 CFR 888.3030 Washer, Bolt Nut
Device Description
The OSTEOTRANS™ OT Screw is a sterile, single-use bone screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). There are solid screws, cannulated screws and corresponding washers. Screws and washers are provided with various shapes and sizes typical of other marketed fixation devices.
Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Screws maintain accurate alignment of bone fractures and osteotomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalangeal, metacarpal, carpal, wrist, distal radius, olecranon, radial head, malleolus, ankle, metatarsal, hallux valgus
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 OSTEOTRANS™ OT Screw has the requisite strength and favorable degradation profile to provide sufficient and sustained bone fixation for intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
1073312 (pg 1/2)
510(k) Summary OSTEOTRANS™-OT Screw
MAY 1 3 2008
| 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: | November 15, 2007 |
| Trade or proprietary name: | OSTEOTRANS TM-OT Screw |
| Common or usual name: | Bioabsorbable bone fixation screw |
| Classification name: | Bone fixation screw, Class II |
| Device product code: | HWC - 21 CFR 888.3040 Screw, Fixation, |
| Bone | |
| HTN - 21 CFR 888.3030 Washer, Bolt Nut |
Establishment Registration Number:
Takiron Co., Ltd. has not yet obtained an Establishment Registration Number.
Legally Marketed Predicate Devices:
- Bionx Implants Ltd.; SmartScrew (K003077) 1.
- Cambridge Scientific, Inc.; WISORBTM Malleolar Screw (K020222) 2.
- Biocomposites Ltd.; Little Grafter " Screw (K040265) 3.
Intended Use:
The OSTEOTRANS™-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or bone grafts, including phalangeal fractures, metacarpal fractures, carpal fusion and fractures, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies, and correction of hallux valgus.
1
K073312 (pg 2/2)
Device Description:
The OSTEOTRANSTM OT Screw is a sterile, single-use bone screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). There are solid screws, cannulated screws and corresponding washers. Screws and washers are provided with various shapes and sizes typical of other marketed fixation devices.
Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Screws maintain accurate alignment of bone fractures and osteotomies.
Summary of Technology:
The OSTEOTRANS™-OT Screw has the same technological characteristics (i.e., design and material) when compared to the predicate devices.
Performance data demonstrate that the OSTEOTRANS™ OT Screw has the requisite strength and favorable degradation profile to provide sufficient and sustained bone fixation for intended uses.
Substantial equivalence
The OSTEOTRANS™-OT Screw is indicated for the same uses and anatomical regions as the predicate devices.
The OSTEOTRANSTM-OT Screw has very similar physical design features and functional characteristics as the predicate devices.
Therefore the OSTEOTRANSTM-OT 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 features a stylized eagle with its wings spread, symbolizing protection and care. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 13 2008
Takiron Co., LTD c/o Mr. Kunihiro Hata Medical Division 7-1-19, Minatojimaminamimachi, Chuo-Ku, Kobe, Hyogo Japan 650-0047
K073312 Trade/Device Name: OSTEOTRANS™ -OT Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: April 24, 2008 Received: April 24, 2008
Dear Mr. Hata:
Re:
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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO733126pg1/17
INDICATIONS FOR USE
Applicant: Takiron Co., Ltd. 510(k) Number (if known): K073312 OSTEOTRANS 10-OT Screw Device Name:
Indications For Use:
The OSTEOTRANS "-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or bone grafts, including phalangeal fractures, metacarpal fractures, carpal fusion and fractures, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies, and correction of hallux valgus.
Prescription Use_ X (Per 21 CFR 801.109)
OR 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)
Milke Oglr fr
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K073312
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