(109 days)
Not Found
No
The description focuses on the material and mechanical properties of a bone staple, with no mention of AI or ML.
Yes
The device description and intended use/indications for use specify that the device is a long-term fixation staple implant used for fracture and osteotomy fixation and joint arthrodesis, which are therapeutic interventions.
No
The device is described as a "long-term fixation staple" used for "fracture and osteotomy fixation and joint arthrodesis," indicating it is a therapeutic implant for treating musculoskeletal injuries, not for diagnosing conditions.
No
The device description clearly states it is a "long-term fixation staple implant," which is a physical hardware device made of metal.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the fixation of bones and joints within the body (fracture and osteotomy fixation, joint arthrodesis). This is a surgical intervention performed directly on the patient's anatomy.
- Device Description: The device is described as long-term fixation staple implants made of a metal alloy. This is a physical implant designed to provide structural support within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with bodily specimens or diagnostic purposes.
The device is clearly a surgical implant used for orthopedic procedures, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
- Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- Fixation of proximal tibial metaphysis osteotomy
- Hand and foot bone fragment and osteotomy fixation and joint arthrodesis
- Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and in flat bone such as the pelvis, scapula and sternum.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The TiTHON Staples with OsseoTi Technology are long-term fixation staple implants. TiTHON Staples are available in widths of 15, 20 and 25mm, with leg lengths of 7, 10, 15, 20and 20mm. OsseoTi is a porous metal construct made of a Ti-6Al-4V alloy. The porous architecture mimics the porous structure of human cancellous bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand, foot, proximal tibial metaphysis, femur, fibula, tibia, humerus, ulna, radius, clavicle, ribs, pelvis, scapula, sternum.
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)
Non-Clinical Tests: o Mechanical testing has been performed in keeping with ASTM F564 Standard Specification and Test Methods for Metallic Bone Staples
Clinical Tests: o No clinical testing was provided to establish substantial equivalence
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 Bell Drive Warsaw. Indiana 46580
October 2, 2015
Re: K151615 Trade/Device Name: TiTHON Staple with OsseoTi Technology Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: September 8, 2015 Received: September 10, 2015
Dear Ms. Beres:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Patricia Sandborn Beres
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name TiTHON Staple with OsseoTi Technology
Indications for Use (Describe)
- · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- · Fixation of proximal tibial metaphysis osteotomy
- · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis
- · Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and in flat bone such as the pelvis, scapula and sternum.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
BIOMET
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the TiTHON Staple with OsseoTi Technology 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Patricia S. Beres
Senior Regulatory Specialist
(574) 257-6639 extension 1278 |
| Date: | September 29, 2015 |
| Subject Device: | Trade Name: TITHON Staple with OsseoTi Technology
Common Name: Bone Staple
Classification Name:
• IDB– Staple, Fixation, Bone (21 CFR888.3030) |
Legally marketed devices to which substantial equivalence is claimed:
- Speed™, Speed Shift™, Speed Titan™, Speed Arc™ - Biomedical Enterprises, Inc. -K142292
Device Description
The TiTHON Staples with OsseoTi Technology are long-term fixation staple implants. TiTHON Staples are available in widths of 15, 20 and 25mm, with leg lengths of 7, 10, 15, 20and 20mm. OsseoTi is a porous metal construct made of a Ti-6Al-4V alloy. The porous architecture mimics the porous structure of human cancellous bone.
Intended Use and Indications for Use
The TITHON OsseoTi Staple indications for use are:
- Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- Fixation of proximal tibial metaphysis osteotomy
- Hand and foot bone fragment and osteotomy fixation and joint arthrodesis
- Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
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Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The subject device and the predicate device are both intended for bone fixation
- Indications for Use: The subject device and the predicate have identical indications for use
- Materials: Both devices are manufactured from titanium alloy
- Design Features: The subject device has similar design features to that of the predicate
- . Sterilization: Both devices are provided sterile by gamma irradiation
Summary of Performance Data (Nonclinical and/or Clinical)
- Non-Clinical Tests
- o Mechanical testing has been performed in keeping with ASTM F564 Standard Specification and Test Methods for Metallic Bone Staples
- . Clinical Tests
- o No clinical testing was provided to establish substantial equivalence
Substantial Equivalence Conclusion
The proposed device has similar technological characteristics to the predicate, and the information provided demonstrates that any differences do not raise new questions of safety and effectiveness and that the proposed device is at least as safe and effective as the legally marketed predicate device.