(18 days)
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No
The document describes a mechanical implant (bone graft washer) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to aid spinal fusion and provide temporary stabilization, which are therapeutic actions.
No
The device description indicates that the BONE GRAFT WASHER is a temporary implant used to stabilize bone grafts and aid spinal fusion, which are therapeutic rather than diagnostic functions.
No
The device description clearly states it is a "temporary implant" and consists of "washers used with a screw," indicating it is a physical hardware device.
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.
- Device Description: The provided text describes a physical implant (BONE GRAFT WASHER) used in a surgical procedure to stabilize bone grafts during spinal fusion. It is a temporary implant placed within the body.
The intended use and device description clearly indicate that this is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).
Product codes
KWO
Device Description
The BONE GRAFT WASHER is a temporary implant used to prevent bone graft extrusion. The washer is also intended to provide temporary stabilization and augment development of a solid spinal fusion. The BONE GRAFT WASHER consists of a variety of sizes of washers used with a screw.
The purpose of this submission is to make include modified washers and an additional screw to the system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
T1-S1 (spinal fusion)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Documentation was provided which demonstrated the BONE GRAFT WASHER to be substantially equivalent to itself.
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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BONE GRAFT WASHER 510(k) Summary May 2004
- Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proprietary Trade Name: BONE GRAFT WASHER II.
Regulation Number: 888.3060 - KWQ III.
IV. Product Description
The BONE GRAFT WASHER is a temporary implant used to prevent bone graft extrusion. The washer is also intended to provide temporary stabilization and augment development of a solid spinal fusion. The BONE GRAFT WASHER consists of a variety of sizes of washers used with a screw.
The purpose of this submission is to make include modified washers and an additional screw to the system.
V. Indications
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (c.g., commercially pure titanium or titanium alloy).
VI. Substantial Equivalence
Documentation was provided which demonstrated the BONE GRAFT WASHER to be substantially equivalent to itself.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three heads, representing the department's focus on health and well-being. The figure is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircling it. The logo is simple, yet recognizable, and is used to represent the department's mission and values.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2004
Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K041217
Trade Name: Bone Graft Washer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: Class II Product Code: KWO Dated: June 17, 2003 Received: June 18, 2003
Dear Dr. Treharne:
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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Rick Treharne
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html.
Sincerely yours,
Mark A. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K041217 510(k) Number (if known): BONE GRAFT WASHER Device Name:
Indications for Use:
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S I ) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Wilkerson
Division of General, Restorative, and Neurological Devices
510(k) Number K041217