(62 days)
Not Found
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is a system of screws and plates intended to stabilize the spine and aid in fusion, addressing various spinal conditions like trauma, spondylolisthesis, and degenerative diseases, which are therapeutic indications.
No
The device is a surgical fixation system intended to stabilize the spine as an aid to fusion, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of screws and potentially plates, which are physical hardware components used in surgical procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to stabilize the spine as an aid to fusion. This is a therapeutic device used directly on the patient's body during surgery.
- Device Description: The device description details screws and plates made from medical-grade materials, intended for physical fixation within the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The TOWNLEY™ Transfacetpedicular Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TOWNLEY™ Transfacetpedicular Screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle.
In the second fixation method, the TOWNLEY™ Transfacetpedicular Screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the same time that a DYNALOK® Plate is attached to the base of the spinous processes at the corresponding levels with TOWNLEY™ Transfacetpedicular Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods.
For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the C2 to T3 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or: (b) degenerative disease of the facets with instability.
Product codes
MRW
Device Description
The TOWNLEY™ Transfacetpedicular Screw Fixation System consists of screws designed to compress bone grafts. Both cortical and cancellous screw threads are available. The screws are fabricated from medical grade stainless steel described by such standards as ASTM F-138 or ISO 5832-1 or ISO 5832-9, or of titanium alloy described by such standards as ASTM F-136 or ISO 5832-3. The screws may or may not be used in conjunction with DYNALOK plates. When DYNALOK plates are used they are used to connect two or more screws together on one side of the spine at the base of the spinous process when the system is used for the second fixation method described below. Stainless steel and titanium implant components should never be used in the same construct. The sole purpose of this submission is to reduce the indications of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to T3 (inclusive) spinal levels
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
CONFIDENTIAL
JUL 2 4 2002
TOWNLEY™ Transfacetpedicular Screw Fixation System
510(k) Summarv May 2002
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I. Company: Medtronic Sofamor Danek USA. Inc. 1800 Pyramid Place Memphis. TN 38132 (901) 396-3133
021705
page 1 of 1 -
Proprietary Trade Name: TOWNLEY™ Transfacetpedicular Screw Fixation System II.
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Product Descriptiom: The TOWNLEY™ Transfacetpedicular Screw Fixation System consists of III. screws designed to compress bone grafts. Both cortical and cancellous screw threads are available. The screws are fabricated from medical grade stainless steel described by such standards as ASTM F-138 or ISO 5832-1 or ISO 5832-9, or of titanium alloy described by such standards as ASTM F-136 or ISO 5832-3. The screws may or may not be used in conjunction with DYNALOK plates. When DYNALOK plates are used they are used to connect two or more screws together on one side of the spine at the base of the spinous process when the system is used for the second fixation method described below. Stainless steel and titanium implant components should never be used in the same construct. The sole purpose of this submission is to reduce the indications of the system.
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Indications: The TOWNLEY™ Transfacetpedicular Screw Fixation System is intended to stabilize IV. the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TOWNLEY™ Transfacetpedicular Screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle.
In the second fixation method, the TOWNLEY™ Transfacetpedicular Screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the same time that a DYNALOK @ Plate is attached to the spinous processes at the corresponding levels with TOWNLEY™ Transfacetpedicular Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods.
For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the C2 to T3 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations: 2) Spondylolisthesis: 3) Spondylolysis: 4) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or; (b) degenerative disease of the facets with instability.
- V. Substantial Equivalence: Documentation was provided which demonstrated the TOWNLEY™ Transfacetpedicular Screw Fixation System to be substantially equivalent to itself.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring three stylized human profiles facing to the right, stacked on top of each other.
JUL 2 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132
Re: K021705
Trade/Device Name: TOWNLEY™ Transfacetpedicular Screw Fixation System Regulatory Class: unclassified Product Code: MRW Dated: June 20, 2002 Received: June 25, 2002
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 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.
2
Page 2 - Richard W. Treharne, Ph.D.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark H. Milkeerson
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
3
Page 1 of 1
May 2002
510(k) Number (if known):
Device Name: TOWNLEY™ Transfacetpedicular Screw Fixation System
Indications for Use:
The TOWNLEY™ Transfacetpedicular Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TOWNLEY™ Transfacetpedicular Screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle.
In the second fixation method, the TOWNLEY™ Transfacetpedicular Screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the same time that a DYNALOK® Plate is attached to the base of the spinous processes at the corresponding levels with TOWNLEY™ Transfacetpedicular Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods.
For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the C2 to T3 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or: (b) degenerative disease of the facets with instability.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Mark N Milbern
and Neurological Dev
510(k) Number K021705