(30 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical fixation components (screws, plates) for spinal stabilization and fusion. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
This device is a screw fixation system intended to stabilize the spine as an aid to fusion for various conditions like trauma, spondylolisthesis, and degenerative diseases, which are therapeutic interventions.
No
The device is a screw fixation system intended to stabilize the spine as an aid to fusion, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states that the system consists of screws and plates fabricated from medical grade stainless steel or titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for stabilizing the spine as an aid to fusion through surgical fixation methods. This involves implanting a device into the body.
- Device Description: The device is described as screws and plates fabricated from medical-grade materials, designed to be implanted for spinal fixation.
- 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 treatment.
IVD devices are used outside the body to analyze biological samples. This device is an implantable surgical device.
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™ to rastor of two arreless 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 ttirough the bapers. Sico of a be is attached to the base of the spinous processes at the corresponding levels with 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 r or other mountaly and 15 (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 monder. (d) acgetient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
Product codes (comma separated list FDA assigned to the subject device)
MRW
Device Description
The TOWNLEY™ Transfacetpedicular Screw Fixation System consists of screws designed to compress bone grafts. 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 titanium alloy conforming to such standards as ASTM F-136 or ISO 5832-3. The screws may be used with or without DYNALOK plates. DYNALOK plates are used as spinous process plates 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 purpose of this submission is to add a 4.0mm titanium cortical bone screw to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to S1 (inclusive) spinal levels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
posterior surgical treatment
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): 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.
Not Found
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
N/A
0
DEC 1 9 2001
Ko13829
TOWNLEY™ Transfacetpedicular Screw Fixation System 510(k) Summary November 2001
- Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
- Proprietary Trade Name: TOWNLEY™ Transfacetpedicular Screw Fixation System II.
- Product Descriptiom: The TOWNLEY™ Transfacetpedicular Screw Fixation System consists of III. screws designed to compress bone grafts. 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 titanium alloy conforming to such standards as ASTM F-136 or ISO 5832-3. The screws may be used with or without DYNALOK plates. DYNALOK plates are used as spinous process plates 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 purpose of this submission is to add a 4.0mm titanium cortical bone screw to the system.
- 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 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 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 S1 (inclusive) spinal levels: 1) rauma, 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.
- Substantial Equivalence: Documentation was provided which demonstrated the TOWNLEY™ V. Transfacetpedicular Screw Fixation System to be substantially equivalent to itself.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2001
Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K013829
K013027
Trade/Device Name: TOWNLEY™ Transfacetpedicular Fixation System Product Code: MRW Dated: November 16, 2001 Received: November 19, 2001
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device We nave leviewed your bootion or susined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate comments indications for use stated in the eneround) it the Medical Device Amendments, or to prof to May 28, 1770, the charene and can es with the provisions of the Federal Food, devices mat nave been rochability in may, therefore, market the device, subject to the Drug, and Cosmetic Act (7tel). "Tou may) answeral controls provisions of the Act include general controls provisions of the Frida Stations 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 (Premarket Approval), it may be subject to such additional controls. Existing major (Fremarket Approvar), It may or saojoes for the Code of Federal Regulations, Title regulations articling your devivalent determination assumes compliance with 21, Falls 800 to 675. A substantially tigarequirement, as set forth in the Quality System
the current Good Manufacturing Practice requirement, as set forth and that the current Good Manafacturing Prasis. General regulation (21 CFR Part 820) and that, Regulation (QD) inspections, the Food and Drug Administration (FDA) will verify through periodic (QD) inspections, and the GMP regulation may result in regulatory Such assumptions. Funale to comply further announcements concerning your device in action: In addition, I Dlease note: this response to your premarket notification the recein Register. Treasonoter antion you might have under sections 531 through 542 Sublinssion act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Richard W. Treharne, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
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
000026
November 2001
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™ to rastor of two arreless 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 ttirough the bapers. Sico of a be is attached to the base of the spinous processes at the corresponding levels with 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 r or other mountaly and 15 (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 monder. (d) acgetient 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) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices |
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