(138 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes.
This device is designed to temporarily stabilize the spine and augment spinal fusion, treating various conditions such as degenerative disc disease, fractures, and deformities, which are therapeutic actions.
No
The device is described as a "supplemental fixation device" and "temporary implant" used for "correction and stabilization of the spine" and to "help provide temporary stabilization until a solid spinal fusion develops." It is a physical implant designed to treat conditions, not to diagnose them.
No
The device description explicitly states it consists of physical components like plates, screws, and instrument sets made from medical grade titanium alloy, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a "temporary implant used for the correction and stabilization of the spine" and a "supplemental fixation device consisting of a variety of sizes of plates, and screws". Its intended use is for surgical implantation to stabilize the lumbosacral spine.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, the T-PLATE ANTERIOR PLATE FIXATION SYSTEM is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
Product codes
KWO, KWQ
Device Description
The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)) is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made from medical grade titanium alloy. Stainless steel and titanium components must not be used together in a construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral level below the bifurcation of the vascular structures, spinal, thoracolumbar, lumbar
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)
Mechanical testing was performed on the The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)), which determined it to be substantially equivalent to the T-PLATE ANTERIOR PLATE FIXATION SYSTEM.
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
§ 888.3060 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.
0
T-PLATE Anterior Fixation System 510(K) Summary August 2007
ESM Technologies, LLC. I. Company: 403 Farwell Drive Madison, WI 53704
DEC 2 & 2007
- Cliff Tribus, MD Contact: President, ESM Technologies Telephone: 608 467-8324 Cell: 608 332-8521 e-mail: ctribus@esmtech.com
II. Proprietary Trade Name: T-PLATE Anterior Fixation System Proposed Name of Modified Devices: The T-PLATE ANTERIOR PLATE Fixation System: 1. The Translation Plate Phase 1 (T-1 plate) 2. The Translation Plate Phase 2 (T-2 plate) Classification Name: Spinal Intervertebral Body Fixation Orthosis (per 21 CFR
Section 888.3060 Product Codes: KWO
Predicate (unmodified) Device: The T-PLATE ANTERIOR PLATE Fixation System K051764, July 13, 2005
III. Product Description
The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)) is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) components can be locked into a variety of configurations, with
1
each construct being tailor-made for the individual case. The implant components are made from medical grade titanium alloy. Stainless steel and titanium components must not be used together in a construct.
IV. Indications
The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
V. Substantial Equivalence
Mechanical testing was performed on the The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)), which determined it to be substantially equivalent to the T-PLATE ANTERIOR PLATE FIXATION SYSTEM. (K051764, July 13, 2005)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter.
Public Health Service
DEC 2 € 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ESM Technologies, LLC % Cliff Tribus. M.D. President, ESM Technologies 403 Farwell Drive Madison, WI 53704
Re: K072231
Trade/Device Name: T-PLATE Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 10, 2007 Received: December 12, 2007
Dear Dr. Tribus:
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.
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Page 2 - Cliff Tribus, M.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), 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulkerson
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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Indications for Use
510(k) Number (if known): K072231
Device Name:
T-PLATE Anterior Fixation System
-
- The Translational Plate Phase 1 (T-1 plate)
-
- The Translational Plate Phase 2 (T-2 plate)
Indications For Use:
The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Boubane Buelup
Division Sign Off
Division of General, Rest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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August 2007
510(k) Number K0722631