(54 days)
KWP, MNH
Not Found
No
The device description and intended use clearly define a mechanical spinal fixation system made of metal components. There is no mention of software, algorithms, or any technology that would suggest AI/ML capabilities.
Yes
The device is intended to treat severe spondylolisthesis, degenerative disc disease, pseudarthrosis, stenosis, spondylolisthesis, spinal deformities, fracture, unsuccessful previous attempts at spinal fusion, and tumor resection, and to provide temporary stabilization and augment spinal fusion. These are all therapeutic actions.
No
The device description clearly states its purpose is to provide temporary, bilateral stabilization and augment spinal fusion, which are treatment functionalities, not diagnostic ones.
No
The device description explicitly states the system comprises physical components like clamps, cross connectors, nuts, and screws made of titanium alloy or stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to provide temporary stabilization and augment spinal fusion. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details physical components like clamps, connectors, nuts, screws, rods, and plates made of medical-grade materials. These are all components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar -- first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only: (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and/or (d) who are having the device removed after the development of a solid fusion mass.
TENOR™ Plates are intended for the L5-S1 pedicle screw indication described above only.
The TENORTM Spinal System, when used as a non-pedicle screw fixation system, is intended for the following indications: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) pseudarthrosis, 3) stenosis, 4) spondy|olisthesis, 5) spinal deformities: scoliosis, kyphosis, 6) fracture, 7) unsuccessful previous attempts at spinal fusion, and/or 8) tumor resection. When used for posterior non-pedicle screw fixation, the TENORTM System is intended for thoracic, lumbar, and sacral (T1-Sacrum) fixation only.
Product codes
KWP, MNH
Device Description
The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross connectors, nuts, and screws made of medical grade titanium alloy or stainless steel. The TENOR™ Spinal System is used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON( Low Profile MULTI-SPAN™ CROSSLINK® plates and/or MULTI AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.
The purpose of this submission is to include additional screws to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fifth lumbar -- first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 to sacrum), thoracic, lumbar, and sacral (T1-Sacrum)
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)
Documentation was provided that demonstrated the TENOR™ Spinal System to be substantially equivalent to itself.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
AUG 2 8 2002
K022/91
page 1 of 1
TENOR™ Spinal System 510(k) Summary August 2002
I. Medtronic Sofamor Danek USA Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
II. Proposed Proprietary Trade Name: TENOR™ Spinal System
- III. Classification Name: Orthosis, Spondylolisthesis Spinal Fixation (per 21 CFR Section 888.3070)
IV. Product Description
The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross connectors, nuts, and screws made of medical grade titanium alloy or stainless steel. The TENOR™ Spinal System is used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON( Low Profile MULTI-SPAN™ CROSSLINK® plates and/or MULTI AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.
The purpose of this submission is to include additional screws to the system.
V. Indications
The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar -- first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only: (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and/or (d) who are having the device removed after the development of a solid fusion mass.
TENOR™ Plates are intended for the L5-S1 pedicle screw indication described above only.
The TENORTM Spinal System, when used as a non-pedicle screw fixation system, is intended for the following indications: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) pseudarthrosis, 3) stenosis, 4) spondy|olisthesis, 5) spinal deformities: scoliosis, kyphosis, 6) fracture, 7) unsuccessful previous attempts at spinal fusion, and/or 8) tumor resection. When used for posterior non-pedicle screw fixation, the TENORTM System is intended for thoracic, lumbar, and sacral (T1-Sacrum) fixation only.
VI. Substantial Equivalence
Documentation was provided that demonstrated the TENOR™ Spinal System to be substantially equivalent to itself.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
Mr. Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K022191
Trade/Device Name: TENOR® Spinal System Regulation Number: 21 CFR §888.3050 and §888.3070 Regulation Name: Spinal interlaminal fixation orthosis and Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP and MNH Dated: July 3, 2002 Received: July 5, 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 – Mr. 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) 594-4659. 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" (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,
R. Mark N. Milliken
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
3
510/k) Number (if known): KO22 (9)
TENOR™ Spinal System Device Name:
Indications for Use:
The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar -- first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and/or (d) who are having the device removed after the development of a solid fusion mass.
TENOR™ Plates are intended for the L5-S1 pedicle screw indication described above only.
The TENOR™ Spinal System, when used as a non-pedicle screw fixation system, is intended for the following indications: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) pseudatthrosis, 3) stenosis, 4) spondylolisthesis, 5) spinal deformities: scoliosis, lordosis, 6) fracture, 7) unsuccessful previous attempts at spinal fusion, and/or 8) tumor resection. When used for posterior non-pedicle screw fixation, the TENOR™ Spinal System is intended for thoracic, lumbar, and sacral (T1-Sacrum) fixation only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)
OR
Over-the-counter Use
Mark N Millman
ivision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K0221960047