K Number

Device Name

MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR

Manufacturer

DANEK MEDICAL, INC.

Date Cleared

1999-05-28

(25 days)

Product Code

MNH

Regulation Number

888.3070

Intended 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 (d) who are having the device removed after the development of a solid fusion mass. TENOR™ Plates are intended for the LS-S1 pedicle screw indication described above only. The TENOR™ Spinal System, when used as a posterior 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.) Spondylolisthesis, 5.) Spinal deformities: scoliosis, lordosis, 6.) Fracture, 7.) Unsuccessful previous attempts at spinal fusion, 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.

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, connectors, cross-connectors, nuts, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORM Spinal System may be 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is described as a "spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion," indicating its use in treating medical conditions.

Diagnostic

The TENOR™ Spinal System is a spinal device intended to provide temporary stabilization and augment spinal fusion. It is used in surgical procedures and does not perform diagnostic functions.

SaMD (Software as a Medical Device)

The device description explicitly states the system comprises various hardware components like clamps, connectors, plates, and screws made of titanium alloy or stainless steel.

IVD (In Vitro Diagnostic)

Based on the provided information, the TENOR™ Spinal System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
TENOR™ Spinal System Description: The description clearly states that the TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment spinal fusion. It is a physical implant made of metal components.
Intended Use: The intended use describes surgical procedures for stabilizing the spine in patients with specific conditions. It does not involve the analysis of biological specimens.

Therefore, the TENOR™ Spinal System falls under the category of a surgical implant or medical device used in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TENOR™ Plates are intended for the LS-S1 pedicle screw indication described above only.

The TENOR™ Spinal System, when used as a posterior 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.) Spondylolisthesis, 5.) Spinal deformities: scoliosis, lordosis, 6.) Fracture, 7.) Unsuccessful previous attempts at spinal fusion, 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.

Product codes

MNH, KWP

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fifth lumbar – first sacral (LS-S1) vertebral joint, lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum), posterior thoracic and lumbar spine, 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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself.

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Summary

MAY 28 1999

Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: TENOR™ Spinal System II.

Product Description III.

IV. Indications

TENOR™ Plates are intended for the LS-S1 pedicle screw indication described above only.

V. Substantial Equivalence

Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself.

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three parallel lines that curve and taper towards the right, resembling a bird in flight or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 1999

Richard W. Treharne, Ph.D. Vice President, Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132

Re: K991528

Trade Name: TENOR™ Spinal System Regulatory Class: II Product Codes: MNH and KWP Dated: April 30, 1999 Received: May 3, 1999

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 toll-free 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.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

TENORIM Spinal System Device Name: _

Indications for Use:

TENOR™ Plates are intended for the LS-S1 pedicle screw indication described above only.

The TENOR™ Spinal System, when used as a posterior, 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. Spondylolisthesis; 5. Spinal deformities: scoliosis, kyphosis, lordosis; 6. Fracture; 7. Unsuccessful previous attempts at spinal fusion; 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)

f Evaluation (ODE)

To: Office

(Division Sign-Off)
Div General Restorative Devices
510(k) Number K99 152

STORK) Number _

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

Over-the-counter Use

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