When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease(defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3)fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal 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) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudoarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion. When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
Device Story
TSRH® Spinal System is a modular orthopedic implant set for spinal immobilization and fusion. Components include rods, hooks, screws, cross connectors, staples, and plates. Subject device adds a 3Dx 90° Offset Connector to existing system. System components are assembled into patient-specific constructs to provide rigid fixation. Used in clinical settings by surgeons; implanted via posterior or anterior surgical approaches. Provides mechanical stabilization of spinal segments to facilitate bone fusion. Benefits include correction of spinal deformities and stabilization of fractured or degenerated vertebrae.
Clinical Evidence
Bench testing only. No clinical data provided. Mechanical testing performed per ASTM F1798-97 (axial grip, axial torsion, flexion-extension) and ASTM F1717-04 (compression bending fatigue) to verify structural equivalence of the 3Dx 90° Offset Connector.
Indicated for skeletally mature patients requiring spinal immobilization/fusion (thoracic, lumbar, sacral). Conditions: degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, spinal stenosis, spondylolysis. Specific pedicle screw criteria: L5-S1 severe spondylolisthesis, autogenous bone graft use, L3 and below fixation, removal post-fusion.
Regulatory Classification
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.
Special Controls
*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.
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# TSRH® Spinal System 510(k) Summary
## September 9, 2010
SEP 3 0 2010
l. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
> Contact: Lila Joe Sr. Regulatory Affairs Specialist
- II. Proposed Proprietary Trade Name: TSRH® Spinal System
- III. Classification Name(s): Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, and Pedicle Screw Spinal System (per 21CFR Section 888.3050, 888.3060, and/or 888.3070); Product Code(s): KWP, MNI, MNH, NKB
- IV. Description:
The TSRH® Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, GDLH®set screws and locking screws, DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ screws are intended for posterior use only. ALL CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
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The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobaltchromium-molybdenum alloy. Medical grade titanium alloy, and/or cobaltchromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium allov, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
#### V. Indications for Use:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease(defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3)fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal 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) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudoarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
{2}------------------------------------------------
#### VI. Summary of the Technological Characteristics
TSRH® 3Dx 90° Offset Connector
The purpose of this 510(k) submission is to include a 3Dx 90° Offset Connector to the TSRH® Spinal System. A TSRH® 90° Offset Connector (K030285, S.E. 02/25/2003) is used as a predicate for geometrical comparison. Another TSRH® 90° Offset Connector (K030285, S.E. 02/25/2003), two TSRH® Standard Connectors (K030285, S.E. 02/25/2003 and K021170, S.E. 07/16/2002), and a CD HORIZON® Multi-Axial Screw (K052054, S.E. 08/19/2005) are used for comparison in mechanical testing.
The main difference between the two predicate TSRH® 90° Offset Connectors and the subject 90° Offset Connector is that the subject device is designed to accept the screw vertically while the predicate 90° offset connectors accept the set screw at an angle. Picture 1 below illustrates the subject and predicate devices.
Image /page/2/Picture/5 description: The image shows two devices, one labeled as the "Subject Device" and the other as "Predicate Devices". The "Subject Device" has a vertical attachment labeled "Vertical", while the "Predicate Devices" has an angled attachment labeled "Angle". Both devices appear to be made of metal and have a similar design with cylindrical sections and a central opening.
Picture 1: Subject Connector vs. TSRH® 90° Offset Predicate Connectors
The main difference between the subject connector and the TSRH® Standard Connectors is that the bone screw is assembled to the standard connector along side the rod while, for the subject 90° offset connector, the bone screw sits 90° offset the rod. Also, the subject device is designed to accept the screw vertically while the predicate standard connectors accept the set screw at an angle.
{3}------------------------------------------------
#### VII. Identification of Legally Marketed Devices:
TSRH® 3Dx 90° Offset Connector
Documentation was provided demonstrating that the TSRH® Spinal System is substantially equivalent to other commercially available fixation systems including TSRH® Spinal System in K021170 (S.E. 07/16/2002), K030285 (S.E. 02/25/2003), and CD HORIZON® Spinal System in K052054 (S.E. 08/09/2005).
### VIII. Discussion of the Non-Clinical Testing
TSRH® 3Dx 90° Offset Connector
Medtronic believes that documentation provided demonstrates that the TSRH® 3Dx 90° Offset Connector is substantially equivalent to it predicates which were cleared in the TSRH® Spinal System.
The tests that were performed per ASTM F1798-97, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants, were axial grip around the rod, axial grip around the screw, axial torsion about the rod and flexion extension static.
The test that was performed per ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, was compression bending fatigue.
{4}------------------------------------------------
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the wings and a wavy line representing the body.
### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA % Ms. Lila Joe Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
SEP 3 0 2010
Re: K101772
Trade/Device Name: TSRH® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: September 09, 2010 Received: September 13, 2010
Dear Ms. Joe:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
{5}------------------------------------------------
## Page 2 - Ms. Lila Joe
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
| 510(k) Number (if known): | K101772 |
|---------------------------|---------------------|
| Device Name: | TSRH Spinal System |
K101772 SEP 30 2010
### Indications for Use:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal 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) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region. the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
Prescription Use X OR Per 21 CFR 801.109
Over-The-Counter Use ------
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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