(28 days)
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH®Spinal System is indicated for one or more of the following: (1) degencrative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic sudies), (2) degenerative spondylolisthesis with objective evidence of neurologic impartment, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, 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 (15-S1) 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 (LS 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) spondylolisthess, (3) fracture, (4) spinal deformines (i.e., scoliosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stemosis and/or, (2) spondylolysis.
The purpose of this 510(k) submission is to incorporate additional TSRH®-3D connecting components into the system.
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, and connecting components. In addition, GDLH® rods, DYNALOK PLUSTM bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON® set screws and locking screws may be used with the TSRH® Spinal System.
The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3DG connectors and TSRH-3D® screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used auteriorly as well.
The TSRH® Spinal System components are fabricated from stainless steel conforming to A STM F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, they may be fabricated from medical grade titanium alloy conforming to ASTM F-136 or ISO 5832-3 or medical grade titanium conforming to ASTM F67. The TSRH® Spinal System may be sold sterile or non-sterile.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the TSRH® Spinal System, outlining its description, indications for use, and a declaration of substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, device performance, study design, expert involvement, or ground truth establishment.
The document primarily focuses on:
- Device Description: What the TSRH® Spinal System is and its components.
- Indications for Use: The specific medical conditions for which the device is intended.
- Substantial Equivalence: A statement that the updated components are substantially equivalent to previously marketed versions of the system.
- Regulatory Information: FDA correspondence regarding the 510(k) clearance.
{0}------------------------------------------------
K030285 p 1/2
FEB 2 5 2003
TSRH® Spinal System 510(k) Summary February 2003
- Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: TSRH® Spinal System II.
Regulation Numbers: 888.3050, 888.3060 and 888.3070
Regulation Names: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System, and Pedicle Screw Spinal System.
Codes: NKB, KWP, MNH and MNI
III. Description
The purpose of this 510(k) submission is to incorporate additional TSRH®-3D connecting components into the system.
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, and connecting components. In addition, GDLH® rods, DYNALOK PLUSTM bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON® set screws and locking screws may be used with the TSRH® Spinal System.
The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3DG connectors and TSRH-3D® screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used auteriorly as well.
The TSRH® Spinal System components are fabricated from stainless steel conforming to A STM F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, they may be fabricated from medical grade
{1}------------------------------------------------
titanium alloy conforming to ASTM F-136 or ISO 5832-3 or medical grade titanium conforming to ASTM F67. The TSRH® Spinal System may be sold sterile or non-sterile.
IV. Indications for Use:
When used as a pedicle screw fixation system in 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 discogemic 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 turnor, 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 (LS-S1) 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) degencrative 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) turnor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
For anterior use only the TSRH Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.
- V. The subject TSRHO-3D components were declared substantially equivalent to the predicate TSRH®-3D Spinal System components manufactured by Mediconic Sofamor Danek. Risk analysis and design verification information was provided to support this application.
© 2003 Medtronic Sofamor Danek
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three parallel lines extending from its head, resembling feathers or wings.
FEB 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K030285
Trade/Device Name: TSRH® Spinal System Regulatory Number: 21 CFR 888.3070(b)(2), 888.3070 (b)(1), 888.3050, 888.3060 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: January 27, 2003 Received: January 28, 2003
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 provision's 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
{3}------------------------------------------------
Page 2 - Richard W. Treharne, Ph.D.
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. 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
R. Mark N. Milkman
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
{4}------------------------------------------------
510(k) Number (if known): K030285
TSRH® Spinal System Device Name:_
Indications for Use:
When used as a pedicle screw fixation system in the non-cervical posterior spinc in skeletally manure patients, the TSRH®Spinal System is indicated for one or more of the following: (1) degencrative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic sudies), (2) degenerative spondylolisthesis with objective evidence of neurologic impartment, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, 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 (15-S1) 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 (LS 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) spondylolisthess, (3) fracture, (4) spinal deformines (i.e., scoliosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stemosis and/or, (2) spondylolysis.
(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 Milliken
torative
-1906-
N/A