(53 days)
Not Found
No
The document describes a mechanical spinal fixation system composed of rods, hooks, screws, and other components. There is no mention of software, algorithms, image processing, or any other technology that would suggest the use of AI or ML. The performance studies described are mechanical tests.
Yes
Explanation: The device is a spinal system (rods, hooks, screws, etc.) used as an adjunct to fusion for various spinal conditions such as degenerative disc disease, scoliosis, kyphosis, fractures, and tumors, which are all therapeutic purposes.
No
Explanation: The provided text describes the TSRH® Spinal System as a surgical fixation system consisting of various implants (rods, screws, hooks, etc.) used as an adjunct to fusion for treating spinal conditions. It does not mention any diagnostic capabilities or functions.
No
The device description clearly states it consists of physical components like rods, hooks, screws, plates, etc., fabricated from medical-grade materials. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant system for spinal fixation. It is used in the body to provide structural support and aid in fusion.
- Device Description: The device description details physical components like rods, hooks, screws, plates, etc., which are all hardware intended for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a surgical implant, not a diagnostic tool used outside the body on biological samples.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH® Spinal System is indicated as an adjunct to fusion 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 as an adjunct to fusion for skeletally mature patients using allograft and/or autograft: (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, 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® System has the additional indication of: spondylolysis.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH® Pediatric Spinal System is intended to be used with allograft. Pediatric pedicle sorew fixation is limited to a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, KWP, MNI, MNH, NKB, OSH
Device Description
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.
A subset of TSRH® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use such as Low Profile MULTI-SPAN® CROSSLINK® Plates, and CD HORIZON® rods, screws, set screws and locking screws. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used In pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy and medical grade cobalt -chromiummolybdenum alloy.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System in non-pediatric components. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and VANTAGE™ Anterior Fixation System screws.
The hooks are Intended for posterior use only. 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. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System Implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy with stainless steel in the same construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, non-cervical posterior spine, fifth lumbar-first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 and below), antero-lateral thoracic/lumbar region
Indicated Patient Age Range
Skeletally mature patients, pediatric patients, adolescent idiopathic scoliosis
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)
Sublect Device: TSRH® 3Dx Chromalov Plus Straight 5,5mm Diameter Rod The test performed per ASTM F1798-97 (2008). "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." (approved 2003) was axlal grip around the rod.
The test performed per ASTM F2193 (2002). "Standard Specifications and Test Methods fro Components Used in the Surgical Fixation of the Spinal Skeletal System." (approved June 2002) was four point fatigue testing.
Medtronic believes that the results of the testing performed above and supporting documentation provided in this Special 510(k) submission demonstrate that the subject TSRH® 3Dx Chromaloy Plus 5.5mm diameter x 500mm long rod does not introduce new issues of safety, effectiveness, or performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K111'942
TSRH® Spinal System 510(k) Summary
August 4, 2011
AUG 3 0 2011
Company: l. Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
| Contact: | Lila Joe
Prin. Regulatory Affairs Specialist |
| ---------- | ------------------------------------------------- |
|---|
(1. 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, respectively); Product Code(s): KWQ, KWP, MNI, MNH, NKB, OSH
IV. Description:
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.
A subset of TSRH® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use such as Low Profile MULTI-SPAN® CROSSLINK® Plates, and CD HORIZON® rods, screws, set screws and locking screws. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used In pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy and medical grade cobalt -chromiummolybdenum alloy.
1
TSRH® Spinal System staples, unit rods, s-rods and 7:0 mm diameter rods are specifically excluded for use in pediatric patients.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System in non-pediatric components. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and VANTAGE™ Anterior Fixation System screws.
The hooks are Intended for posterior use only. 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. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System Implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy with stainless steel in the same construct.
No warranties, express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warrantles and limitations of liability.
To achieve best results, do not use any of the TSRH® Spinal System Implant components with components from any other system, except those components listed above, or any other manufacturer. As with all orthopaedic and neurosurgical implants, none of the TSRH® Spinal System components should ever be reused under any circumstances.
V. Indications for Use:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH®Spinal System is Indicated as an adjunct to fusion 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) disiocation, (5) scollosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudanthrosis).
2
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated as an adjunct to fusion for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-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 solld 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 deformitles (1.e., scollosis, 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: spondylollsthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scollosis, kyphosis and/or lordosis); tumor; pseudarthrosls; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idlopathic scollosis. The TSRH® Pedlatric Spinal System Is Intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
VI. Summary of the Technological Characteristics
The purpose of this Special 510(k) submission is to include a 5.5mm diameter rod that is 500mm long and manufactured from ASTM F1537 Wrought Cobalt-28Chromium-6Molybdenum Alloy that is single annealed.
The legally marketed predicate is the CD HORIZON® Chromaloy 5.5mm dlameter x 500mm long rod cleared to be used with the TSRH® Spinal System by the Agency in the K093058 (S.E. 10/28/2009) and the TSRH® Chromaloy+ Precut Contoured 5.5mm Diameter Rods In lengths from 30mm - 120mm cleared in K103049 (S.E. 12/23/2010).
3
The table below lists the differences between the predicate devices and the subject device.
| Predicate
CD HORIZON Spinal System
(K093058) | Predicate
TSRH® Spinal System
(K103049) | Subject
TSRH® Spinal System
Rod |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Material
Wrought Cobalt -
28Chromium - 6Molybdenum,
Double Annealed
(ASTM F1537) | Wrought Cobalt -
28Chromium - 6Molybdenum,
Single Annealed
(ASTM F1537) | Wrought Cobalt -
28Chromium - 6Molybdenum,
Single Annealed
(ASTM F1537) |
| Length
500mm | 30mm - 120mm | 500mm |
| Diameter
5.5mm | Identical | Identical |
| Shape
Straight | Contoured | Straight |
| Fundamental Scientific
Technology
(Rod and Screw System) | Identical | Identical |
VII. Identification of Legally Marketed Devices
Documentation was provided demonstrating that the TSRH® Spinal System is substantlally equivalent to other commercially available fixation systems Including the TSRH® Spinal System in K093058 (S.E. 10/28/2009), K103049 (S.E. 12/23/2010), and K110070 (S.E. 6/8/2011).
VIB. Discussion of the Non-Cilnical Testing
Sublect Device: TSRH® 3Dx Chromalov Plus Straight 5,5mm Diameter Rod The test performed per ASTM F1798-97 (2008). "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." (approved 2003) was axlal grip around the rod.
The test performed per ASTM F2193 (2002). "Standard Specifications and Test Methods fro Components Used in the Surgical Fixation of the Spinal Skeletal System." (approved June 2002) was four point fatigue testing.
Medtronic believes that the results of the testing performed above and supporting documentation provided in this Special 510(k) submission demonstrate that the subject TSRH® 3Dx Chromaloy Plus 5.5mm diameter x 500mm long rod does not introduce new issues of safety, effectiveness, or performance.
4
IX. Conclusion
The TSRH® 3Dx CHROMALOY™ + Straight 5.5mm Diameter Rod is Identical to its predicate devices in the indications, material, diameter, sterllization, surgical technique, and fundamental scientific technology. Additionally, a risk analysis was completed and nonclinical mechanical testing was performed in accordance to ASTM F1798-97 and ASTM F2193 that demonstrates the subject device does not introduce new issues of safety, effectiveness, or performance. Therefore, the subject device is substantially equivalent to its predicate devices.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2013
Medtronic Sofamor Danek USA, Inc. % Ms. Lila Joe Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K111942
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, OSH, MNI, MNH, KWP, KWQ Dated: August 04, 2011 Received: August 05, 2011
Dear Ms. Joe:
This letter corrects our substantially equivalent letter of August 30, 2011.
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. Iisting 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 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
6
Page 2 - Ms. Lila Joe
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/6/Picture/6 description: The image shows the name "Erin Dkeith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif font. The last name, "Dkeith," is written in a more decorative font, with some of the letters overlapping and some of the lines being thicker than others.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known):
Device Name: TSRH® Spinal System
Indications for Use:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH® Spinal System is indicated as an adjunct to fusion 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 as an adjunct to fusion for skeletally mature patients using allograft and/or autograft: (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) spondylollsthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, 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® System has the additional indication of: spondylolysis.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH® Pediatric Spinal System is intended to be used with allograft. Pediatric pedicle sorew fixation is limited to a posterior approach.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (21CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-OfD
PaLof
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices