TSRH SPINAL SYSTEMS

K111942 · Medtronic Sofamor Danek USA, Inc. · NKB · Aug 30, 2011 · Orthopedic

Device Facts

• Record ID: K111942
• Device Name: TSRH SPINAL SYSTEMS
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Aug 30, 2011
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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 screw fixation is limited to a posterior approach.

Device Story

TSRH® Spinal System is a modular orthopedic implant system comprising rods, hooks, screws, cross connectors, staples, and plates. Designed for rigid fixation of the non-cervical spine to facilitate fusion. Components are tailor-made for individual cases by surgeons in an operating room setting. System inputs include patient-specific anatomical requirements; outputs are stabilized spinal constructs. Materials include medical-grade stainless steel, titanium alloy, and cobalt-chromium-molybdenum alloy. Certain components may be hydroxyapatite-coated. The device is used by surgeons to treat spinal deformities, fractures, and degenerative conditions. Benefits include spinal stabilization and support for bone fusion. The subject of this submission is a 5.5mm diameter, 500mm long straight rod made of single-annealed cobalt-chromium-molybdenum alloy.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1798-97 (static and fatigue properties of interconnection mechanisms) and ASTM F2193 (components for surgical fixation of the spinal skeletal system).

Technological Characteristics

Materials: ASTM F1537 Wrought Cobalt-28Chromium-6Molybdenum alloy (single annealed). Components: rods, hooks, screws, cross connectors, staples, plates. Energy source: N/A (mechanical). Connectivity: N/A. Sterilization: Not specified. Form factor: 5.5mm diameter, 500mm length straight rod.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, spinal stenosis, or spondylolysis; also indicated for pediatric patients with adolescent idiopathic scoliosis via posterior approach.

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.

Predicate Devices

• CD HORIZON® Spinal System (K093058)
• TSRH® Spinal System (K103049)

Reference Devices

• TSRH® Spinal System (K110070)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

| Contact: | Lila Joe<br>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.

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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).

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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).

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K111942

The table below lists the differences between the predicate devices and the subject device.

| Predicate<br>CD HORIZON Spinal System<br>(K093058) | Predicate<br>TSRH® Spinal System<br>(K103049) | Subject<br>TSRH® Spinal System<br>Rod |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Material<br>Wrought Cobalt -<br>28Chromium - 6Molybdenum,<br>Double Annealed<br>(ASTM F1537) | Wrought Cobalt -<br>28Chromium - 6Molybdenum,<br>Single Annealed<br>(ASTM F1537) | Wrought Cobalt -<br>28Chromium - 6Molybdenum,<br>Single Annealed<br>(ASTM F1537) |
| Length<br>500mm | 30mm - 120mm | 500mm |
| Diameter<br>5.5mm | Identical | Identical |
| Shape<br>Straight | Contoured | Straight |
| Fundamental Scientific<br>Technology<br>(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.

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K111942

### 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.

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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

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# 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K111942

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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