When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, 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 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 using bone graft: (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)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, pseudarthritis; and/or failed previous fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

Device Description

The purpose of this Special 510(k) is to add the subject devices which consist of bone screws, set screws, and connectors to the TSRH® Spinal 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, 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 These components include GDLH® rods, GDLH® rod/bolt TSRH® Spinal System. connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, bolts, CD HORIZON® MULTI-SPAN® DYNALOK® PLUSTM Low Profile 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.

The TSRH® Spinal System components are fabricated from medical grade stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The subject components will be manufactured from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or ISO 5832-2. The TSRH® Spinal System may be sold sterile or non-sterile.

AI/ML Overview

This 510(k) summary for the TSRH® Spinal System describes adding new components (bone screws, set screws, and connectors) to an existing system. The primary method for demonstrating substantial equivalence is through mechanical test results and comparison to predicate devices, rather than a clinical study involving human or algorithmic performance. Therefore, many of the requested categories related to clinical study design and AI performance are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description from Document
Mechanical Performance	Substantially equivalent mechanical test results for bone screws, set screws, and connectors compared to predicate devices.
Material Composition	Fabricated from medical grade stainless steel, titanium alloy (ASTM F67 or ASTM F136), or titanium (ISO 5832-3 or ISO 5832-2).
Indications for Use	Identical to those cleared in K052054 (bone screws) and K072317 (set screws and connectors). This implies the new components maintain the same intended uses and safety profiles as the predicate devices.
Labeling	Identical to that cleared in K052054 (bone screws) and K072317 (set screws and connectors).
Sterility	May be sold sterile or non-sterile.

Reported Device Performance: The document states that "Mechanical test results were provided in support of this submission." The conclusion is that the new components "were demonstrated to be substantially equivalent" to the predicate devices in terms of mechanical performance and other characteristics. Specific quantitative performance metrics (e.g., maximum load, fatigue cycles) are not detailed in this summary but would have been part of the full 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance

This submission relies on mechanical testing of the device components, not a clinical test set with patient data. Therefore:

Sample Size for Test Set: Not applicable in the context of clinical data. The sample size would refer to the number of devices or components tested in the mechanical studies. This information is not provided in the summary.
Data Provenance: Not applicable in the context of clinical data. The data originates from laboratory mechanical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth in this context would refer to the established mechanical specifications and performance standards for spinal fixation devices, which are defined by regulatory bodies and consensus standards, not by individual clinical experts in a test set.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for human interpretation of clinical data. This submission is based on mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance (with or without AI assistance) on clinical cases and is not relevant for a device submission focused on mechanical equivalence of new components to an existing spinal system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on established mechanical performance standards and specifications for spinal fixation devices, as demonstrated through laboratory testing and comparison to legally marketed predicate devices. This is a technical/engineering ground truth rather than a clinical ground truth like pathology or expert consensus on patient outcomes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a mechanical device submission demonstrating substantial equivalence. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as above.

Summary

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K090740
Page 1 of 3

AUG 1 4 2009

TSRH® Spinal System 510(k) Summary March 2009

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

Lila Joe Contact: Regulatory Affairs Specialist

II. Proposed Proprietary Trade Name: TSRH® Spinal System

III, Classification Names

Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System, and Pedicle Screw Spinal System. Class: II, III Product Code(s): KWP, MNI, MNH, NKB Regulation No.: 888.3050, 888.3060, 888.3070

IV. Description

The purpose of this Special 510(k) is to add the subject devices which consist of bone screws, set screws, and connectors to the TSRH® Spinal 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.

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CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, set screws and locking screws.

V. Indications for Use:

fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

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(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 indication of: spondylolysis.

IV. Substantial Equivalence:

The subject components (bone screws, set screws and connectors) were demonstrated to be substantially equivalent to TSRH® Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K021170 (S.E. 07/16/2002), K 022778 (S.E. 09/18/2002), and K052054 (S.E. 08/19/05) for the bone screws, and K072317 (S.E. 09/28/2007) for the set screws and connectors. Mechanical test results were provided in support of this submission. The labeling for this device is identical to that cleared by the agency in K052054 for the bone screws and K072317 for the set screws and connectors.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Sofmaor Danek % Ms. Lila Joc Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

AUG 1 4 2009

Re: K090740

Trade/Device Name: TRSH® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: July 15, 2009 Received: July 16, 2009

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.

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 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.

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Page 2 - Ms. Lila Joe

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/CDRH/CDRHOffices/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.

Sincerely yours,

Mark N. Me kerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 长090740

TSRH® Spinal System Device Name:

Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, 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 sketaily mature patients using bone graft: (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 (13 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: { } 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.

For anterior use only the TSRH® System has the additional indication of: spondylolysis.

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

Over-the-counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

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