STAINLESS STEEL SPINAL SYSTEM

K100970 · Theken Spine, LLC · NKB · Aug 12, 2010 · Orthopedic

Device Facts

• Record ID: K100970
• Device Name: STAINLESS STEEL SPINAL SYSTEM
• Applicant: Theken Spine, LLC
• Product Code: NKB · Orthopedic
• Decision Date: Aug 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Stainless Steel Spinal System comprises screws, rods, hooks, and cross-connectors; components lock together to create rigid construct for promoting spinal fusion. Used in surgical settings by physicians; provides mechanical stabilization of spine segments. Benefits patient by facilitating fusion in presence of degenerative disease, trauma, or deformity. Device is purely mechanical; no electronic or software components.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F-1717, including static axial compression, static torsion, and dynamic axial compression. Results confirmed the construct performed as designed and met or exceeded all product specifications.

Technological Characteristics

Construct consists of medical grade stainless steel alloy 316 LVM (ASTM F-138, ISO 5832-1). Mechanical fixation system comprising screws, rods, hooks, and cross-connectors. No energy source, connectivity, or software.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical spinal fixation as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion. Used for posterior pedicle screw (T1-S2/ilium), posterior non-pedicle (T1-L5), or anterolateral (T8-L5) fixation.

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

• Theken Surgical Coral Spinal System (K041592)
• Theken Spine Coral Pedicle Screw System (K070962)
• Theken Spine Modification to Coral Spinal System (K081414)
• IST Pedicle Screw system (K053276)

Submission Summary (Full Text)

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K100970

# 510(k) Summary
(21 CFR Part 807.92)

| A. Submitter Information | |
|-------------------------------|------------------------------------------|
| Submitter's Name: | Theken Spine, LLC |
| Establishment Registration #: | 1530901 |
| Address: | 1800 Triplett Blvd.<br>Akron, Ohio 44306 |
| Telephone Number: | 330-475-8600 |
| Fax Number: | 330-773-7697 |
| Contact Person: | Dale Davison |
| Date Prepared: | 7/28/2010 |

AUG1 2 2010

| B. Device Information | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Stainless Steel Spinal System |
| Common Name: | Screw / Hook and Rod Spinal Instrumentation System |
| Classification: | MNI 888.3070 (Class II) - Orthosis, Spinal Pedicle Fixation<br>MNH 888.3070 (Class II) - Orthosis, Spondylolisthesis Spinal Fixation<br>NKB 888.3070 (Class III) - Orthosis, Spinal Pedicle Fixation, For<br>Degenerative Disc Disease<br>KWP 888.3050 (Class II) - Appliance, Fixation, Spinal Interlaminal<br>KWQ 888.3060 (Class II) - Appliance, Fixation, Spinal Intervertebral<br>Body |
| Predicate Devices: | Theken Surgical Coral Spinal System, K041592<br>Theken Spine Coral Pedicle Screw System, K070962<br>Theken Spine Modification to Coral Spinal System, K081414<br>IST Pedicle Screw system, K053276 |
| Device Description: | The Stainless Steel Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, and cross-connectors. The Stainless Steel Spinal System components can be rigidly locked together creating a rigid construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F-138 and ISO 5832-1. |
| Intended Use: | The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. |
| Technological Characteristics: | The Stainless Steel Spinal System is equivalent to the Coral Spinal System in design and indications for use and substantially equivalent to the predicates listed in terms of design concepts, feature comparisons, indications for use and known biocompatible materials. |

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K100970

#### Summary of Test Data:

Mechanical testing of the subject device consisted of static axial compression, static torsion, and dynamic axial compression. Testing was conducted in accordance with ASTM F-1717. The construct performed as designed and met or exceeded all product specifications.

### C. Substantial Equivalence

Theken Spine believes sufficient evidence exists to reasonably conclude that the indications are substantially equivalent to the predicate device Coral Spinal System (K041592 SE 9/04, K070962 SE 8/07 and K081414 SE 06/08), manufactured by Theken Spine, LLC and the Paramount Pedicle Screw System (K053276 SE 12/05), manufactured by Innovative Spinal Technologies. This is based on the design concept, the use of established, known materials, feature comparisons, indications for use, and engineering analysis.

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

Theken Spine, LLC % Mr. Dale Davison Vice President Engineering 1800 Triplet Boulevard Akron, Ohio, 44306

Re: K100970

Trade/Device Name: Stainless Steel Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: July 28, 2010 Received: July 29, 2010

AUG 1 2 2010

Dear Mr. Davison:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act 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 - Mr. Dale Davison

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Oailare Buehns

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

Enclosure

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## Indications for Use

510(k) Number: K100970

Device Name: Stainless Steel Spinal System

AUG 1 2 2010

Indications for Use:

The Stainless Steel Spinal System is a non-cervical fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (Ti-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use _ X AND/OR

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

X100970 510(k) Number

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