ES2 SPINAL SYSTEM MODEL 48280XXXX

K122845 · Stryker Spine · NKB · Dec 7, 2012 · Orthopedic

Device Facts

• Record ID: K122845
• Device Name: ES2 SPINAL SYSTEM MODEL 48280XXXX
• Applicant: Stryker Spine
• Product Code: NKB · Orthopedic
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ES2™ Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture or dislocation), Spinal stenosis, Curvatures (i.e. scoliosis, kyphosis, and/or lordosis), Tumor, Pseudoarthrosis, and Failed previous fusion.

Device Story

ES2 Spinal System is a line extension of the MANTIS Redux Spinal System; features integrated retractor blades on the removable tab portion of the pedicle screw head. System facilitates percutaneous, posterior, non-cervical spinal fixation. Used in conjunction with powered instrumentation (Stryker CD3 Cordless Driver 3, RemB Universal Driver) via a Power Adaptor to rotate screwdrivers for pedicle screw insertion. Operates in clinical settings by surgeons to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Titanium and Vitallium rods from the RADIUS system are compatible. Output is the mechanical stabilization of the spine; assists surgeons in achieving spinal fusion; benefits patients by stabilizing spinal segments in the presence of degenerative disease, trauma, or deformity.

Clinical Evidence

Bench testing only. Engineering analysis and mechanical testing were performed to demonstrate compliance with FDA's Guidance for Spinal System 510(k)s.

Technological Characteristics

Spinal fixation system consisting of pedicle screws and rods. Materials include Titanium and Vitallium. Features integrated retractor blades on screw head tabs. Compatible with powered instrumentation (corded/cordless drivers). Mechanical stabilization principle. Non-sterile/sterile (implied by standard orthopedic practice).

Indications for Use

Indicated for skeletally mature patients requiring non-cervical, posterior, percutaneous pedicle and non-pedicle fixation as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

• MANTIS Redux Spinal System (K092631)
• K102235

Reference Devices

• Stryker Spine RADIUS Spinal System
• Xia Spinal Systems (Xia Stainless Steel, Xia II, Xia Anterior, Xia Precision)
• Xia 3 Spinal System
• Xia 4.5 Spinal System
• MANTIS Spinal System

Submission Summary (Full Text)

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## K122845

## ES2™ Spinal System - Line Extension of MANTIS® & MANTIS® Redux

## Page 1 of 3

## Special 510(k) Premarket Notification

## Special 510(k) Summary: ES2"31 Spinal System - Line Extension of MANTIS® & MANTIS® Redux

DEC 7 2012

Proprietary Name: Common Name:

ES2™ Spinal System Spinal Fixation Appliances

Classification Name and Reference:

Device Product Code: -Proposed Regulatory Class: For Information contact:

Date Summary Prepared: Predicate Devices

Description of Device Modification

Indication for Use

1) Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060 2) Pedicle Screw Spinal System, 21 CFR §S88.3070 (b) (1) & (b) (2) NKB, MNH, MNI. KWQ. Class III Soraya King Regulatory Affairs Specialist 2 Pearl Court Allendale, NJ 07401 Telephone: [phone] Fax: [phone] Email: [e-mail] December 6, 2012 Stryker Spine MANTIS® Redux Spinal System, K092631 and な

K102235

This 510(k) is intended to introduce an extension to the existing MANTIS® Redux Spinal System. The proposed line extension pertains to the integration of the retractor blades to the removable Tab portion of screw head. The MANTIS® Redux Spinal System with the integrated blades will also be rebranded as the ES2TM Spinal System. This submission also seeks clearance of the ES2™ Spinal System with the powered accessory instruments cleared through 510(k) submissions K111478 and K120434

The ES2TM Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally

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Special 510(k) Premarket Notification

ES273 Spinal System - Line Extension of MANTIS® & MANTIS® Redux

mature patients as an adjunct to fusion for the following indications:

- Degenerative Disease (defined as back pain of discogenic . origin with degeneration of the disc confirmed by history and radiographic studies),
- 0 Spondylolisthesis.
- Trauma (i.e. fracture or dislocation), �
- Spinal stenosis. �
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis), o
- Tumor. な
- Pseudoarthrosis, and o
- o Failed previous fusion.

The Titanium and Vitallium® rods from the Stryker Spine RADIUS® Spinal System are also intended to be used with other components of the MANTIS® Spinal System, MANTIS® Redux Spinal Systems and ES27M Spinal System.

## Intended Use:

To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia Spinal Systems (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and MANTIS® Spinal System, MANTIS® Redux Spinal System and the ES2TM Spinal System.

## Indications for Use:

The Xia Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and

Indication & Intended Use with Powered Instruments

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#### ES2TN Spinal System - Line Extension of MANTIS® & MANTIS® Redux

### Page 3 of 3

radiographic studies); spondylolisthesis; trauma; (i.e. fracture or dislocation): spinal stenosis; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pscudoarthrosis; and failed previous fusion.

The XIA 4.5. Xia 3. Radius Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3. XIA 4.5. Xia 3. and Radius Spinal Systems are intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The MANTIS® Spinal System, MANTIS® Redux Spinal System and ES2"N Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; Pseudoarthrosis; and failed previous fusion.

The Stryker Spine ES2131 Spinal Systems, with the incorporation of the subject components, is substantially equivalent to the predicate devices in terms of material, design, and indications for use. Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems.

Summary of the Technological Characteristics

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: December 7, 2012

Stryker Spine % Ms. Soraya King Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K122845

Trade/Device Name: ES2TM Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP Dated: November 14, 2012 Received: November 15, 2012

Dear Ms. King:

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 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

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## Page 2 - Ms. Soraya King

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

Sincerely yours.

# Mark N. Melkerson

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

Enclosure

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Page 1 of 2

## Indications for Use

510(k) Number (if known): K122845

Device Name: ES2TM Spinal System

Indications for Use:

The ES2TM Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

- Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis,
- Trauma (i.e. fracture or dislocation),
- Spinal stenosis,
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis),
- Tumor.
- Pseudoarthrosis, and
- Failed previous fusion.

The Titanium and Vitallium rods from the Stryker Spine RADIUS®, MANTIS® and MANTIS® Redux Spinal Systems are intended to be used with the other components of the ES2TM Spinal System.

Prescription Use X AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122845

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ___K122845

## Device Name: Power Adaptor Instrument Accessory

#### Intended Use:

To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Research 10 lacmate the peachell of peacher of peache seen the the Stryker Instruments Hudson Modified Trinkle Reamer Spile Fower Adaptor is michael to exclusive and the Stryker Instruments RemB Universal Driver. When the and the Strates are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature non-cervical reduce solows from soleer on new spins inipatrumentation. The systems included are the family of Xia Spinal Systems (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Systems (Tha Samess Stech, Ala Hilerior, and Friday Redux Spinal System and the ES2™ Spinal System.

#### Indications for Use:

The Xia Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle The Ala Sphial Jysten 15 micheed 16. and inct to fusion for the following indications: degenerative disc disease IIXation in skelally hature parcens as an againer on the disc confirmed by history and (DDD) (denned as back pan of elsoogenie area. It en fracture or dislocation); spinal stenosis; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA 4.5, Xia 3, Radius Spinal Systems are intended for use in the non-cervical spine. 9 VIA 4 6 Vic 3 THE ATA 4.5, Ata 3, Kianas Spinal Dysterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3, XIA 4.5, Xia 3, and Radius Spinal Systems are intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed degelierative unsease (DDD) (demied as back pain of envant (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scollosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The MANTIS® Spinal System, MANTIS® Redux Spinal System and ES2™ Spinal System is niterned for The MANTIS® Spillar System, WANTHOW Technological Systems of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by degenerative disc unsease (demic as back pair is unsergent or dislocation); spinal stenosis; curvatures mistory and fadiographie additory opsis); tumor; Pseudoarthrosis; and failed previous fusion.

Use Prescription (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122845