XIA 3 SPINAL SYSTEM

K113666 · Stryker Spine · NKB · Aug 28, 2012 · Orthopedic

Device Facts

• Record ID: K113666
• Device Name: XIA 3 SPINAL SYSTEM
• Applicant: Stryker Spine
• Product Code: NKB · Orthopedic
• Decision Date: Aug 28, 2012
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fustion using autograft 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) ﻢ - -Tumor; - Pseudoarthrosis; and . - Failed previous fusion . The 05.5mm rods from the Stryker Spine Radius™ Spinal System and 06.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System. When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® 3 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

Noncervical pedicle screw system; includes monoaxial/polyaxial bone screws, rods, hooks, connectors. Used by surgeons in spinal fusion procedures to provide structural support/stabilization. Implants secured to spine to facilitate fusion with autograft/allograft. Benefits include correction of spinal deformities and stabilization of unstable segments.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing (static/dynamic compression bending, static torsion, interconnection strength) and clinical literature analysis.

Technological Characteristics

Materials: Ti6Al4V alloy, CP Ti, CoCrMo alloy (Vitallium). Mechanical testing per ASTM F1717-04 and ASTM F1798-97. Components: monoaxial/polyaxial screws, rods, hooks, connectors.

Indications for Use

Indicated for skeletally mature patients with noncervical spine instabilities/deformities (DDD, spondylolisthesis, trauma, stenosis, scoliosis/kyphosis/lordosis, tumor, pseudoarthrosis, failed fusion) and pediatric patients with adolescent idiopathic scoliosis (posterior approach only).

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

• Synthes Spine USS Small Stature System (K994121)
• Stryker Spine XIA® 3 Spinal System (K071373)
• Paradigm Spine Orthobiom Spinal System (K071668)
• Medtronic Sofamor Danek USA CD HORIZON Spinal System (K091445)
• Medtronic Sofamor Danek TSRH Spinal System (K111492)

Submission Summary (Full Text)

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## KIJ3666

Page 1 of 3

AUG 2.8 , 2012

## 510(k) Summary

## Applicant:

# Stryker Spine

2 Pearl Court, Allendale, NJ 07401

Phone: [phone] / Fax: [phone]

E-mail: [e-mail]

Contact Information:

Tiffani Rogers, Regulatory Affairs Manager Stryker Spine 2 Pearl Court, Allendale, NJ 07401

Phone: [phone]/ Fax: [phone]

E-mail: [e-mail]

Device Trade Name:

XIA® 3 Spinal System

Manufacturer:

Stryker Spine

Zone Industrielle Demarticot

Cestas, France 33610

Phone: + 33 577 97 08 40

Manufacturer Establishment Number: 9617544

and

Stryker Spine

Le Cret Du Locle 10a

La Chaux De Fonds

Switzerland 2300

Establishment Registration Number: 3005525032

## Date Prepared:

August 22, 2012 ·

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# KI13666 Page 2 of 3

| Classification/ | 21 CFR§888.3070 (b) (1) & (b) (2) / Pedicle Screw Spinal System |
|----------------------|-----------------------------------------------------------------|
| Classification Name: | 21 CFR§888.3050 / Spinal Interlaminal fixation orthosis |
| | |
| Classification: | III / II |
| | |
| Product Code: | OSH, MNH, MNI, KWP, NKB |
| | |

#### Indication for Use:

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fustion using autograft in skeletally mature patients in 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);
- . Spondy lolisthesis;
- Trauma (i.e. fracture or dislocation); -
- Spinal stenosis: -
- . Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor; •
- Pseudoarthrosis; and
- Failed previous fusion .

The Ø5.5mm rods from the Stryker Spinal System and Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System."

When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® 3 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

#### Device Description:

The Stryker Spine XIA® 3 Spinal System is a noncervical pedicle screw system comprised of monoaxial and polyaxial bone screws, blocking mechanism), rods, hooks, and connectors. The implants are manufactured from Ti6Al4V alloy, CP Ti, and CoCrMo alloy (Vitallium).

The expansion of indications for the XIA® 3 Spinal System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediatic population. As pediatric patients are unlikely to exhibit symptoms of degenerative disc disease (DDD) or stenosis due to the wear and tear on the spine necessary to develop these diseases, expansion of these indications to a pediatric population is not warranted.

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# KI13666 Page 3 of 3

#### Predicate Devices:

- Synthes Spine USS Small Stature System, K994121 .
- Stryker Spine XIA® 3 Spinal System, K071373 .
- . Paradigm Spine Orthobiom Spinal System, K071668
- Medtronic Sofamor Danek USA CD HORIZON Spinal System, K091445 .
- Medtronic Sofamor Danek TSRH Spinal System, K111492 t

#### Substantial Equivalence:

Testing performed on XIA® 3 Spinal System indicates that the system is substantially equivalent to predicate devices. Mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717-04 and interconnection strength testing per ASTM F1798-97, as well as, a clinical literature analysis.

The XIA® 3 Spinal System substantial equivalence determination to the predicate systems is based on dimensional comparisons and engineering analyses in addition to preclinical testing.

#### Conclusion:

The XIA® 3 Spinal System was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.

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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 its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

June 27, 2013

Stryker Spine % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Glenn Stiegman 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K113666 Trade/Device Name: Xia® 3 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, OSH, KWP, MNH, MNI Dated: July 25, 2012

Received: August 1, 2012

Dear Mr. Stiegman:

This letter corrects our substantially equivalent letter of August 28, 2012.

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. Glenn Stiegman

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.

# Erin DKeith

For

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

Enclosure

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Stryker Spine XIA® 3 Spinal System Traditional 510(k)

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K113666

Device Name: XIA® 3 Spinal System

Indications for Use:

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fustion using autograft 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) ﻢ
- -Tumor;
- Pseudoarthrosis; and .
- Failed previous fusion -

The 05.5mm rods from the Stryker Spine Radius™ Spinal System and 06.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System.

When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® 3 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis.

The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D)

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) | |
|--------------------------------------------------------|--|
| Christy Foumer | |
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, | |

and Restorative Devices

510(k) Number K113666