EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM

K111136 · Depuy Spine, Inc. · NKB · Jun 14, 2012 · Orthopedic

Device Facts

• Record ID: K111136
• Device Name: EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Jun 14, 2012
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K111136 · Jun 14, 2012	EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM	Depuy Spine, Inc.	Published clinical literature	Published clinical results were utilized to support the expansion of indications for the EXPEDIUM and VIPER/VIPER2 Spine Systems.	Published clinical results; Expansion of indications

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Published clinical results; Literature review of clinical results	—	Not applicable for this study	Clinical performance/safety for expanded indications

Indications for Use

The EXPEDIUM and VIPER/VIPER2 Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM and VIPER/VIPER2 Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation 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; curvaures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VIPER/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation 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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. The EXPEDIUM and VIPER/VIPER2 PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI-SI in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

Pedicle screw and rod system for spinal stabilization and fusion; includes EXPEDIUM and VIPER/VIPER2 components. Used by surgeons in clinical settings to treat spinal deformities and instabilities. System components (screws, rods, connectors) provide mechanical immobilization of spinal segments. Metallic components (titanium, stainless steel, cobalt-chrome) and PEEK rods implanted via posterior or percutaneous MIS approaches. Device provides structural support to facilitate bone fusion; intended for use with autograft or allograft. No electronic or software components.

Clinical Evidence

No new clinical testing performed. Substantial equivalence supported by published clinical results and engineering analysis.

Technological Characteristics

Pedicle screw spinal system. Materials: Commercially pure titanium/titanium alloy (ASTM F-67, F-136, F-1472), stainless steel (ASTM F-138, F-1314, F-2229), cobalt-nickel-chromium-molybdenum alloy (ASTM F-562), cobalt-chromium-molybdenum alloy (ASTM F-1537), and PEEK. Mechanical fixation components include screws, rods, and connectors. No energy source, software, or connectivity.

Indications for Use

Indicated for skeletally mature patients with acute/chronic spinal instabilities or deformities (thoracic, lumbar, sacral) requiring immobilization/stabilization as adjunct to fusion. Specific conditions: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, failed previous fusion. PEEK rods indicated for spinal stenosis with instability (Grade I spondylolisthesis) L1-S1. Pediatric indication: adolescent idiopathic scoliosis (posterior approach only). Used with autograft/allograft.

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.

Submission Summary (Full Text)

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K111136 - page 1 of 3

## 510(K) SUMMARY

JUN 1 4 2012

| Contact: | Kevin G. Stevens<br>DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767<br>508.828.3288 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | EXPEDIUM® Spine System, VIPER® System, VIPER®2 System |
| Manufacturer: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 |
| Common Name: | Pedicle Screw System |
| Classification: | 21 CFR §888.3050; Spinal interlaminar fixation orthosis<br>21 CFR §888.3060; Spinal intervertebral body fixation orthosis<br>21 CFR §888.3070; Pedicle screw spinal system |
| Class: | III |
| Product Code: | MNI, MNH, NKB, KWQ, KWP, OSH |

. Indications For Use:

The EXPEDIUM and VIPER/VIPER2 Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM and VIPER/VIPER2 Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation 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

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(i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for 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 in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

## Device Description:

The subject EXPEDIUM® Spine System and VIPER®/VIPER®2 Systems are pedicle screw scoliosis systems for the treatment of pediatric patients consisting of a wide range of components in a variety of geometries and sizes.

### Predicate Device(s):

The EXPEDIUM® Spine System and VIPER®/VIPER®2 System were shown to be substantially equivalent to previously cleared predicate devices.

### Performance Data:

No new testing was performed. Published clinical results and engineering analysis supported the expansion of indications.

### Materials:

The subject EXPEDIUM Spine System components have been previously cleared in commercially pure titanium or titanium alloy conforming to ASTM F-67, ASTM F-136 or ASTM F-1472 specifications, stainless steel conforming to ASTM F-138, ASTM F-1314, or F-2229 specifications, cobalt-nickelchromium- molybdenum alloy wire conforming to ASTM F-562 specifications, as well as longitudinal rods in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537.

The subject VIPER/VIPER2 System components have been previously cleared in titanium alloy conforming to ASTM F-136 specifications, stainless steel conforming to ASTM F-138 or ASTM F-1314

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KII 1136 page 3 of 3

specifications, as well as longitudinal rods in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537.

Conclusion:

The substantial equivalence justification demonstrates that the device is as effective, and performs as well as the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background. The overall design is simple and recognizable, representing the department's focus on health and human welfare.

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

June 27, 2013

DePuy Spine, Inc. % Mr. Kevin G. Stevens 325 Paramount Drive Raynham, Massachusetts 02767

Re: K111136

Trade/Device Name: EXPEDIUM Spine System, VIPER System, VIPER2 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: June 08, 2012 Received: June 11, 2012

Dear Mr. Stevens:

This letter corrects our substantially equivalent letter of June 14, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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# Page 2 - Mr. Kevin G. Stevens

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,

Image /page/4/Picture/8 description: The image shows the name "Erin Dreith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif font. The last name, "Dreith," is written in a more decorative font, with the letters overlapping and outlined.

For

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

Enclosure

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EXPEDIUM Spine System and VIPER Systems 510(k)

#### Indications for Use 4.

510(k) Number (if known): K | | | 36

Device Name: EXPEDIUM® Spine System, VIPER® System, VIPER®2 System

The EXPEDIUM and VIPER/VIPER2 Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM and VIPER/VIPER2 Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation 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; curvaures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation 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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The EXPEDIUM and VIPER/VIPER2 PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI-SI in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Prescription Use V AND/OR (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)

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

KITI 36 510(k) Number_