Expedium Spine System, VIPER and VIPER 2 Systems

K160904 · Medos International SARL · NKB · Jul 1, 2016 · Orthopedic

Device Facts

• Record ID: K160904
• Device Name: Expedium Spine System, VIPER and VIPER 2 Systems
• Applicant: Medos International SARL
• Product Code: NKB · Orthopedic
• Decision Date: Jul 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The EXPEDIUM Spine System and VIPER and VIPER 2 Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM Spine System and VIPER 2 Systems 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. When used in a posterior percutaneous approach with MIS instrumentation, the VIPER and VIPER 2 Systems are intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); 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. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System and VIPER and VIPER 2 Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System and VIPER 2 Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

Metallic spinal implant system; includes longitudinal rods, monoaxial/polyaxial/uniplanar/reduction screws, hooks, connectors, and washers. Used for immobilization/stabilization of thoracic, lumbar, and sacral spine segments. Implanted by surgeons via open or posterior percutaneous MIS approach. Provides structural support to spinal column; facilitates fusion when used with autograft/allograft. Benefits include correction of deformities and stabilization of unstable segments. System components are modular; allow for customized construct assembly based on patient anatomy and pathology.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1717. Literature review and optical/visual analysis conducted to evaluate corrosion susceptibility of mixed metal constructs (stainless steel and titanium alloys).

Technological Characteristics

Metallic spinal implants. Materials: Commercially pure titanium (ASTM F-67), titanium alloy (ASTM 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). Components: rods, screws (monoaxial, polyaxial, uniplanar, reduction, cable/wire), hooks, connectors, washers. Modular assembly. Non-powered.

Indications for Use

Indicated for skeletally mature patients with chronic spinal instabilities/deformities (thoracic, lumbar, sacral) requiring immobilization/stabilization as adjunct to fusion. Specific indications: degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, scoliosis/lordosis, tumor, pseudoarthrosis, failed previous fusion. Also indicated for pediatric patients (adolescent idiopathic scoliosis) via posterior approach. 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.

Predicate Devices

• EXPEDIUM Spine System and VIPER and VIPER 2 Systems (K111136)

Reference Devices

• EXPEDIUM Spine System, VIPER and VIPER2 Systems (K131802)
• EXPEDIUM Spine System (K130877)
• VIPER System (K121020)
• EXPEDIUM and VIPER Systems (K110216)
• Moss Miami and Expedium Spine Systems (K103490)

Submission Summary (Full Text)

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

July 1, 2016

Medos International SARL % Mr. Mitch Ohiwa Associate Director, Regulatory Affairs DePuy Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767

Re: K160904

Trade/Device Name: EXPEDIUM Spine System, VIPER and VIPER 2 Systems 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: May 11, 2016 Received: May 13, 2016

Dear Mr. Ohiwa:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education 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 -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K160904

#### Device Name

EXPEDIUM Spine System, VIPER and VIPER 2 Systems

#### Indications for Use (Describe)

The EXPEDIUM Spine System and VIPER and VIPER 2 Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System and VIPER 2 Systems 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.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER and VIPER 2 Systems are intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); 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.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System and VIPER and VIPER 2 Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System and VIPER 2 Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <div> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## K160904

## 510(K) SUMMARY – EXPEDIUM Spine System; VIPER and VIPER 2 Systems

## A. Submitter Information

| Manufacturer: | Medos International SARL<br>Chemin-Blanc 38<br>2400 Le Locle, Switzerland |
|-------------------|-------------------------------------------------------------------------------------------|
| Submitter: | DePuy Synthes Spine<br>325 Paramount Drive<br>Raynham, Massachusetts 02767 |
| Contact Person: | Mitch Ohiwa<br>DePuy Synthes Spine<br>325 Paramount Drive<br>Raynham, Massachusetts 02767 |
| Telephone Number: | 508-828-3225 |
| Fax Number: | 508-828-3267 |
| E-mail: | [e-mail] |

## B. Date Prepared

## C. Device Name

| Trade/Proprietary Name: | EXPEDIUM Spine System<br>VIPER and VIPER 2 Systems |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Orthosis, Spinal Pedicle Fixation,<br>For Degenerative Disc Disease |
| Device Classification and Regulation: | Class III; 21 CFR 888.3070; Pedicle Screw Spinal<br>System<br>Class II; 21 CFR 888.3060; Spinal Intervertebral Body<br>Fixation Orthosis<br>Class II; 21 CFR 888.3050; Spinal Interlaminal Fixation<br>Orthosis |

May 11, 2016

Classification Product and Panel Code: NKB, OSH, MNI, MNH, KWP, KWQ; Orthopedic

## D. Prior Formal Correspondence

Pre-submission Q151277

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## E. Predicate Device Name

| Primary Predicate: | EXPEDIUM Spine System and VIPER and VIPER 2 Systems (K111136) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Predicates: | EXPEDIUM Spine System, VIPER and VIPER2 Systems (K131802)<br>EXPEDIUM Spine System (K130877)<br>VIPER System (K121020)<br>EXPEDIUM and VIPER Systems (K110216)<br>Moss Miami and Expedium Spine Systems (K103490) |

### F. Device Description

The EXPEDIUM and VIPER/VIPER 2 Spine Systems are metallic implants intended to provide immobilization and stabilization of spinal segments. They can be used for 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; or for posterior non-cervical pedicle screw fixation in pediatric patients 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.

The EXPEDIUM Spine System consists of longitudinal rods, monoaxial screws, polyaxial screws, uniplanar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers. The VIPER and VIPER 2 Systems consist of cannulated polyaxial screws, monoaxial screws, uni-planar screws, reduction screws, and rods used in a percutaneous approach.

### G. Indications for Use

The EXPEDIUM and VIPER and VIPER 2 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 Spine System and VIPER and VIPER 2 Systems 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 radios); 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 in a posterior percutaneous approach with MIS instrumentation, the VIPER and VIPER 2 Systems 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, kyphosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System and VIPER and VIPER 2 Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System and VIPER 2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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## H. Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use

The technological characteristics, performance, and intended use of the subject devices remain unchanged from the currently marketed predicate devices.

## I. Materials

The materials of the subject devices remain unchanged from the currently marketed predicate devices.

The EXPEDIUM Spine System components are available 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-nickel-chromium-molybdenum alloy wire conforming to ASTM F-562 specifications; as well as longitudinal rods in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537 specifications.

The VIPER and VIPER2 System components are available in titanium alloy conforming to ASTM F-136 specifications; stainless steel conforming to ASTM F-138 or ASTM F-1314 specifications; as well as longitudinal rods in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537.

## J. Performance Data

A review of literature, mechanical testing referencing ASTM F1717, and optical/visual analysis of suspected corrosion demonstrated that stainless steel and titanium alloys and commercially pure titanium) can be compatible even under an aggressive environment for corrosion susceptibility for a duration expected to be necessary for spinal fusion.

### K. Conclusion

The titanium and stainless steel components used in the subject spinal system are substantially equivalent to the predicate devices.