MOSS VRS Spinal System

K181821 · Biedermann Motech GmbH & Co. KG · NKB · Sep 13, 2018 · Orthopedic

Device Facts

• Record ID: K181821
• Device Name: MOSS VRS Spinal System
• Applicant: Biedermann Motech GmbH & Co. KG
• Product Code: NKB · Orthopedic
• Decision Date: Sep 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: - 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. fractures or dislocations) - Spinal Stenosis - Curvatures (i.e. scoliosis, kyphosis and/ or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS system is indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The MOSS VRS system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

MOSS VRS Spinal System is a posterior thoracolumbosacral pedicle screw fixation system; provides spinal segment immobilization and stabilization as an adjunct to fusion. System comprises pedicle screws, rods, locking caps, and polyaxial reduction heads. Used by surgeons in clinical settings to treat mechanical instability or deformity. Implants are single-use; provided non-sterile. Surgeon selects and assembles components to fit patient anatomy; provides rigid construct to support fusion process. Benefits patient by stabilizing spine, correcting deformity, and facilitating bone fusion.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Implants manufactured from titanium alloy (ASTM F136) and cobalt chromium alloy (ASTM F1537). System includes pedicle screws (4.35-9mm diameter, 20-100mm length), rods (5.5mm and 6.0mm diameter), locking caps, and polyaxial reduction heads. Non-sterile, single-use. Mechanical testing performed per ASTM F1717 and ASTM F1798.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for DDD, spondylolisthesis, trauma, spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion. Also indicated for pediatric patients with adolescent idiopathic scoliosis for posterior non-cervical pedicle screw fixation as an adjunct to fusion. Use with autograft/allograft required.

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, DePuy Spine, Inc. (K131802)
• Synthes MATRIX System, Synthes Spine (K120838)
• MOSS 100 Spinal System, Biedermann Motech (K162232)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 13, 2018

Biedermann Motech GmbH & Co. KG Mr. Gerd Federle Director of Quality Management Bertha-von-Suttner-Strasse 23 78054 Villingen-Schwenningen GERMANY

Re: K181821

Trade/Device Name: MOSS VRS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 5, 2018 Received: July 9, 2018

Dear Mr. Federle:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Ronald P. Jean -S

for 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) K181821

Device Name MOSS VRS Spinal System

#### Indications for Use (Describe)

The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.

The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications:

- 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. fractures or dislocations)
- Spinal Stenosis
- Curvatures (i.e. scoliosis, kyphosis and/ or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS system is indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The MOSS VRS system is 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)

| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" width="12" x="0" y="0"></rect> <path d="M2,2 L10,10 M2,10 L10,2" stroke="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" width="12" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/2 description: The image shows the text "BIEDERMANN MOTECH" in a bold, sans-serif font. The text is arranged in two lines, with "BIEDERMANN" on the top line and "MOTECH" on the bottom line. To the left of the text is a small, empty square, likely intended to be a checkbox.

## 510(k) Summary

#### 1. Submitter, Correspondent and Manufacturer

| Submitter Name: | Biedermann Motech GmbH & Co. KG |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | Bertha-von-Suttner-Str. 23<br>78054 Villingen-Schwenningen<br>Germany |
| Contact Person: | Gerd Federle<br>Director of Quality Management<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date of Submission: | 07/05/2018 |
| Manufacturer Name: | Biedermann Motech GmbH & Co. KG |
| Manufacturer Address: | Bertha-von-Suttner-Str. 23<br>78054 Villingen-Schwenningen<br>Germany |

### 2. Device Identification

| Device Trade Name: | MOSS VRS Spinal System | |
|-----------------------|-----------------------------------------|------------|
| Device Common Name: | Pedicle Screw System | |
| Classification Name: | Pedicle Screw Spinal Fixation | |
| Classification Code: | NKB | (Class II) |
| Classification Panel: | Orthopedic | |
| Regulation Number: | 21 CFR section 888.3070 | |
| Regulation Name: | Thoracolumbosacral Pedicle Screw System | |

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Biedermann Motech GmbH & Co. KG MOSS VRS Spinal System 510(k) Premarket Notification

# RMANN

### 3. Predicate Device

| Predicate Device: | EXPEDIUM Spine System, DePuy Spine, Inc. (K131802) |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Additional Predicates: | Synthes MATRIX System, Synthes Spine (K120838)<br>MOSS 100 Spinal System, Biedermann Motech (K162232) |

#### 4. Device Description

The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offers posterior clinical solutions. The MOSS VRS System is a universal set of instruments and implants that are indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation.

The MOSS VRS System provides several options for stabilization of the spine. Therefore, the system includes the following implants:

- -Pedicle Screws Ø4.35-9mm, length 20-100mm
- Rods Ø5,5mm and Ø6,0mm, length 30-95mm, 120-600mm =
- Locking Caps =
- -Polyaxial Reductionheads

The implants of the MOSS VRS System are single-use only and the system is provided non sterile.

#### 5. Material

The implants are manufactured from ASTM F 136 implant grade titanium alloy Ti-6Al-4V ELI and cobalt chromium alloy according to ASTM F1537.

### 6. Indications for Use

The MOSS VRS Spinal System is intended to provide immobilization and stabilization of spinal seqments 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 MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications:

- -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. fractures or dislocations) -

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Biedermann Motech GmbH & Co. KG MOSS VRS Spinal System 510(k) Premarket Notification

Image /page/5/Picture/2 description: The image contains the words "BIEDERMANN" and "MOTECH" stacked on top of each other. To the left of the words is a small square. The text is in a simple, sans-serif font and appears to be part of a logo or label.

- -Spinal Stenosis
- Curvatures (i.e. scoliosis, kyphosis and/ or lordosis) -
- -Tumor
- -Pseudoarthrosis
- -Failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MOSS VRS system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

### 7. Technological Characteristics and Substantial Equivalence

Like the predicate device (EXPEDIUM Spine System – K131802) the MOSS VRS Spinal System is a multiple component device. The implants are made from titanium alloy Ti-6Al-4V and cobalt chromium alloy that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The MOSS VRS spinal implant assembly consists of pedicle screws, reduction heads, locking caps and rods of a similar design as the predicate devices components.

The system is intended to provide immobilization and stabilization of spinal segments, as the predicate is

### 8. Performance Data

#### 8.1 Non-Clinical Test Summary

The MOSS VRS system was evaluated per the FDA Guidance Document for Industry and FDA Staff; Spinal System 510(k)s.

The following testing was done to show safety and effectiveness of our system:

#### Bench testing - mechanical

Mechanical testing according to ASTM F 1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) standard and to ASTM F1798 (Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants) standard was performed in order to provide data to support a substantial equivalence determination. These tests were performed to support system related performance. Performance testing included:

- Static Compression
- . Dynamic Compression
- Static Torsion ■
- Static Axial Pull-Off

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Biedermann Motech GmbH & Co. KG MOSS VRS Spinal System 510(k) Premarket Notification

Image /page/6/Picture/2 description: The image contains the words "BIEDERMANN" and "MOTECH" stacked on top of each other. To the left of the words is a small, empty square. The text is in a simple, sans-serif font and appears to be part of a form or document.

Result: The results of the worst case biomechanical testing of the MOSS VRS System indicate that the MOSS VRS System is substantially equivalent to the identified predicate device.

#### 8.2 Clinical Test Summary

No clinical tests were performed.

#### 9. Substantial Equivalence Summary and Conclusion

There are no differences between the devices which would raise new concerns regarding safety or effectiveness.

Based on available 510(k) information provided, comparison to predicate devices and performance testing, the MOSS VRS System can be considered substantially equivalent to the predicate device.