MOSS 100 Pedicle Screw System

K162232 · Biedermann Motech GmbH & Co. KG · NKB · Nov 17, 2016 · Orthopedic

Device Facts

• Record ID: K162232
• Device Name: MOSS 100 Pedicle Screw System
• Applicant: Biedermann Motech GmbH & Co. KG
• Product Code: NKB · Orthopedic
• Decision Date: Nov 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MOSS 100 Pedicle Screw System is a thoracolumbar pedicle fixation device for the following indications of use: - 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, kyphoses and/ or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion

Device Story

The MOSS 100 Pedicle Screw System is a posterior thoracolumbar spinal fixation system. It consists of pedicle screws, polyaxial heads, rods, and locking caps. The system is used by surgeons in an operating room to provide immobilization and stabilization of spinal segments. The surgeon intra-operatively mounts polyaxial heads onto pedicle screws and constructs an implant assembly to fit the patient's specific anatomical and physiological requirements. The device is intended to facilitate spinal fusion in patients with mechanical instability or deformity. The system is provided non-sterile and is for single-use only.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including static/dynamic compression and static torsion per ASTM F 1717, and static axial pull-off testing per ASTM F 1798.

Technological Characteristics

Constructed from ASTM F 136 titanium alloy (Ti-6Al-4V ELI). System includes pedicle screws (5-8mm diameter, 25-80mm length), rods (5.5mm diameter), polyaxial heads, and locking caps. Mechanical fixation principle. Provided non-sterile; requires sterilization. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion due to degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or 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

• Expedium Spine System (K041119)

Reference Devices

• Synthes Matrix Spine (K092929)

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

November 17, 2016

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

Re: K162232

Trade/Device Name: MOSS 100 Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: October 21, 2016 Received: October 24, 2016

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

# 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K162232

Device Name MOSS 100 Pedicle Screw System

#### Indications for Use (Describe)

The MOSS 100 Pedicle Screw System is a thoracolumbar pedicle for the following indications of use:

- 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, kyphoses and/ or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995,

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# 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 Prepared: | 10/21/2016 |
| 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 100 Pedicle Screw System |
| Device Common Name: | Pedicle Screw System |
| Classification Name: | Pedicle Screw Spinal fixation |
| Classification Code: | NKB, MNI and MNH (Class III) |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR section 888.3070 |
| Regulation Name: | Pedicle screw spinal system |

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Image /page/4/Picture/2 description: The image shows a logo with the text "BIEDERMANN" on the top line and "MOTECN" on the bottom line. The text is in a simple, sans-serif font. To the right of the text is a solid black square, which is partially overlapping the text. The text and the square are enclosed in a thin, black border.

### 3. Primary Predicate Device

K041119

Expedium Spine System, DePuy Spine, Inc.

## 4. Reference Device

K092929

Synthes Matrix Spine, Synthes (USA)

# 5. Device Description

The Biedermann Motech MOSS 100 Pedicle Screw System is a comprehensive thoracolumbar spinal system that offers posterior clinical solutions. The MOSS 100 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 100 System provides several options for stabilization of the spine. Therefore, the system includes the following implants:

- -Pedicle Screws Ø5-8mm, length 25-80mm
- -Rods Ø5.5mm, length 30-95mm, 300mm and 480mm
- Locking caps -
- Polyaxial Heads -

The Polyaxial Heads are mounted onto the Pedicle Screws intra-operatively. The implants of the MOSS 100 System are single-use only and the system is provided non sterile.

## 6. Material

The implants are manufactured from ASTM F 136 implant grade titanium alloy Ti-6Al-4V ELI.

## 7. Indications for Use

The MOSS 100 Pedicle Screw System is a thoracolumbar pedicle fixation device for the following indications of use:

- Deqenerative 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

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- Pseudoarthrosis -
- Failed previous fusion -

# 8. Technological Characteristics and Substantial Equivalence

Like the predicate devices (Expedium Spine System – K041119, Synthes Matrix Spine - K092929) the MOSS 100 Pedicle Screw Systems is a multiple component device, made from Titanium alloy Ti-6Al-4V that allows the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The MOSS 100 spinal implant assembly consists of pedicle screws, heads (interconnection mechanisms), 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 in skeletally mature patients, as the predicate is.

### 9. Performance Data

#### 9.1 Non-Clinical Test Summary

The MOSS 100 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 was performed in order to provide data to support a substantial equivalence determination. These tests were performed to support system related performance under consideration of well-established acceptance criteria. Performance testing included:

- Static Compression
- . Dynamic Compression
- . Static Torsion

Result: The results of the worst case mechanical testing of the MOSS 100 System indicate that the MOSS 100 system is substantially equivalent to the identified predicate device.

#### Additional Bench testing

Mechanical testing according to ASTM F 1798 (Standard Test Methods 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

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tests are performed to support system related performance under consideration of well-established acceptance criteria. Performance testing included:

- " Static axial pull-off test
Results: Review and comparison of the data shows the subjects Biedermann Motech device has higher mechanical characteristics than the reference product. The test data supports substantial equivalence of performance of the Biedermann Motech subject device and reference product.

## 9.2 Clinical Test Summary

No clinical tests were performed.