TASMIN R

K123758 · Signus Medizintechnik GmbH · MQP · Jan 14, 2014 · Orthopedic

Device Facts

• Record ID: K123758
• Device Name: TASMIN R
• Applicant: Signus Medizintechnik GmbH
• Product Code: MQP · Orthopedic
• Decision Date: Jan 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. When used as an intervertebral fusion device, the TASMIN® R devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

Device Story

TASMIN® R is a hollow, structural spinal implant with a rounded, tapered leading face and peaked teeth for anchoring; lateral fenestrations allow for bony in-growth. Used by surgeons in the OR for vertebral body replacement or intervertebral fusion. Implanted between vertebral bodies to provide structural support and facilitate fusion when used with autograft and supplemental internal fixation. Benefits include stabilization of the spinal column and restoration of disc height in patients with degenerative conditions or trauma.

Clinical Evidence

Bench testing only. Performance validated via finite element analysis and mechanical testing per ASTM F2077 (static/dynamic compression, torsion, compression shear) and ASTM F2267 (subsidence). No clinical data provided.

Technological Characteristics

Hollow structural frame; material: PEEK-OPTIMA® LT1 (ASTM F2026) with tantalum marker pins (ASTM F560); features lateral fenestrations and peaked teeth for anchoring. Dimensions vary by pathology. Non-active, mechanical implant.

Indications for Use

Indicated for patients requiring vertebral body replacement (T1-L5) due to tumor or trauma/fracture, or lumbar intervertebral fusion (L2-S1) for degenerative disc disease with up to Grade I spondylolisthesis after six months of failed non-operative treatment.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• PEEK TETRIS™ (SIGNUS - K031757, K111792)
• MC+ (LDR Spine USA - K043479)
• Hourglass (Medtronic Sofamor Danek - K033926)
• Ray TFC (Surgical Dynamics – P950019)
• CoRoent® (NuVasive Inc. - K071795)
• Capstone Control (Medtronic Sofamor Danek - K120368)

Submission Summary (Full Text)

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K123758
Page 1 of 2

JAN 1 4 2014

| 510(k) Summary | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 30 November 2012 |
| Sponsor: | SIGNUS Medizintechnik GmbH |
| | Industriestrasse 2 |
| | D-63755 Alzenau, GERMANY |
| | Tel. + 49 (0) 6023 9166-0 |
| | Fax + 49 (0) 6023 9166-161 |
| | Url: http://www.signus-med.de |
| Contact Person: | Joachim Schneider, Quality Management/Regulatory Affairs |
| Trade Names: | TASMIN® R |
| Device Classification | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis; Intervertebral body fusion<br>device |
| Common Name: | Vertebral Body Replacement Device; Interbody Fusion Device |
| Regulation: | 888.3060; 888.3080 |
| Device Product<br>Codes: | MQP; MAX |
| Device Description: | The basic shape of the TASMIN® R devices is a hollow structural frame<br>having a rounded, tapered leading face. The upper and lower aspects<br>of the implant are open with peaked teeth that assist in anchoring and<br>seating the implant between the vertebral bodies. There are lateral<br>fenestrations for bony in-growth. The device is available in a variety of<br>sizes and angulations thereby enabling the surgeon to choose the size<br>best suited to the individual pathology and anatomical condition. |
| Intended Use: | When used as a vertebral body replacement, the TASMIN® R devices<br>are indicated for use to replace a vertebral body that has been resected<br>or excised due to tumor or trauma/fracture. The device is intended for<br>use as a vertebral body replacement in the thoracolumbar spine (from<br>T1 to L5) and is intended for use with supplemental internal fixation.<br>When used as an intervertebral fusion device, the TASMIN® R devices<br>are intended for use at one level in the lumbar spine, from L2 to S1, for<br>the treatment of degenerative disc disease (DDD) with up to Grade I<br>spondylolisthesis. DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies.<br>The lumbar device is to be used in patients who have had six months<br>of non-operative treatment. The devices are intended for use with a<br>supplemental internal fixation system and with autograft to facilitate<br>fusion. |
| Materials: | The TASMIN® R devices are manufactured from polyetheretherketone<br>(PEEK-OPTIMA® LT1, Invibio®) as described by ASTM F2026. Integral<br>marker pins used in the PEEK devices are manufactured from tantalum<br>as described by ASTM F560. |
| Predicate Devices: | PEEK TETRIS™ (SIGNUS - K031757, K111792)<br>MC+ (LDR Spine USA - K043479)<br>Hourglass (Medtronic Sofamor Danek - K033926)<br>Ray TFC (Surgical Dynamics – P950019)<br>CoRoent® (NuVasive Inc. - K071795)<br>Capstone Control (Medtronic Sofamor Danek - K120368) |
| Performance Data: | Finite element analysis simulations of the worst case TETRIS™ and<br>TASMIN® R devices were compared. The simulations included those<br>prescribed by ASTM F2077 (compression, torsion and compression<br>shear).<br><br>Static and dynamic compression testing of the worst case TASMIN® R<br>devices was performed according to ASTM F2077. In addition, the<br>subsidence properties were evaluated according to ASTM F2267.<br>The results demonstrated that the TASMIN® R device performance is<br>substantially equivalent to the predicate devices. |
| Technological<br>Characteristics: | The TASMIN® R devices possess the same technological<br>characteristics as the predicate devices. These include:<br>• performance (as described above),<br>• basic design (hollow structural frame),<br>• material (PEEK polymer and tantalum), and<br>• sizes (widths, lengths and heights are within the range(s)<br>offered by the predicate).<br>Therefore the fundamental scientific technology of the TASMIN® R<br>devices is the same as previously cleared devices. |
| Conclusion: | The TASMIN® R devices possess the same intended use and |

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technological characteristics as the predicate devices. Therefore the
TASMIN® R is substantially equivalent for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

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

January 14, 2014

SIGNUS Medizintechnik GmbH % Karen Warden, Ph.D. President BackRoads Consulting, Incorporated P.O. Box 566 Chesterland, Ohio 44026-2141

Re: K123758

Trade/Device Name: TASMIN® R · Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP, MAX Dated: November 19, 2013 Received: November 21, 2013

Dear Dr. Warden:

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 - Karen Warden, Ph.D

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,

## Lori A. Wiggins

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

Enclosure

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## 7. Indications for Use Statement

510(k) Number: K123758

Device Name: TASMIN® R

Indications for Use:

When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as an intervertebral fusion device, the TASMIN® R devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

Prescription Use X

OR Over-the-Counter Use

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Anton E. Dmitriev, PhD

Division of Orthopedic Devices