NEON SYSTEM

K113346 · Ulrich GmbH & Co. KG · KWP · Feb 28, 2012 · Orthopedic

Device Facts

• Record ID: K113346
• Device Name: NEON SYSTEM
• Applicant: Ulrich GmbH & Co. KG
• Product Code: KWP · Orthopedic
• Decision Date: Feb 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to provide immobilization and stabilization as an adjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw, connector and crosslink components of neon™ are indicated for the treatment of: • DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), • spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors The cortical (3.5mm) bone screws are limited to occipital fixation only. The hook, rod and crosslink component placement is indicated for the cervical/upper thoracic (C1-T3) spine. The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine.

Device Story

Modular posterior spinal fixation system; used for surgical stabilization of occipito-cervico-thoracic regions. Components include longitudinal members (hybrid plate/rods, straight rods), anchors (self-drilling/self-tapping screws, hooks), and interconnecting devices (anchor-to-rod connectors, rod-to-rod crosslinks). Operated by surgeons in clinical/OR settings. Provides mechanical immobilization to facilitate spinal fusion. Benefits patients by stabilizing spine segments affected by degenerative disease, trauma, or tumors.

Clinical Evidence

Bench testing only. Mechanical testing of worst-case constructs included static and dynamic compression bending per ASTM F1717, and static and dynamic compression bending and torsion per ASTM F2076. Results demonstrate performance equivalent or superior to predicate devices.

Technological Characteristics

Materials: Titanium (Ti Grade 2, ASTM F67) or titanium alloy (Ti-6Al-4V, ASTM F136). Design: Modular rod-based system with screw/hook anchors, connectors, and crosslinks. Dimensions comparable to predicate systems. No software or energy source.

Indications for Use

Indicated for patients requiring immobilization/stabilization as adjunct to fusion of cervical spine and occipito-cervico-thoracic junction (occiput-T3) for DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, or tumors. Cortical screws limited to occipital fixation; other screws limited to T1-T3.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Ascent POCT System (K033480 and K073420)
• Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060)
• CerviFix® System (K030377 and K011966)

Submission Summary (Full Text)

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K113346

FEB 2 8 2012

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## 510(k) Summary

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| Date: | 10 November 2011 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | ulrich GmbH & Co. KG<br>Buchbrunnenweg 12<br>89081 Ulm<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Hans Stover<br>ulrich medical USA, Inc.<br>612 Trade Center Blvd.<br>Chesterfield, MO 63005<br>[phone] Office<br>[phone] Fax |
| Proposed Trade<br>Name: | neon™ |
| Device Classification | Class II |
| Classification Name: | Spinal interlaminal fixation orthosis |
| Regulation: | 888.3050 |
| Device Product<br>Code: | KWP |
| Device Description: | neon™ is a modular, posterior system used for the surgical<br>stabilization and fixation of the occipito-cervico-thoracic regions of<br>the spine. If necessary, the occipito-cervical junction as well as the<br>cervico-thoracic junction may be included. The system components<br>include longitudinal members such as hybrid plate/rods and straight<br>rods, anchors such as self-drilling and self-tapping screws and<br>hooks, and interconnecting devices such as anchor-to-rod<br>connectors and a rod-to-rod crosslink. |
| Intended Use: | When intended to provide immobilization and stabilization as an<br>adjunct to fusion of the cervical spine and the occipito-cervico-<br>thoracic junction (occiput-T3), the plate/rod, rod, hook, screw,<br>connector and crosslink components of neon™ are indicated for the<br>treatment of:<br>• DDD (neck pain of discogenic origin with degeneration of the<br>disc as confirmed by patient history and radiographic<br>studies),<br>• spondylolisthesis, |
| | spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors |
| | The cortical (3.5mm) bone screws are limited to occipital fixation only. |
| | The hook, rod and crosslink component placement is indicated for the cervical/upper thoracic (C1-T3) spine. |
| | The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine. |
| Materials: | neonTM components are manufactured from titanium (Ti Grade 2, ASTM F67) or titanium alloy (Ti-6Al-4V) as described by ASTM F136: |
| Predicate Devices: | Ascent POCT System (K033480 and K073420)<br>Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060)<br>CerviFix® System (K030377 and K011966) |
| Technological<br>Characteristics: | neonTM possesses the same technological characteristics as one or more of the predicate devices. These include: intended use (as described above) basic design (rod-based having screw and/or hook anchors), material (titanium / titanium alloy), sizes (dimensions are comparable to those offered by the predicate systems) and The fundamental scientific technology of neonTM is the same as previously cleared devices. |
| Performance Data: | Mechanical testing of the worst case neonTM constructs included static and dynamic compression bending according to ASTM F1717, and static and dynamic compression bending and torsion according to ASTM F2076.<br>The mechanical test results demonstrate that neonTM performs as well as or better than the predicate devices and therefore that the device is as safe and as effective as the predicates. |

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

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

Ulrich GmbH & Co., KG % Ulrich Medical USA. Inc. Mr. Hans Stover 612 Trade Center Boulevard Chesterfield, Missouri 63005

FEB 2 8 2012

Re: K113346 Trade/Device Name: neon™ Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: February 11, 2012 Received: February 14, 2012

Dear Mr. Stover:

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

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Page 2 - Mr. Hans Stover

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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.html

Sincerely yours.

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

Enclosure

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## K113346

## Indications for Use Statement

510(k) Number:

Device Name: neon™

Indications for Use:

When intended to provide immobilization and stabilization as an adjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw, connector and crosslink components of neon™ are indicated for the treatment of

- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies),
- spondylolisthesis, ●
- spinal stenosis, ●
- fracture/dislocation, .
- atlantoaxial fracture with instability, .
- occipitocervical dislocation, .
- revision of previous cervical spine surgery, and .
- tumors ●

The cortical (3.5mm) bone screws are limited to occipital fixation only.

The hook, rod and crosslink component placement is indicated for the cervical/upper thoracic (C1-T3) spine.

The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine.

| Prescription Use X | AND/OR |
|------------------------|--------|
| (21 CFR 801 Subpart D) | |

Over-the-Counter Use_

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K113346

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