neon3™ universal OCT spinal stabilization

K161032 · Ulrich GmbH & Co. KG · NKG · Dec 22, 2016 · Orthopedic

Device Facts

• Record ID: K161032
• Device Name: neon3™ universal OCT spinal stabilization
• Applicant: Ulrich GmbH & Co. KG
• Product Code: NKG · Orthopedic
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease. including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. neon3™ is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration of fusion.

Device Story

Modular posterior spinal stabilization system; used for surgical fixation of occipital, cervical, and thoracic spine. Components include longitudinal rods, screw/hook anchors, and interconnecting devices (anchor-to-rod, rod-to-rod, screw-to-screw crosslinks). Operated by surgeons in clinical/OR settings. Provides mechanical immobilization of spinal segments to facilitate fusion or restore column integrity in tumor patients. Surgeon selects and assembles components intraoperatively to match patient anatomy; output is a rigid construct providing structural support. Benefits include stabilization of unstable spinal segments and pain relief associated with degenerative or traumatic conditions.

Clinical Evidence

Bench testing only. Mechanical testing of worst-case craniocervical constructs performed per ASTM F1717 (static/dynamic compression bending, static torsion) and ASTM F2706 (static/dynamic compression bending, static/dynamic torsion). Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Modular posterior spinal system. Materials: Grade 2 titanium (ASTM F67), Ti-6Al-4V titanium alloy (ASTM F136), Cobalt Chrome (ASTM F1537). Components: longitudinal rods, screw/hook anchors, crosslinks, connectors. Mechanical fixation principle. No software or energy source.

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical (C1-C7) and thoracic (T1-T3) spine requiring immobilization as adjunct to fusion. Conditions include traumatic fractures/dislocations, instability/deformity, pseudarthrosis, tumors, and degenerative disease (radiculopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in patients with advanced cervical tumors where life expectancy precludes fusion.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• Synapse Occipital-Cervical-Thoracic (OCT) System (K142838)
• Halifax Interlaminar Clamp (K962314)
• neon3TM (K150650)
• Ascent™ POCT System (K033480, K073420)

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

December 22, 2016

ulrich GmbH & Co. KG % Mr. Hans Stover President and CEO ulrich medical USA, Inc. 18221 Edison Avenue Chesterfield, Missouri 63005

Re: K161032

Trade/Device Name: neon3TM universal OCT spinal stabilization Regulatory Class: Unclassified Product Code: NKG, KWP Dated: December 2, 2016 Received: December 5, 2016

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 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 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.

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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

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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# VincentJ. Devlin -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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#### 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 on last page.

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

### K161032

#### Device Name

neon3TM universal OCT spinal stabilization

#### Indications for Use (Describe)

neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease. including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. neon3™ is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration of 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)

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## Section 8 – 510(k) Summary

Image /page/4/Picture/1 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is written in a bold, slanted font, with the "U" extending into a black square on the left side. Below the word "Ulrich" is the text "medical USA" in a smaller, non-bold font.

| Date: | 2 December 2016 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | ulrich GmbH & Co. KG |
| | Buchbrunnenweg 12 |
| | 89081 Ulm |
| | Germany |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Hans Stover |
| | ulrich medical USA, Inc. |
| | 18221 Edison Avenue |
| | Chesterfield, MO 63005 |
| | [phone] Office |
| | [phone] Fax |
| Trade Name: | neon3™ universal OCT spinal stabilization |
| Common Name: | Posterior occipital-cervical-thoracic system, |
| | Cervical Pedicle Screw Spine Fixation |
| Device Classification: | Unclassified |
| | Orthopaedic and Rehabilitation Devices Panel |
| | Product Code: NKG, KWP |
| Submission Purpose: | To add occipital-cervical and cervicothoracic construct components to the<br>cleared neon3™ system including rods, plates, screws, hooks, crosslinks<br>and fasteners. |
| Device Description: | neon3™ is a modular, posterior system used for the surgical stabilization and<br>fixation of the occipital, cervical and thoracic regions of the spine. The<br>system components include longitudinal rods, screw and hook anchors, and<br>interconnecting devices such as anchor- to-rod connectors, and rod-to-rod<br>and screw-to-screw crosslinks. |
| Indications for Use: | neon3™ is intended to provide immobilization and stabilization of spinal<br>segments as an adjunct to fusion for the following acute and chronic<br>instabilities of the craniocervical junction, cervical spine (C1 to C7) and the<br>thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic<br>dislocations; instability or deformity; failed previous fusions (e.g.<br>pseudarthrosis); tumors involving the cervical/thoracic spine; and<br>degenerative disease, including intractable radiculopathy and/or<br>myelopathy, neck and/or arm pain of discogenic origin as confirmed by<br>radiographic studies, and degenerative disease of the facets with instability.<br>neon3™ is also intended to restore the integrity of the spinal column even in<br>the absence of fusion for a limited time period in patients with advanced<br>stage tumors involving the cervical spine in whom life expectancy is of |
| Materials: | neon3TM components are manufactured from Grade 2 titanium (ASTM F67),<br>Ti-6Al-4V titanium alloy (ASTM F136) or Cobalt Chrome (ASTM F1537) |
| Primary Predicate: | Synapse Occipital-Cervical-Thoracic (OCT) System (DePuy Synthes Spine,<br>K142838) |
| Additional Predicates: | Halifax Interlaminar Clamp (Osteonics- K962314), neon3TM (K150650 –<br>ulrich medical GmbH & Co. KG) and Ascent™ POCT System (Blackstone<br>Medical, K033480 and K073420) |
| Performance Data: | Mechanical testing of worst case neon3TM craniocervical constructs included<br>static and dynamic compression bending and static torsion according to<br>ASTM F1717 as well as static and dynamic compression bending and static<br>and dynamic torsion per ASTM F2706.<br>The mechanical test results demonstrate that neon3TM performance is<br>substantially equivalent to the predicate devices. |
| Technological<br>Characteristics: | neon3TM possesses technological characteristics similar to one or more of<br>the predicate devices. These include:<br>x intended use (as described above)<br>x basic design (rod-based having screw and/or hook anchors),<br>x material (titanium / titanium alloy),<br>x sizes (dimensions are comparable to those offered by the predicate<br>systems) and<br>Minor differences in technological characteristics were identified and shown<br>to not raise new questions of safety and effectiveness. Therefore the<br>fundamental scientific technology of neon3TM is the same as previously<br>cleared devices. |
| Conclusion: | neon3TM possesses the same intended use and technological<br>characteristics as the predicate devices. Therefore neon3TM is substantially<br>equivalent for its intended use. |

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