S4 Cervical Spinal and Occiput Systems

K151938 · Aesculap Implant Systems, LLC · NKG · Oct 21, 2015 · Orthopedic

Device Facts

• Record ID: K151938
• Device Name: S4 Cervical Spinal and Occiput Systems
• Applicant: Aesculap Implant Systems, LLC
• Product Code: NKG · Orthopedic
• Decision Date: Oct 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput 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. In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.

Device Story

S4 Cervical Spinal and Occiput Systems are orthopedic implant sets designed for spinal stabilization and fusion. Components include titanium alloy plates, bone screws, rods, hooks, and connectors. System facilitates immobilization of craniocervical, cervical, and thoracic spinal segments. Occipital plates attach to the skull via bone screws; polyaxial screws stabilize the construct to the upper thoracic spine. Surgeons use the system in clinical settings to treat spinal fractures, dislocations, tumors, and degenerative conditions. The device restores spinal column integrity, acting as an adjunct to fusion or as a temporary stabilizer in palliative tumor cases. It may be integrated with the Aesculap S4 Lumbar System for extended fixation. Benefits include mechanical stabilization of the spine to support biological fusion or structural support in patients with limited life expectancy.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including static and dynamic torsion and compression testing performed in accordance with ASTM F1717-04 and ASTM Work Item 455-Z9592Z.

Technological Characteristics

Materials: Titanium alloy. Components: 3.5mm rods, thin/thick lamina hooks, 3.5mm and 4.0mm polyaxial screws, cross connectors, occipital plates. Mechanical fixation via locking mechanisms. Non-sterile. Testing standards: ASTM F1717-04, ASTM Work Item 455-Z9592Z.

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) due to trauma, deformity, failed fusion, tumors, or degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in patients with advanced cervical tumors with limited life expectancy.

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)

Reference Devices

• Aesculap S4C Spinal System (K050979)
• Aesculap S4C Spinal System (Additional lengths polyaxial screws) (K060152)
• Aesculap S4C Spinal System: Occiput Plate (K062012)
• Aesculap S4C Spinal System (Modification to Cross Connector & Add. Smooth Shank Screws) (K062327)
• Aesculap S4C Mini-Occiput Spinal System (K100147)

Submission Summary (Full Text)

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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

October 21, 2015

Aesculap Implant Systems, LLC Ms. Lisa M. Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K151938

Trade/Device Name: S4 Cervical Spinal and Occiput Systems Regulatory Class: Unclassified Product Code: NKG, KWP Dated: September 21, 2015 Received: September 22, 2015

Dear Ms. Boyle:

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 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.

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Page 2 - Ms. Lisa M. Boyle

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/Resourcesfor You/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 yours,

# 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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# Indications for Use

510(k) Number (if known) K151938

Device Name S4 Cervical Spinal and Occiput Systems

#### Indications for Use (Describe)

The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput 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.

In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <div><span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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### 510(k) SUMMARY (as required by 21 CFR 807.92)

#### Aesculap® Implant Svstems (AIS), LLC. S4 Cervical Spinal and Occiput Systems

September 21, 2015

| COMPANY: | Aesculap®Implant Systems (AIS), LLC |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| | 3773 Corporate Parkway |
| | Center Valley, PA 18034 |
| | Establishment Registration Number: 3005673311 |
| CONTACT: | Lisa M. Boyle |
| | 800-258-1946 (phone) |
| | 610-791-6882 (fax) |
| TRADE NAME: | S4 Cervical Spinal and Occiput Systems |
| COMMON NAME: | Posterior, Cervical Pedicle Screw Spine Fixation, Spinal<br>Interlaminal Fixation Orthosis, Posterior Cervical System |
| CLASSIFICATION NAME: | Posterior, Cervical Pedicle Screw Spine Fixation |
| | Orthopaedic and Rehabilitation Devices Panel |
| | Unclassified; Pre-Amendment Device |
| | Product Code: NKG |
| | Appliance, Fixation, Spinal Interlaminal |
| | Orthopaedic and Rehabilitation Devices Panel |
| | Class 2 per 21 CFR 888.3050 |
| | Product Code: KWP |

### PURPOSE FOR PREMARKET NOTIFICATION

The Aesculap S4 Cervical Spinal and Occiput Systems described in this submission represent an expanded indication for the entire S4 Cervical System, including the Aesculap S4C Spinal System cleared under K050979, the Aesculap S4C Spinal System (Additional lengths polyaxial screws) cleared under K060152, the Aesculap S4C Spinal System: Occiput Plate cleared under K062012, the Aesculap S4C Spinal System (Modification to Cross Connector & Add. Smooth Shank Screws) cleared under K062327, and the Aesculap S4C Mini-Occiput Spinal System cleared under K100147.

### DEVICE DESCRIPTION

The Aesculap S4 Cervical Spinal and Occiput Systems are implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote

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fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap S4 Cervical Spinal and Occiput Systems consist of plates, bone screws, rods, hooks, and connectors. This consists of 3.5mm rod, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and cross connectors. The occipital plate is fixed to the occiput with bone screws and the transition by a locking mechanism. The end of the construct is stabilized with polyaxial screws to the upper thoracic spine, as required. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap S4 Cervical Spinal and Occiput Systems are manufactured from Titanium alloy and will be provided non-sterile.

### INDICATIONS FOR USE

The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput 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.

In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.

#### TECHNOLOGICAL CHARACTERISTICS(compared to Predicates)

As is established in this submission, the Aesculap S4 Cervical Spinal and Occiput Systems are substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.

#### PERFORMANCE DATA

Published literature and Non-clinical testing demonstrate that the Aesculap S4 Cervical Spinal and Occiput Systems are substantially equivalent to other predicate devices. The following testing was performed:

- Static Torsion Bending per ASTM F1717-04 and ASTM Work Item 455-● Z9592Z (Test No. V684-A)

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- . Dynamic Torsion Testing per ASTM F1717-04 and ASTM Work Item 455-Z9592Z (Test No. V809)
- Dynamic Compression Testing per ASTM F1717-04 and ASTM Work Item . 455-Z9592Z (Test No. V697)
- Static Compression Bending per ASTM F1717-04 and ASTM Work Item 455-Z9592Z (Test No. V683-A)

The results showed that the subject Aesculap S4 Cervical Spinal and Occiput Systems meet or exceed the performance of the predicate devices, and the device is therefore found to be substantially equivalent.

# PREDICATE DEVICE

- Synapse Occipital-Cervical-Thoracic (OCT) System (K142838) ●
# REFERENCE DEVICES

- Aesculap S4C Spinal System (K050979) ●
- Aesculap S4C Spinal System (Additional lengths polyaxial screws) (K060152) .
- . Aesculap S4C Spinal System: Occiput Plate (K062012)
- . Aesculap S4C Spinal System (Modification to Cross Connector & Add. Smooth Shank Screws) (K062327)
- . Aesculap S4C Mini-Occiput Spinal System (K100147)