PASS OCT SPINAL SYSTEM

K121979 · Medicrea International · KWP · Mar 21, 2013 · Orthopedic

Device Facts

• Record ID: K121979
• Device Name: PASS OCT SPINAL SYSTEM
• Applicant: Medicrea International
• Product Code: KWP · Orthopedic
• Decision Date: Mar 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for: - Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. - Spondylolisthesis - Spinal Stenosis - Trauma (i.e. Fracture or Dislocation) - Atlanto/axial fracture with instability - Revision of previous cervical spine surgery - Tumors Occipital Plates / Occipital Bone Screws / Hooks: The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only. The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs. Hooks and rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Polyaxial screws/Connectors: The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine. The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.

Device Story

Posterior spinal fixation system; consists of rods, hooks, polyaxial screws, occipital plates, and bone screws. Designed for immobilization and stabilization of occipitocervical, cervical, and upper-thoracic (Occiput-T3) spinal segments as adjunct to fusion. Implants rigidly locked in various configurations to stabilize spine during bony consolidation. Used in surgical settings by neurosurgeons or orthopedic surgeons. Polyaxial screws limited to T1-T3 for construct anchoring; occipital screws limited to occipital fixation. System compatible with PASS LP Spinal System via dual diameter rod. Benefits patient by providing structural support to facilitate spinal fusion and stability following trauma or degenerative conditions.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical bench testing including static compression, dynamic compression, static torsion, and dynamic torsion per ASTM F2706-08 and FDA guidance for spinal systems.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136-11/ISO 5832-3 and PEEK OPTIMA LT1 per ASTM F2026-10. Components: Rods, hooks, polyaxial screws, occipital plates, occipital bone screws. Mechanical fixation via rigid locking configurations. Non-sterile; intended for surgical implantation.

Indications for Use

Indicated for patients requiring stabilization and fusion of the occipitocervical, cervical, and upper-thoracic spine (Occiput-T3) due to Degenerative Disc Disease, spondylolisthesis, spinal stenosis, trauma (fracture/dislocation), atlanto/axial instability, revision surgery, or tumors.

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

• Summit Occipito-Cervico-Thoracic (OCT) Spinal System (K002733)
• Mountaineer OCT Spinal System (K042508)
• PASS 2 Spinal System (K062136)
• Vertex Reconstruction System (K003780)

Submission Summary (Full Text)

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A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

MAR 2 1 2013

| K Number | K121979 | | |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------|
| Submitter Information | | | |
| Name | MEDICREA INTERNATIONAL | | |
| Address | 14 Porte du Grand Lyon<br>01700 Neyron, FRANCE | | |
| Phone number | 04 72 01 87 87 | | |
| Fax number | 04 72 01 87 88 | | |
| Establishment<br>registration<br>Number | 1000432246 | | |
| For Information<br>Contact | Audrey VION<br>Regulatory Affairs Manager<br>MEDICREA INTERNATIONAL<br>14 Porte du Grand Lyon<br>01700 NEYRON<br>France<br>Telephone : [phone]<br>Fax : [phone]<br>Email : [e-mail] | | |
| Date Prepared | March 20, 2013 | | |
| Name of Device | | | |
| Trade or<br>Proprietary Name | PASS OCT Spinal System | | |
| Common or Usual<br>name | Spinal Fixation Appliances | | |
| Classification name<br>and Reference | Spinal Interlaminal Fixation Orthosis 21 CFR 888.3050 | | |
| Classification | Class II | | |
| Product code(s) | KWP: Appliance, Fixation, Spinal Interlaminal | | |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | 510(k)<br>Number | Title | Date<br>Cleared |
| | K002733 | Summit Occipito-Cervico-Thoracic<br>(OCT) Spinal System | 12/15/00 |
| | K042508 | Mountaineer OCT Spinal System | 7/10/04 |
| | K062136 | PASS 2 Spinal System | 6/10/06 |
| | K003780 | Vertex Reconstruction System | 9/28/01 |
| Device Description | The PASS OCT Spinal System is a posterior system, which consists<br>of a variety of shapes and sizes of rods, hooks, polyaxial screws,<br>occipital plates, occipital bone screws, and connecting<br>components, which can be rigidly locked to the rod in a variety of<br>configurations. See package insert of the system for labeling<br>limitations.<br>The implants are manufactured from titanium alloy Ti-6Al-4V ELI<br>conforming to ISO 5832-3 specifications and ASTM F136<br>specifications and in PEEK OPTIMA LT1 conforming to ASTM<br>E2026 specifications | | |

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Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use any of the PASS OCT Spinal System implant components with components from any other systems or manufacturer unless specifically labeled to do so in this or another MEDICREA INTERNATIONAL document. As with all orthopedic and neurosurgical implants, none of the PASS OCT Spinal components should ever be reused under any circumstances. MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F136-11 & ISO 5832-30 and PEEK OPTIMA LT1® according to the ASTM F2026-10. MEDICREA" INTERNATIONAL PASS OCT implants are designed to Intended use of the device help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thotacic spine (occiput-T3). These devices should not be used in the inferior thoracic, lumbar and sacral region. These implants are designed to stabilize the spine during normal development of solid bony consolidation. After this period the device is no longer strictly necessary and may be removed. Indications for use When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for: - Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. - Spondylolisthesis - Spinal Stenosis - Trauma (i.e. Fracture or Dislocation) - Atlanto/axial fracture with instability - Revision of previous cervical spine surgery - Tumors Occipital Plates / Occipital Bone Screws / Hooks: The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only. The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs. Hooks and rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Polyaxial screws/Connectors: The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine. The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.

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| Performance Data | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| SUMMARY OF NON-CLINICAL TEST CONDUCTED FOR DETERMINATION OF SUBSTANTIAL<br>EQUIVALENCE | |
| Performance test Summary-New Device | |
| Characteristic | Standard/Test/FDA Guidance |
| Multi-axial screws & Rods Constructs | |
| Static Compression | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Dynamic<br>Compression | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Static Torsion | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Occipital Plates, Occipital Screws & Dual Diameter Rod Constructs | |
| Static Compression | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Dynamic<br>Compression | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Static Torsion | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| Dynamic Torsion | ASTM F2706-08 / Guidance of Spinal System 510(k)s |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL<br>EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| Not Applicable | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to the<br>SUMMIT System (K002733), the Mountaineer OCT Spinal System (K042508), the Vertex<br>Reconstruction System (K052734), in terms of intended use, materials used, design,<br>mechanical safety and performances. | |
| And MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to<br>the PASS 2 Spinal System (K062136) in terms of materials used and design. | |
| The MEDICREA® INTERNATIONAL PASS OCT Spinal System is safe and effective and<br>performs as well as the predicates SUMMIT Spinal System (K041203), the Mountaineer<br>OCT Spinal System (K042508), the Vertex Reconstruction System (K52734), and the<br>PASS 2 Spinal System (KO62136). | |

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Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines representing its wings and body.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 21, 2013

Medicrea International % Ms. Audrey Vion Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron France

Re: Kil21979

Trade/Device Name: PASS OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: January 16, 2013 Received: February 15, 2013

Dear Ms. Vion:

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

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# Page 2 - Ms. Audrey Vion

forth in 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 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/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.

# Erin Deith

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

Enclosure

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#### STATEMENT OF INDICATIONS FOR USE

#### 510(k) Number (if known): K121979

## Device Name: PASS OCT Spinal System

When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:

- Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration
- of the disc as confirmed by patient history and radiographic studies.
- Spondylolisthesis
- Spinal Stenosis
- Trauma (i.e. Fracture or Dislocation)
- . Atlanto/axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors

#### Occipital Plates / Occipital Bone Screws / Hooks:

The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.

The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.

#### Hooks and rods:

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

#### Polyaxial screws/Connectors:

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.

The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.

Prescription Use > (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Erin l Keith

#### Division of Orthopedic Devices

510(k) Number: K121979