Who is the manufacturer of PASS OCT Spinal System?

Medicrea International SA filed the 510(k) submission for PASS OCT Spinal System (K150918).

What is the FDA product code for PASS OCT Spinal System?

NKG. It is classified under 21 CFR 888.3075 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PASS OCT Spinal System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PASS OCT Spinal System?

Vertex Reconstruction System (K143471); Virage OCT Spinal Fixation System (K133556); PASS OCT Spinal System (K121979).

Who can help prepare an FDA 510(k) submission like PASS OCT Spinal System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PASS OCT Spinal System

K150918 · Medicrea International SA · NKG · Oct 16, 2015 · Orthopedic

Device Facts

Record ID	K150918
Device Name	PASS OCT Spinal System
Applicant	Medicrea International SA
Product Code	NKG · Orthopedic
Decision Date	Oct 16, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3075
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PASS OCT Spinal System is 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 from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 PASS OCT Spinal System 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 to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT Spinal System may be connected to the PASS LP Spinal System rods with the dual diameter rods. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use.

Device Story

PASS OCT Spinal System is a posterior spinal fixation system consisting of rods, hooks, polyaxial screws, and occipital plates/screws. Used by surgeons in clinical settings to immobilize and stabilize spinal segments as an adjunct to fusion or for palliative stabilization in tumor patients. Components are rigidly locked to rods in various configurations to provide mechanical resistance and stability. System may connect to PASS LP Spinal System via dual-diameter rods for extended fixation. Device provides structural support to the spinal column; clinical benefit includes stabilization of unstable segments and facilitation of spinal fusion.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by mechanical bench testing (dynamic compression per ASTM F2706-08) and published literature.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V, ASTM F136/ISO 5832-3), CP Titanium (ASTM F67/ISO 5832-2), PEEK OPTIMA LT1 (ASTM F2026), Cobalt-chromium molybdenum alloy (ASTM F1537/ISO 5832-12). Components: Polyaxial screws, hooks, occipital plates, rods (3.5mm). Mechanical fixation via rigid locking. Non-sterile (implied by standard surgical implant requirements).

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) including traumatic fractures/dislocations, instability/deformity, failed fusions, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column restoration in advanced cervical tumor patients with limited life expectancy where fusion is not achievable.

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

Vertex Reconstruction System (K143471)
Virage OCT Spinal Fixation System (K133556)
PASS OCT Spinal System (K121979)

Related Devices

K160756 — PASS OCT Spinal System · Medicrea International SA · Apr 26, 2016
K161149 — PASS OCT Spinal System · Medicrea International SA · Jul 11, 2016
K181350 — ASTRA-OCT Spine System · Spinecraft, LLC · Jul 6, 2018
K013442 — PASS SPINAL SYSTEM · Encore Orthopedics, Inc. · Jan 15, 2002
K142838 — Synapse Occipital-Cervical-Thoracic (OCT) System · Synthes USA Products, LLC · Jan 20, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 16, 2015 Medicrea International S.A. Mr. Jean-Denys Marechal Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron FRANCE Re: K150918 Trade/Device Name: PASS OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: October 2, 2015 Received: October 7, 2015 Dear Mr. Marechal: 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 {1}------------------------------------------------ Page 2 - Mr. Jean-Denys Marechal 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150918 Device Name PASS OCT Spinal System ### Indications for Use (Describe) The PASS OCT Spinal System is 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 from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 PASS OCT Spinal System 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 to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT Spinal System may be connected to the PASS LP Spinal System rods with the dual diameter rods. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use. | 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) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 510(k) SUMMARY # MEDICREA INTERNATIONAL's PASS OCT Spinal System In accordance with 21 CFR 807.92 of the Code of Federal Requlations the following 510(k) summary is submitted to add additional rods to PASS OCT Spinal System and also to get expansion of indications to include posterior cervical screw use. Date Prepared: 02 October 2015 # 1. Submitter: # Contact Person: MEDICREA INTERNATIONAL S.A. 14 Porte du Grand Lyon NEYRON 01700 FR Jean- Denys MARECHAL MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FR Phone Number: 00 33 4 72 81 87 87 #### 2. Trade name: PASS OCT Spinal System # Regulatory Identification/Classification: Orthosis, Cervical pedicle screw spinal fixation Product code: NKG Unclassified, Pre-Amendment Spinal Interlaminal Fixation Orthosis Regulation Number: 21 CFR 888.3050 Product Code: KWP Class II #### 3. Predicate or legally marketed devices which are substantially equivalent: # Primary predicate: - Vertex Reconstruction System, (MEDTRONIC SOFAMOR DANEK USA; K143471) . Additional predicates: - Virage OCT Spinal Fixation System; (ZIMMER SPINE, K133556) ● - . PASS OCT Spinal System, (MEDICREA INTERNATIONAL, K121979) No reference devices were used in this submission. {4}------------------------------------------------ # 4. Description of the device: The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations. The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications. # 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. MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F136-11 & ISO 5832-30; CP Titanium according to the ASTM F67 and ISO 5832-2; PEEK OPTIMA LT1® according to the ASTM F2026-10 and cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO5832-12 and ASTM F1537. Function: The PASS OCT spinal system was developed as an implant: - · To provide immobilization and stabilization of posterior spinal segments - · to auqment the development of a solid spinal fusion - to provide stability to ease fusion - to be mechanically resistant to allow the fusion of the operated level # 5. Indication for Use The PASS OCT Spinal System is intended to provide immobilization of spinal seqments 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 from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 PASS OCT Spinal System 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 to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT Spinal System may be connected to the PASS LP Spinal System rods with the dual diameter rods. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use. # 6. Substantial equivalence claimed to predicate devices The PASS OCT Spinal system components are technologically similar to the already cleared PASS OCT Spinal System Components, Vertex Reconstruction System Components and Synapse {5}------------------------------------------------ Occipital Cervical Thoracic Components in terms of intended use, materials used, mechanical safety and performances - PASS OCT Spinal System, (MEDICREA INTERNATIONAL, K121979) . - . Vertex Reconstruction System, (MEDTRONIC SOFAMOR DANEK USA; K143471) - Virage OCT Spinal Fixation System; (ZIMMER SPINE, K133556) . The table below compares the features and characteristics of PASS OCT components to their predicate devices. | Device | MEDICREA INTERNATIONAL PASS OCT Spinal System NEW COMPONENT | MEDTRONIC SOFAMOR DANEK Vertex Reconstruction System | ZIMMER SPINE Virage OCT Spinal Fixation System | MEDICREA INTERNATIONAL PASS OCT Spinal System | |--------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------| | 510(k) number | Unknown | K143471 | K133556 | K121979 | | Intended use | | | | | | Occipital | Yes | Yes | Yes | Yes | | Cervical | Yes | Yes | Yes | Yes | | Thoracic | Yes | Yes | Yes | Yes | | Components | | | | | | Anchorage means | - Polyaxial screws - Polyaxial hooks - Occipital bone screws | - Multi-axial screws - Hooks - Occipital bone screws | - Polyaxial Screws - Hooks - Occipital bone screws | - Polyaxial screws - Polyaxial hooks - Occipital bone screws | | Rods diameter | Ø3.5 mm | Ø3.5mm and Ø3.2mm | Ø3.5mm | Ø3.5 mm | | Straight rods | Yes | Yes | Yes | Yes | | Pre-bent rods | Yes | Yes | Yes | No | | Materials | | | | | {6}------------------------------------------------ | Device | MEDICREA INTERNATIONAL PASS OCT Spinal System NEW COMPONENT | MEDTRONIC SOFAMOR DANEK Vertex Reconstruction System | ZIMMER SPINE Virage OCT Spinal Fixation System | MEDICREA INTERNATIONAL PASS OCT Spinal System | |--------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | | Titanium Alloy (Ti-6Al-4V) according to ASTM F136 & ISO 5832-3 | Titanium Alloy (Ti- 6Al-4V) according to ASTM F136 & ISO 5832-3 | Ti-6Al-4V (ASTM F136) Or Co-Cr 28Mo6 alloy 1 (following the ASTMF1537) | Titanium Alloy (Ti- 6Al-4V) according to ASTM F136 & ISO 5832-3 | | | -Grade Titanium according to ASTM F67-13 & ISO 5832-2 PEEK OPTIMA LT1 conforming to ASTM F2026 | - Grade Titanium according to ASTM F67 & ISO 5832-2 - Shape Memory Alloy (Nitinol-NiTi) according to ASTM F2063 | | PEEK OPTIMA LT1 conforming to ASTM F2026 | | | Co-Cr 28Mo6 alloy 1 (following the ASTMF1537) | | | | # 7. Non-clinical Test Summary: The components of the PASS OCT spinal were mechanically evaluated in dynamic compression tests following the ASTM F2706-08. # 8. Clinical Test Summary Published literature was used to demonstrate substantial equivalence. # 9. Conclusions Non clinical and Clinical The PASS OCT Spinal System are substantially equivalent to legally marketed predicate device.