Who is the manufacturer of PASS OCT Patient Specific Rods?

Medicrea International filed the 510(k) submission for PASS OCT Patient Specific Rods (K153169).

What is the FDA product code for PASS OCT Patient Specific Rods?

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 Patient Specific Rods?

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

What are the predicate devices for PASS OCT Patient Specific Rods?

PASS OCT Spinal System (K150918).

Who can help prepare an FDA 510(k) submission like PASS OCT Patient Specific Rods?

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 Patient Specific Rods

K153169 · Medicrea International · NKG · Jan 29, 2016 · Orthopedic

Device Facts

Record ID	K153169
Device Name	PASS OCT Patient Specific Rods
Applicant	Medicrea International
Product Code	NKG · Orthopedic
Decision Date	Jan 29, 2016
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 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 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 Patient Specific Rods are spinal fixation components; rods are pre-bent by manufacturer prior to surgery based on patient-specific design defined by surgeon. System includes polyaxial screws, hooks, and occipital plates for posterior spinal stabilization. Used in OR by orthopedic or neurosurgeons to immobilize spinal segments as adjunct to fusion or for temporary stabilization in tumor patients. Rods integrate with existing PASS OCT spinal system components. Pre-bending process aims to match patient anatomy, potentially reducing intraoperative contouring time and improving fit. Device provides mechanical stability to facilitate bone fusion.

Clinical Evidence

No clinical trials were conducted. Substantial equivalence was demonstrated through non-clinical mechanical testing (static and dynamic compression and torsion per ASTM F2706-08) and the use of 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), and Co-Cr-Mo alloy (ASTM F1537/ISO 5832-12). Components include polyaxial screws, hooks, occipital plates, and patient-specific pre-bent rods (3.5mm diameter). System is a posterior spinal fixation construct.

Indications for Use

Indicated for patients requiring immobilization of spinal segments (C1-C7 and T1-T3) due to acute/chronic instabilities, including traumatic fractures/dislocations, instability/deformity, pseudarthrosis, cervical tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for temporary spinal column 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

PASS OCT Spinal System (K150918)

Reference Devices

PASS LP Spinal System - Patient Specific Rods (K140738)

Related Devices

K150918 — PASS OCT Spinal System · Medicrea International SA · Oct 16, 2015
K140738 — PASS LP SPINAL SYSTEM · Medicrea International · Nov 4, 2014
K220810 — Infinity OCT System and PASS OCT Spinal System · Medicrea International · Apr 19, 2022
K210449 — Infinity OCT System, PASS OCT® Spinal System · Medtronic · Mar 18, 2021
K161149 — PASS OCT Spinal System · Medicrea International SA · Jul 11, 2016

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 29, 2016 Medicrea International Mr. David Ryan VP, Product Development and Marketing 14 Porte du Grand Lyon 01700 Nevron FRANCE Re: K153169 Trade/Device Name: PASS OCT Patient Specific Rods Regulatory Class: Unclassified Product Code: NKG, KWP Dated: October 30, 2015 Received: November 2, 2015 Dear Mr. Ryan: 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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 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}------------------------------------------------ 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 below. 510(k) Number (if known) K153169 Device Name PASS OCT Patient Specific Rods 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 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 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) | | |---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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 Patient Specific Rods In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted to add the ranges of Patient Specific Rods to PASS OCT Spinal System. Date Prepared: 30 October 2015 - 1. Submitter: | Submitter: | Contact Person: | |------------------------|------------------------| | MEDICREA INTERNATIONAL | David RYAN | | 14 Porte du Grand Lyon | MEDICREA INTERNATIONAL | | NEYRON 01700 | 14 Porte du Grand Lyon | | | NEYRON 01700 FR | | | Ph +33 4 72 01 87 87 | - 2. Trade name: PASS OCT Patient Specific Rods ### Regulatory Identification/Classification: Orthosis, Cervical Pedicle Screw Spinal Fixation Product Code: NKG Unclassified, Pre-Amendment Spinal Interlaminal Fixation Orthosis Requlation Number: 21CFR 888.3050 Product Code: KWP Class II #### 3. Predicate or leqally marketed devices which are substantially equivalent: #### Primary predicate: PASS OCT Spinal System, (MEDICREA INTERNATIONAL, K150918) . No recall recorded for this product. ### Reference Device: - PASS LP Spinal System - Patient Specific Rods, (MEDICREA INTERNATIONAL, K140738) #### 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. {4}------------------------------------------------ Function: The PASS OCT spinal system was developed as an implant: - · To provide immobilization and stabilization of posterior spinal segments - to augment 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 The purpose of this submission is to add Patient Specific, UNiD OCT rods. The Patient Specific Rod is a rod bent before surgery by MEDICREA, following the design defined by the surgeon only specific to a unique patient. # 5. Indication for 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); turnors 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. #### Substantial equivalence claimed to predicate devices 6. The PASS OCT Patient Specific Rods are technologically similar to the already cleared PASS OCT Spinal System Rods in terms of intended use, materials used, mechanical safety and performances The table below compares the features and characteristics of PASS OCT components to their predicate devices. | Device | MEDICREA INTERNATIONAL (subject device) | MEDICREA INTERNATIONAL PASS OCT Spinal System | |--------------------|-------------------------------------------------------------------|-------------------------------------------------------------------| | 510(k) number | Unknown | K150918 | | Intended use | | | | Occipital | Yes | Yes | | Cervical | Yes | Yes | | Thoracic | Yes | Yes | | Components | | | | Anchorage means | -Polyaxial screws - Polyaxial hooks - Occipital bone screws | -Polyaxial screws - Polyaxial hooks - Occipital bone screws | | Rods diameter | Ø3.5 mm | Ø3.5 mm | | Dual Diameter Rods | Ø3.5mm/ Ø5.5mm Ø3.5mm/ Ø6.0 mm | Ø3.5mm/ Ø5.5mm Ø3.5mm/ Ø6.0 mm | | Straight rods | No | Yes | | Pre-bent rods | No | Yes | {5}------------------------------------------------ | Patient Specific Rods, pre-bent before surgery | Yes | No | |---------------------------------------------------|-----|----| |---------------------------------------------------|-----|----| | Device | MEDICREA INTERNATIONAL (subject device) | MEDICREA INTERNATIONAL PASS OCT Spinal System | |-----------|----------------------------------------------------------------------|----------------------------------------------------------------------| | Materials | | | | | Titanium Alloy (Ti-6Al-4V) according to ASTM F136 & ISO 5832-3 | Titanium Alloy (Ti-6Al-4V) according to ASTM F136 & ISO 5832-3 | | | -Grade Titanium according to ASTM F67-13 & ISO 5832-2 | -Grade Titanium according to ASTM F67-13 & ISO 5832-2 | | | PEEK OPTIMA LT1 conforming to ASTM F2026 | PEEK OPTIMA LT1 conforming to ASTM F2026 | | | Co-Cr 28Mo6 alloy 1 (following the ASTMF1537 | Co-Cr 28Mo6 alloy 1 (following the ASTMF1537 | ### 7. Non-clinical Test Summary: The components of the PASS OCT Patient Specific Rods were mechanically evaluated in static and dynamic compression and static and dynamic torsion tests following the ASTM F2706-08. Each time, the mechanical test was conducted on a justified worst case. #### 8. Clinical Test Summary Published literature was used to demonstrate substantial equivalence # 9. Conclusions Non clinical and Clinical The PASS OCT Patient Specific Rods components are substantially equivalent to legally marketed predicate device.