(96 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system composed of screws, hooks, rods, and other components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is a pedicle screw fixation system intended to treat various spinal instabilities and deformities, which falls under the definition of a therapeutic device.
No
This device is a spinal fixation system, intended to immobilize spinal segments as an adjunct to fusion. Its purpose is to treat various spinal conditions by providing structural support, not to diagnose them.
No
The device description explicitly states it is composed of screws, hooks, rods, plates, cross links, connection and locking devices, which are all hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as being composed of screws, hooks, rods, plates, etc., made of titanium and cobalt-chromium alloys. These are physical implants used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
- Anatomical Site: The device is used directly on the spine within the patient's body. IVDs are used on samples taken from the body.
Therefore, the PASS LP™ Spinal System and the CD Horizon™ Spinal System are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediative patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LPTM Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ Spinal System without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWQ
Device Description
PASS LP™ Spinal System
The PASS LP" Spinal System is composed of screws, hooks, rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, with the exception of the rods intended for in situ bending which are manufactured in non-alloyed titanium (CP titanium) conforming to ISO 5832-2 specifications and ASTM F67 specifications.
CoCr rods and implants are manufactured in Cobalt-Chromium Molybdenum alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. Under no circumstances are the implants reusable.
CD Horizon™ Spinal System
The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this submission following:
- introduce new PASS LP™ Spinal System 'Universal Crosslinks' components
- expand use of the previously cleared CD Horizon™ Spinal System rods with the subject PASS LP™ Universal Crosslinks
- expand use of previously cleared CD Horizon™ Spinal System hooks with previously cleared PASS LP™ Spinal System components
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; non-cervical spine (T1-S1); lumbosacral spine (L2 – S1)
Indicated Patient Age Range
skeletally mature patients, pediatric patients, adolescent
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was conducted in accordance with ASTM F1717. The performance testing demonstrates mechanical equivalence of the subject PASS LP™ universal crosslinks when used with the CD Horizon™ 5.5/6.0 Spinal System.
The mechanical testing (e.g., dynamic compression bending) and an engineering analysis were performed to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K080099, K202771, K141398, K190376, K140738, K150178, K132471
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo features the FDA acronym in bold, blue letters, accompanied by the full name of the agency, "U.S. FOOD & DRUG ADMINISTRATION," in smaller text. To the left of the text is a symbol, possibly representing a staff.
January 5, 2022
Medicrea International SA Karine Trogneux Regulatory Affairs Manager 5389 Route De Strasbourg - Vancia Rillieux-La-Pape, 69140 France
Re: K213281
Trade/Device Name: PASS LP™ Spinal System, CD Horizon™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: September 30, 2021 Received: October 1, 2021
Dear Karine Trogneux:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213281
Device Name PASS LP™ SPINAL SYSTEM
Indications for Use (Describe)
The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediative patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LPTM Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
| 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
Indications for Use
510(k) Number (if known) K213281
Device Name CD Horizon™ Spinal System
Indications for Use (Describe)
The CD Horizon™ Spinal System without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for
indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following
conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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."
5
510(k) SUMMARY
Date Prepared: January 5, 2022
1. Submitter:
MEDICREA INTERNATIONAL (Medtronic) 5389 route de Strasbourg – Vancia RILLIEUX-LA-PAPE 69140 FR
Contact Person:
Karine Trogneux MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR
-
- Trade name: PASS LP™ Spinal System CD Horizon™ Spinal System Regulatory Identification/ Classification
PASS LP™ Spinal System Thoracolumbosacral pedicle screw system Regulation Number: 21CFR 888.3070 Product Code: NKB, KWP Class II
- Trade name: PASS LP™ Spinal System CD Horizon™ Spinal System Regulatory Identification/ Classification
CD Horizon™ Spinal System Thoracolumbosacral pedicle screw system Regulation Number: 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Product Code: NKB, KWP, KWQ Class II
-
- Predicate or legally marketed devices which are substantially equivalent:
Primary predicate for PASS LP™ Spinal System:
- PASS LP™ Spinal System (K080099, S.E. 09/04/2008) .
Primary predicate for CD Horizon™ Spinal System
- CD Horizon™ Spinal System (K202771, S.E. 10/19/2021) .
Additional predicate device:
- PASS LP™ Spinal System (K141398, S.E. 01/09/2015) ●
- PASS LP™ Spinal System (K190376, S.E. 05/02/2019) ●
- PASS LP™ Spinal System (K140738, S.E. 11/04/2014) ●
- . CD Horizon™ Spinal System (K150178, S.E. 02/11/2015)
- CD Horizon™ Spinal System (K132471, S.E. 10/08/2013) ●
The predicates have not been subject to a design related recall.
4. Description of the device:
6
PASS LP™ Spinal System
The PASS LP" Spinal System is composed of screws, hooks, rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, with the exception of the rods intended for in situ bending which are manufactured in non-alloyed titanium (CP titanium) conforming to ISO 5832-2 specifications and ASTM F67 specifications.
CoCr rods and implants are manufactured in Cobalt-Chromium Molybdenum alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. Under no circumstances are the implants reusable.
CD Horizon™ Spinal System
The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this submission following:
- introduce new PASS LP™ Spinal System 'Universal Crosslinks' components
- expand use of the previously cleared CD Horizon™ Spinal System rods with the subject PASS LP™ Universal Crosslinks
- expand use of previously cleared CD Horizon™ Spinal System hooks with previously cleared PASS LP™ Spinal System components
5. Indication for Use
PASS LP™ Spinal System
The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or
7
curvature (e.g., scoliosis, kyphosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates and caps for sacral plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma. The PASS LP™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
CD Horizon™ Spinal System
The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, noncervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the
8
lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications.
6. Comparison of the Technological Characteristics with the Predicate Device
The subject PASS LP™ Spinal System 'Universal Crosslinks' components are technologically similar to the already cleared predicate PASS LP™ Spinal System components (K080099, K141398 and K190376) in terms of fundamental scientific technology, intended use, indication for use, material used and levels of attachment.
When subject PASS LP™ Universal Crosslink and the existing CD Horizon™ Spinal System components, are used together, there is no change to the fundamental scientific technology, indications for use, intended use, materials, and levels of attachment in comparison to the predicates CD Horizon™ Spinal System (K202771) and PASS LP™ Spinal System (K080099, K141398, K190376).
When existing PASS LP™ components and the existing CD Horizon™ Spinal System components, are used together, there is no change to the fundamental scientific technology, indications for use, intended use, materials, and levels of attachment in comparison to the predicates CD Horizon™ Spinal System (K202771, K150178, K132471) and PASS LP™ Spinal System (K141398, K190376).
7. Non-clinical Test Summary:
In accordance with the Guidance for Industry and FDA Staff – Spinal System 510(k)'s, Medicrea has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Mechanical testing was conducted in accordance with ASTM F1717. The performance testing demonstrates mechanical equivalence of the subject PASS LP™ universal crosslinks when used with the CD Horizon™ 5.5/6.0 Spinal System.
9
The mechanical testing (e.g., dynamic compression bending) and an engineering analysis were performed to demonstrate substantial equivalence.
8. Conclusions
The PASS LP™ Spinal System components and CD Horizon™ components have shown through supporting information provided in this premarket notification to be substantially equivalent to the identified predicate devices.