(361 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and its performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a surgical implant designed for posterior spinal fixation as an adjunct to fusion for a variety of conditions, not for general therapeutic treatment.
No
The device is described as a "Posterior Spinal Fixation System" intended for surgical fixation of the spine as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly states it is a "single-use system for surgical fixation of the spine" made up of "pedicle screws, rods, and interconnecting devices" manufactured from "titanium alloy," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Posterior Spinal Fixation System is a surgical implant used to stabilize the spine. It is made of physical components (screws, rods, etc.) that are surgically inserted into the body.
- Intended Use: The intended use is for posterior spinal fixation as an adjunct to fusion for various spinal conditions. This is a surgical procedure, not a diagnostic test performed on samples outside the body.
The description clearly indicates a device used within the body for structural support and stabilization, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided non-sterile.
The Posterior Spinal Fixation System includes the following sets:
RS8 LEGEND (designed for open surgery) RS8 LONG (designed for minimally invasive surgery)
Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracolumbosacral spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/Hospital
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)
Bench performance testing was completed using the following standards:
ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static Compression: The compressive bending yield load of the subject device is lower than the predicate device. The compressive bending ultimate load of the subject device is higher than the predicate device.
- Dynamic Compression: The subject device experienced more fractures than the predicate device.
- Static Tensile: The tensile bending ultimate load of the subject device is lower than the predicate device.
- Static Torsion: The yield torque and torsional stiffness of the subject device are lower than the predicate device.
ASTM F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants - Axial Gripping Capacity
- Axial Torque Gripping Capacity
- Static A-P
- Dynamic A-P
- Static Transverse
Characterization Testing: The following testing standards were utilized to characterize the materials: ISO 5832-3, ASTM E1409-13, ASTM E1447-09(2016), ASTM E1941-10, ASTM E2371-13, GB/T 5168-2008, GB/T 13810-2007, GB/T 5193-2007.
Biocompatibility Testing: The following testing standards were utilized for biocompatibility test: ISO/IEC 17025-2005, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2012, ISO/TS 21726:2019, ISO 10993-1:2018, ISO 10993-17:2002, ISO 10993-18:2020, ISO 14971:2019, ISO/IEC 17025-2017.
No animal study data is submitted in this 510(k).
No clinical study data is submitted in this 510(k).
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.
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of an eagle, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
June 21, 2021
Shanghai REACH Medical Instrument Co., Ltd Mingsha Ye Registration Manager Building 13, No. 999 Jiangyue Road, Minhang Shanghai, 201112 China
Re: K201737/S001
Trade/Device Name: Posterior Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 24, 2020 Received: June 25, 2020
Dear Mingsha Ye:
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
1
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 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,
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)
Device Name Posterior Spinal Fixation System
Indications for Use (Describe)
The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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); tumor; pseudarthrosis; and/or failed previous fusion.
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
| 510(k) Number: | K201737 | ||
|---|---|---|---|
| Preparation Date: | December 28, 2020 | ||
| Submitter: | Shanghai REACH Medical Instrument Co., Ltd | ||
| Building 13,No.999 Jiangyue Road, Minhang District, 201114 Shanghai, PEOPLE'S | |||
| REPUBLIC OF CHINA | |||
| Establishment Registration Number: 3015487912 | |||
| Primary Contact: | Mingsha Ye, Registration Manager | ||
| Shanghai Reach Medical Instrument Co., Ltd | |||
| Building 13,No.999 Jiangyue Road, Minhang District, 201114 Shanghai, PEOPLE'S | |||
| REPUBLIC OF CHINA | |||
| Email: yems@reach-med.com | |||
| Tel: (86) 021-54840582 | |||
| Fax: (86) 021-54840581 | |||
| Subject Device: | Trade Name | Posterior Spinal Fixation System | |
| Common Name | Thoracolumbosacral Pedicle Screw System | ||
| Regulation Number | 21 CFR 888.3070 | ||
| Classification Name | Thoracolumbosacral Pedicle Screw System | ||
| Regulatory Class | Class II | ||
| Product Codes | NKB | ||
| Regulation Medical Specialty | Orthopedic | ||
| 510(k) Review Panel | Orthopedic | ||
| Predicate Device: | Manufacturer | Medtronic Sofamor Danek USA, Inc. | |
| Trade Name | CD HORIZON® Spinal System | ||
| 510(k) Number | K130646 | ||
| Regulation Number | 21 CFR 888.3070 | ||
| Regulation Name | Thoracolumbosacral Pedicle Screw System | ||
| Regulatory Class | Class II | ||
| Product Codes | NKB, KWP, KWQ, MNH, MNI | ||
| Regulation Medical Specialty | Orthopedic | ||
| 510(k) Review Panel | Orthopedic | ||
| FDA Guidance Documents | The following FDA guidance documents were consulted to prepare this premarket | ||
| notification: | |||
| Guidance for Industry and FDA Staff: Spinal System 510(k)s, issued May 3, 2004 Guidance on Medical Device Patient Labeling, issued April 19, 2001 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016 Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 11, 2014 | |||
| Intended Use / | |||
| Indications for Use | The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as | ||
| an adjunct to fusion for the following indications: degenerative disc disease (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 and/or lordosis); tumor; | |||
| pseudarthrosis; and/or failed previous fusion. | |||
| Device Description | The Posterior Spinal Fixation System is a single-use system for surgical fixation of the | ||
| spine. It is made up of pedicle screws, rods, and interconnecting devices. The | |||
| implanted parts confer stabilization and fusion of two or more spinal segments and are | |||
| to be removed once their stabilizing function is no longer required. The implantable | |||
| devices are manufactured from titanium alloy and are provided non-sterile. | |||
| The Posterior Spinal Fixation System includes the following sets: | |||
| RS8 LEGEND (designed for open surgery) RS8 LONG (designed for minimally invasive surgery) | |||
| Each set comprises of different rods, screws, set screws, and accessory parts, including | |||
| various lengths and diameters of reduction screws. Both sets are designed for internal | |||
| posterior thoracolumbar fixation of the spine. Patient diagnosis and individual | |||
| conditions should be taken into consideration when selecting the surgical option. | |||
| Mechanism of Action | The Posterior Spinal Fixation System is a medical device system for surgical fixation | ||
| of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The | |||
| implanted parts confer stabilization and fusion of two or more spinal segments and are | |||
| to be removed once their stabilizing function is no longer required. | |||
| Applicant | Shanghai REACH Medical Instrument, | ||
| Co., Ltd. | Medtronic Sofamor Danek USA, Inc. | ||
| Device Name | Posterior Spinal Fixation System | CD HORIZON® Spinal System | |
| Intended Use / | |||
| Indications for Use | The Posterior Spinal Fixation System is | ||
| intended for posterior, non-cervical | |||
| fixation as an adjunct to fusion for the | |||
| following indications: degenerative disc | |||
| disease (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 and/or | |||
| lordosis); tumor; pseudarthrosis; and/or | |||
| failed previous fusion. | The CD HORIZON® Spinal System | ||
| with or without SEXTANT® | |||
| instrumentation is intended for posterior, | |||
| non-cervical fixation as an adjunct to | |||
| fusion for the following indications: | |||
| degenerative disc disease (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 | |||
| and/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 may | |||
| also be used for the same indications as | |||
| an adjunct to fusion. | |||
| With the exception of degenerative disc | |||
| disease, the CD HORIZON® | |||
| LEGACY™ 3.5mm rods and the CD | |||
| HORIZON® Spinal System PEEK rods | |||
| and associated components may be used | |||
| for the aforementioned indications in | |||
| skeletally mature patients as an adjunct | |||
| to fusion. The 3.5mm rods may be used | |||
| for the specific pediatric indications | |||
| below. | |||
| When used for posterior non-cervical | |||
| pedicle screw fixation in pediatric | |||
| patients, the CD HORIZON® Spinal | |||
| System implants are indicated as an | |||
| adjunct to fusion to treat adolescent | |||
| idiopathic scoliosis. Additionally, the | |||
| CD HORIZON® Spinal System is | |||
| intended to treat pediatric patients | |||
| diagnosed with the following conditions: | |||
| Spondylolisthesis/spondylolysis and | |||
| fracture caused by tumor and/or trauma. | |||
| These devices are to be used with | |||
| autograft and/or allograft. Pediatric | |||
| pedicle screw fixation is limited to a | |||
| posterior approach. | |||
| 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 |
| |
| | | | supplemental fixation in the following |
| | | | conditions: degenerative disc disease (as |
| | | | previously defined); spondylolisthesis; |
| | | | trauma; and/or tumor. |
| | | | In order to achieve additional levels of |
| | | | fixation, the 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 the |
| | | | VERTEX® indications of use. |
| Patient Population | | Skeletally mature patients;
Pediatric patients | Skeletally mature patients;
Pediatric patients |
| Anatomical Site | | Thoracolumbosacral spine | Thoracolumbosacral spine |
| Mechanism of Action | | The Posterior Spinal Fixation System is a
medical device system for surgical fixation
of the spine. It is made up of pedicle
screws, rods, and interconnecting devices.
The implanted parts confer stabilization
and fusion of two or more spinal segments
and are to be removed once their
stabilizing function is no longer required. | The CD HORIZON® Spinal System
consists of a variety of shapes and sizes
of rods, hooks, screw, 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. |
| Implant Materials | | Titanium alloy (Ti-6Al-4V) | Stainless steel, titanium, titanium alloy,
cobalt-chromium-molybdenum alloy,
PEEK, and/or nitinol |
| Surgical Instrument
Materials | | Stainless steel (17-4 PH)
Silica gel
Polyformaldehyde (POM)
Aluminum alloy | Unknown |
| Coatings/Colorants: | | Components are colored via an anodizing
process. No other coatings or colorants are
added to the device. | Components are colored via an
anodizing process. No other coatings or
colorants are added to the device. |
| Patient Contact | | Implant: Bone and surrounding tissue
Surgical instruments: Bone and
surrounding tissue | Implant: Bone and surrounding tissue
Surgical instruments: Bone and
surrounding tissue |
| Contact Duration | | Implant: Permanent (>30 days)
Surgical instruments: Limited (≤24 hours) | Implant: Permanent (>30 days)
Surgical instruments: Limited (≤24 hours) |
| Provided Sterile? | | Implant: No
Surgical Instruments: No | Implant: No
Surgical Instruments: No |
| Sterilization Method | | The device is provided non-sterile.
Validated manual cleaning and steam
sterilization instructions are provided for
the end user. | The device is provided non-sterile.
Validated manual cleaning and steam
sterilization instructions are provided for
the end user. |
| Single Use | | Implant: Yes
Surgical Instruments: No | Implant: Yes
Surgical Instruments: No |
| Surgical Instruments
Provided | | Yes | Yes |
| Environment of Use | | Healthcare facility/Hospital | Healthcare facility/Hospital |
| Rods | Diameter
Range | 5.5-6.0mm | 3.5-6.0mm |
| | Length
Range | | |
| Set Screws | Diameter
Range | 40-500mm | 500mm |
| | Diameter
Range | 9.5-10mm | 6.0-10mm |
| Crosslinks | Diameter
Range | 5.0-6.0mm | 3.5-6.0mm |
| | Length
Range | 23-80mm | 13-120mm |
| Polyaxial
Reduction
Screws | Diameter
Range | 4.5-7.5mm | 4.0-8.5mm |
| | Length
Range | 25-90mm | 20-115mm |
| MISS
Polyaxial
Reduction
Screws | Diameter
Range | 4.5-10mm | 4.0-8.5mm |
| | Length
Range | 25-110mm | 20-115mm |
| MR Safety and
Compatibility | | Not evaluated | MR conditional |
| Performance - Bench | | The following testing standards were utilized to complete bench performance testing:
ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a
Vertebrectomy Model Static Compression: The compressive bending yield load of the subject device is lower than the predicate device. The compressive bending ultimate load of the subject device is higher than the predicate device. Dynamic Compression: The subject device experienced more fractures than the predicate device. Static Tensile: The tensile bending ultimate load of the subject device is lower than the predicate device. Static Torsion: The yield torque and torsional stiffness of the subject device are lower than the predicate device. ASTM F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants Axial Gripping Capacity Axial Torque Gripping Capacity Static A-P Dynamic A-P Static Transverse | |
4
5
6
7
8
| Characterization Testing | The following testing standards were utilized to characterize the materials: |
|---|---|
| ISO 5832-3 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4- vanadium alloy ASTM E1409-13 Standard Test Method for Determination of Oxygen and Nitrogen in titanium and titanium Alloys by Inert Gas Fusion ASTM E1447-09(2016) Standard Test Method for Determination of Hydrogen in titanium and titanium Alloys by Inert Gas Fusion Thermal Conductivity/Infrared Detection Method ASTM E1941-10 Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis ASTM E2371-13 Standard Test Method for Analysis of titanium and titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma Atomic Emission Spectrometry (Performance-Based Test Methodology) GB/T 5168-2008 Microstructure And Macrostructure Examination For a-β titanium Alloys GB/T 13810-2007 Wrought Titanium and Titanium Alloy for Surgical Implants GB/T 5193-2007 Method of ultrasonic inspection for wrought titanium and titanium alloy products | |
| Biocompatibility Testing | The following testing standards were utilized for biocompatibility test: |
| ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories; ISO 10993-5:2009: Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity; ISO 10993-10:2010: Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization; ISO 10993-11:2017: Biological evaluation of medical devices-Part 11: Tests for Systemic toxicity; ISO 10993-12:2012: Biological evaluation of medical devices-Part 12: Sample preparation and reference materials; ISO/TS 21726:2019: Biological evaluation of medical devices-Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents; ISO 10993-1:2018: Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process; ISO 10993-17:2002: Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances; ISO 10993-18:2020: Biological evaluation of medical devices-Part 18: Chemical characterization of medical device materials within a risk management process; ISO 14971:2019: Medical devices-Application of risk management to medical devices. ISO/IEC 17025-2017: General requirements for the competence of testing and calibration laboratories. | |
| Performance - Animal | No animal study data is submitted in this 510(k). |
| Performance - Clinical | No clinical study data is submitted in this 510(k). |
9
| Substantial Equivalence | The Posterior Spinal Fixation System is substantially equivalent to the predicate device when evaluating intended use and technological characteristics. The subject device has the identical intended use as the predicate device. There are no differences between the subject device and predicate device with respect to intended use. The subject has different indications for use than the predicate device. The subject device and predicate devices are substantially equivalent with only minor differences regarding: Product codes Indications for use Mechanism of action Materials Rods Set screws Crosslinks Polyaxial reduction screws MISS polyaxial reduction screws Bench performance results: static compression, dynamic compression, static tensile, and static torsion These differences do not raise new questions of safety and effectiveness. |
|---|---|
| Conclusion | Non-clinical data demonstrates the Posterior Spinal Fixation System device is substantially equivalent to the predicate device. The subject device is as safe and effective as the predicate device, and will perform as intended. Therefore, SRMIC respectfully requests market clearance for the Posterior Spinal Fixation System. |