(93 days)
Not Found
No
The 510(k) summary describes a mechanical pedicle screw system and its components. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is indicated for the treatment of severe Spondylolisthesis, immobilization and stabilization of spinal segments, and as an adjunct to fusion for various spinal conditions, all of which are medical treatments.
No
The device is described as a non-cervical pedicle screw system that provides immobilization and stabilization of spinal segments as an adjunct to fusion for treating deformities and instabilities. This indicates it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description explicitly details physical components made of medical-grade titanium alloy (rods, screws, cross links) and describes mechanical testing (static and dynamic compression, tension, torsion) in accordance with ASTM standards, which are relevant to hardware performance. There is no mention of software as the primary or sole component.
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 used to stabilize the spine in skeletally mature patients for various conditions like spondylolisthesis, fracture, scoliosis, etc. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of rods, screws, and cross links made of titanium alloy, designed for surgical implantation. This aligns with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide diagnostic information. The device's function is mechanical stabilization.
Therefore, the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are non-cervical, pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis)
Product codes
MNH, MNI
Device Description
The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw . System are posterior, noncervical, pedicle screw spinal system which consists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case. Please note that certain components are specifically designed to connect to ø 5.5mm or ø 6.0mm rods. Care should be taken so that the correct components are used in the spinal construct. The Pedicle Screw Spinal Fixation System was made out of medical grade titanium alloy described by standard such as ASTM F136. Never use stainless steel and titanium implant components in the same construct.
To achieve best results, do not use any of the Pedicle Screw Spinal Fixation System with components from any other system or manufacturer unless specifically allowed to do so in this. The Pedicle Screw Spinal Fixation System implant will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, L5-S 1 vertebra, lumbar and sacral spine (L3 to sacrum), thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
The follow non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM .' · F1717
- Static tension testing in accordance with ASTM F1717 -
- Static torsion testing, conducted in accordance with ASTM F1717
The data of tests performed according to ASTM F1717 indicate that The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System meet required mechanical strengths based on the predicate comparison. Some of the predicate devices have an insignificantly different geometry than The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System. But the non-clinical mechanical test results demonstrate that the minor differences do not impact performance as compared to the predicates and demonstrate that the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 BMK Global Medical Company. The logo consists of two parts: a circular emblem on the left and the company name on the right. The emblem features a stylized human figure with outstretched arms inside a circle, surrounded by text. To the right of the emblem, the letters "BMK" are displayed in large, bold font, with the words "Global Medical Company" written in a smaller font underneath.
MAY - 9 2012
510(k) Summary
The following 510(k) summary is submitted as required by 21 CFR Part 807.92:
Date Prepared: February 01, 2012
1. Submission information:
| a) Submitter | |
|---|---|
| Name | BM KOREA CO., LTD. |
| Address | 325-26 Dangjeong-dong, Gunpo-si, Gyeonggi-do |
| 435-832 South Korea | |
| Phone | 82-31-451-9294~5 |
| Fax | 82-31-451-9248 |
| Contact | Ju Yun |
b) U.S Agent
| Name | LK Consulting Group |
|---|---|
| Address | 951 Starbuck St. Unit J, |
| Fullerton, CA 92833 | |
| Phone | 714-869-3080 |
| Fax | 714-409-3357 |
| Contact | Priscilla Chung (juhee.c@lkconsultinggroup.com) |
2. Device Identification:
Trade Name: SYNSTER® Pedicle Screw System
SYNSTER® PLUS Pedicle Screw System
Common Name: Pedicle Screw Spinal Fixation System
Classification Name: orthosis, spondylolisthesis spinal fixation (21 CFR 880.3070, Product Code MNH)
orthosis, spinal pedicle fixation (21 CFR 880.3070, Product Code MNI)
3. Identification of the Legally Marketed Devices (Predicate):
Substantial Equivalence for the SYNSTER® Pedicle Screw System and SYNSTER® PLUS Pedicle Screw System is based on its similarities in indications for use, design features, operational principle and material composition when compared to the predicate devices cleared under the follows:
Tyche® Pedicle Screw System (K100373) OPTIMATM Spinal System (K024096) VERTEBRON PSS™ Pedicle Screw System (K043152)
1
Image /page/1/Picture/0 description: The image contains a sequence of handwritten digits. The digits appear to be '1120353'. The numbers are written in black ink on a white background. The handwriting is somewhat stylized.
Image /page/1/Picture/1 description: The image shows the logo for BMK Global Medical Company. On the left is a circular logo with a figure of a person with outstretched arms inside of a globe. To the right of the logo is the text "BMK Global Medical Company" in bold black letters. There is a registered trademark symbol to the right of the letter K.
4. Device Description:
The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw . System are posterior, noncervical, pedicle screw spinal system which consists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case. Please note that certain components are specifically designed to connect to ø 5.5mm or ø 6.0mm rods. Care should be taken so that the correct components are used in the spinal construct. The Pedicle Screw Spinal Fixation System was made out of medical grade titanium alloy described by standard such as ASTM F136. Never use stainless steel and titanium implant components in the same construct.
To achieve best results, do not use any of the Pedicle Screw Spinal Fixation System with components from any other system or manufacturer unless specifically allowed to do so in this. The Pedicle Screw Spinal Fixation System implant will be provided non-sterile.
5. Indications for Use:
The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are non-cervical, pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis)
6. Summary of Technology Characteristics:
The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles. Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate devices and is safe and effective when used as intended.
7. Discussion of Non-clinical Testing
The follow non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM .' · F1717
- Static tension testing in accordance with ASTM F1717 -
- Static torsion testing, conducted in accordance with ASTM F1717
8. Conclusions
The subject and predicate device(s) share the same intended use, design features and material. The data of tests performed according to ASTM F1717 indicate that The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System
2
Image /page/2/Picture/1 description: The image shows the logo for BMK Global Medical Company. The logo consists of two parts: a circular emblem on the left and the company name on the right. The emblem features a stylized human figure with outstretched arms inside a circle, surrounded by text. The company name "BMK Global Medical Company" is displayed in bold, sans-serif font, with the letters "BMK" in a larger size than the rest of the name.
meet required mechanical strengths based on the predicate comparison. Some of the predicate devices have an insignificantly different geometry than The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System. But the non-clinical mechanical test results demonstrate that the minor differences do not impact performance as compared to the predicates and demonstrate that the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BM Korea Company, LTD. % LK Consulting Group Ms. Priscilla Chung Regulatory Affairs Consultant 951 Starbuck Street, Unit J Fullerton, California 92833
MAY - 9 2012
Re: K120353
Trade/Device Name: SYNSTER® Pedicle Screw System SYNSTER® PLUS Pedicle Screw System Regulation Number: 21 CFR 888.3070 · Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: April 6, 2012 Received: April 12, 2012
Dear Ms. Chung:
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
4
Page 2 - Ms. Priscilla Chung
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
incerely yours,
for Peter D/K
$\frac{ma}{m/f}$
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K120353
Device Name: SYNSTER® Pedicle Screw System SYNSTER® PLUS Pedicle Screw System
Indications for Use:
The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are non-cervical, pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis)
Prescription Use_ X (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K
(Div/sion Sign-Off) Difision of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page 1 of 1