(182 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of the interbody fusion cages, with no mention of AI or ML technology.
Yes
The device is an intervertebral body fusion system designed to treat degenerative disc disease and facilitate fusion, which directly addresses a medical condition.
No
This device is an intervertebral body fusion cage and is used for treatment (fusion) rather than diagnosis. The mention of "radiographic studies" is for confirming the condition, not as an input for the device's function.
No
The device description explicitly states that the device components are made of PEEK and titanium, and are implanted using stainless steel instruments. This indicates a physical, implantable medical device, not a software-only device.
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 (intervertebral body fusion cage) used to treat degenerative disc disease in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and configurations of a physical implant designed to be placed within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on mechanical properties, sterility, and shelf life, which are relevant to a surgical implant, not an IVD.
In vitro diagnostics are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The SYNSTER® CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The devices are intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:
- Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
- Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF, and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE], which may be implanted
- As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach;
- Bi-laterally via a posterior (PLIF) approach;
- As a single device via a posterior transforaminal (PTLIF) approach;
- As a single device via a transforaminal (TLIF) approach.
The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE components are made of polyether ether ketone (PEEK OPTIMA® LT1) that conforms to ASTM F2026, and is supplied as nonsterile and/or gamma sterile. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device. The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF, RHEA® PLIF CAGE and TALON® TLIF CAGE are implanted by using the instruments specially designed and manufactured from stainless steel materials that conform to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C3 disc to the C7-T1 disc), lumbar spine (L2 to S1)
Indicated Patient Age Range
skeletally mature patients
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)
The following non-clinical tests were conducted:
- Sterility test (ISO 11737-1)
- Shelf Life Validation Test
- Mechanical and Physical Studies on gamma-sterilized PEEK-OPTIMA
- Mechanical Testing in accordance with ASTM F2077-03 and ASTM F2267-04 for TALON® TLIF CAGE
- Static axial compression testing
- Static torsion testing
- Static compression-shear testing
- Dynamic axial compression testing
- Subsidence testing
Results from the studies demonstrate that the subject devices are substantially equivalent to the referenced predicates.
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.
K111820, K090064, K093704, K110650, K100516, K103034
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for BMK Global Medical Company. The logo consists of two parts: a circular graphic on the left and the company name on the right. The circular graphic features a human figure with outstretched arms inside a globe. The text "BMK Global Medical Company" is displayed in bold, black letters.
510(k) Summary
FEB 1 5 2013
The following 510(k) summary is submitted as required by 21 CFR Part 807.92: Date Prepared: January 23, 2013
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 |
2. Purpose of Submission
The purpose of this Special 510(k) is to add gamma sterilized models and additional new design models to the unmodified device (SYNSTER cages, K111820). The intended use and the principal technology of the subject device are the same as the unmodified device.
-
The added sterilized models have the same design as the unmodified device.
-
The additional new design models have trivial design and dimension modifications comparing to the unmodified device.
3. Device Identification:
Trade Name: SYNSTER® CERVICAL CAGE
SYNSTER® ALIF CAGE
SYNSTER® PLIF CAGE
SYNSTER® PTLIF CAGE
SYNSTER® TLIF CAGE
RHEA® PLIF CAGE
TALON® TLIF CAGE
Common Name: Intervertebral Body Fusion Device
Classification Name: Intervertebral Fusion Device with Bone Graft, Cervical
(21 CFR 880.3080, Product Code ODP)
Intervertebral Fusion Device with Bone Graft, Lumbar
1
Image /page/1/Picture/0 description: The image shows the logo for BMK Global Medical Company. The logo consists of a circle with a human figure inside, and the text "BMK Global Medical Company" to the right. The letters BMK are in a larger font than the rest of the text. There is a registered trademark symbol next to the K.
(21 CFR 880.3080, Product Code MAX)
4. Identification of the Legally Marketed Devices (Predicate):
Substantial Equivalence for the SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE 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 following:
- · SYNSTER CERVICAL, ALIF, PLIF, PTLIF and TLIF CAGE (K111820)
- · Eminent Spine Interbody Fusion System (K090064)
- · AVS PL PEEK Spacer System (K093704)
- · Zyston Curve Interbody Spacer System (K110650)
- · AnyPlus ALIF, PLIF, and TLIF PEEK Lumbar Cage (K100516)
- · Genesys Spine Interbody Fusion System (K103034)
5. Device Description: ·
The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:
-
- Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
-
- Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF, and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE], which may be implanted
- As a single device via an Anterior or Anterolateral or Lateral (ALIF) । approach;
- ー Bi-laterally via a posterior (PLIF) approach;
- ー As a single device via a posterior transforaminal (PTLIF) approach;
- ー As a single device via a transforaminal (TLIF) approach.
The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE components are made of polyether ether ketone (PEEK OPTIMA® LT1) that conforms to ASTM F2026, and is supplied as nonsterile and/or gamma sterile. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device. The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF, RHEA® PLIF CAGE and TALON® TLIF CAGE are implanted by using the instruments specially designed and manufactured from stainless steel materials that conform to ASTM F899.
6. Indications for Use:
The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc
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 inside a circle, while the company name is written in bold letters with the words "Global Medical Company" underneath.
confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The SYNSTER (ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1. in skeletally mature patients who have had six months of nonoperative treatment. The devices are intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
7. Summary of Technology Characteristics:
The subject system possesses the same technological characteristics as the predicates. These include similar heights, widths, lengths, and intended use.
8. Discussion of Non-clinical Testing
The following non-clinical tests were conducted:
- Sterility test (ISO 11737-1) -
- -Shelf Life Validation Test
- Mechanical and Physical Studies on gamma-sterilized PEEK-OPTIMA
- Mechanical Testing in accordance with ASTM F2077-03 and ASTM F2267-04 for TALON® TLIF CAGE
- Static axial compression testing 트
- Static torsion testing
- 트 Static compression-shear testing
- Dynamic axial compression testing ■
- l Subsidence testing
9. Conclusions
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical testing mentioned above has been conducted to validate that the modifications do not raise issues of safety and performance. Results from the studies demonstrate that the subject devices are substantially equivalent to the referenced predicates.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the symbol, indicating the department's name and national affiliation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Letter dated: February 15, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BM KOREA Co., Ltd. % LK Consulting Group USA, Incorporated Ms. Priscilla Chung Regulatory Affairs Consultant 951 Starbuck Street, Unit J
Re: K122518
Fullerton, California 92833
Trade/Device Name: SYNSTER® CERVICAL CAGE, SYNSTER® ALIF CAGE, SYNSTER® PLIF CAGE, SYNSTER® PTLIF CAGE, SYNSTER® TLIF CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE
Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: January 29, 2013 Received: January 30, 2013
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 or any Federal statutes and regulations administered by other Federal agencies. You must
4
Page 2 - Ms. Priscilla Chung
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.goy/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Niji Melkerson
Mark N. Melkerson Director . Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K122518 510(k) Number (if known)
Device Name: SYNSTER CERVICAL CAGE, SYNSTER ALIF CAGE, PLIF CAGE, SYNSTER PTLIF CAGE, SYNSTER TLIF CAGE, RHEA PLIF CAGE SYNSTER and TALON TLIF CAGE
Indications for Use:
The SYNSTER® CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The devices are intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
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)
Stephanie Bechtold -S
(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K122518