(260 days)
No
The device description and intended use focus on the physical characteristics and surgical application of an intervertebral cage made of PEEK and titanium markers. 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 data analysis or prediction.
Yes
The device is indicated for intervertebral body fusion in patients with degenerative disc disease, which involves treating a medical condition to restore function.
No
Explanation: The device is an intervertebral body fusion cage designed for treatment (fusion) of degenerative disc disease, not for diagnosing conditions.
No
The device description clearly states that the device is a physical implantable cage made of PEEK and titanium, and is used with surgical instruments. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical cage made of PEEK and titanium, designed to be implanted in the spine. This is consistent with a surgical implant.
- 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.
- Performance Studies: The performance studies described are mechanical tests (compression, shear, torsion, subsidence, expulsion) which are relevant to the structural integrity and function of a surgical implant, not the diagnostic accuracy of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SYNSTER CERVICAL CAGE is 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 is 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 device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 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)
MAX, ODP
Device Description
The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and 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], 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 components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. 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) CAGE is implanted by using the (SCCI, SACI, SPCI, SPTCI and STCI) instruments 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:
- Static and dynamic compression testing, static compression shear testing, conducted in accordance with ASTM F2077-03
- Static and dynamic torsion testing, conducted in accordance with ASTM -F2077-03
- Subsidence testing, conducted in accordance with ASTM F2267-04 -
- Expulsion testing (per ASTM Draft Standard F 04.25.02.02) -
Tests performed according to ASTM F2077/F2267 indicate that The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE meet required mechanical strengths. Some of the predicate devices have a different geometry than The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE. But the non-clinical mechanical test results demonstrate that any minor differences do not impact performance as compared to the predicates and demonstrate that The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE is substantially equivalent to the predicate device.
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.
Eminent Spine Interbody Fusion System (K090064)
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.
Genesys Spine Interbody Fusion System (K103034), BAK/Cervical Interbody Fusion System (P980048), Affinity Anterior Cervical Cage System (P000028), RAY Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), INTERFIX Threaded Fusion Device (P970015), RABEATM Spinal Implant (K082848), Aesculap PEEK Spinal Implant System (K071983), Stryker Spine AVS® TL PEEK Spacers (K083661), Synthes T-PAL Spacer (K100089), AVS® PL PEEK Spacers (K093704), AnyPlus ALIF, PLIF, TLIF PEEK Lumbar Cage (K100516)
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/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. The text "BMK Global Medical Company" is displayed in bold, with the "R" in a circle indicating a registered trademark.
MAR 1 4 2012
510(k) Summary
The following 510(k) summary is submitted as required by 21 CFR Part 807.92:
Date Prepared: Feb 21, 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 |
2. Device Identification:
Trade Name: SYNSTER® CERVICAL CAGE
SYNSTER® ALIF CAGE SYNSTER® PLIF CAGE SYNSTER® PTLIF CAGE SYNSTER® 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
(21 CFR 880.3080, Product Code MAX)
-
- Identification of the Legally Marketed Devices (Predicate):
Substantial Equivalence for the SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and 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:
- Identification of the Legally Marketed Devices (Predicate):
Eminent Spine Interbody Fusion System (K090064) Genesys Spine Interbody Fusion System (K103034)
1
Image /page/1/Picture/1 description: The image contains the logo for BMK Global Medical Company. On the left side of the logo is a circular emblem with a stylized human figure inside a globe. To the right of the emblem is the text "BMK" in large, bold letters, with the words "Global Medical Company" underneath in a smaller font.
BAK/Cervical Interbody Fusion System (P980048) Affinity Anterior Cervical Cage System (P000028) RAY Threaded Fusion Cage (P950019) Lumbar I/F Cage (P960025) INTERFIX Threaded Fusion Device (P970015) RABEATM Spinal Implant (K082848) Aesculap PEEK Spinal Implant System (K071983) Stryker Spine AVS® TL PEEK Spacers (K083661) Synthes T-PAL Spacer (K100089) AVS® PL PEEK Spacers (K093704) AnyPlus ALIF, PLIF, TLIF PEEK Lumbar Cage (K100516)
4. Device Description:
The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and 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], 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 components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. 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) CAGE is implanted by using the (SCCI, SACI, SPCI, SPTCI and STCI) instruments manufactured from stainless steel materials that conform to ASTM F899.
5. Indications for Use:
The SYNSTER CERVICAL CAGE is 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 is 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 device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic
2
Image /page/2/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 arms outstretched inside a globe. The text "BMK Global Medical Company" is written in bold, black letters, with the letters "BMK" being larger than the rest of the text.
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.
6. Summary of Technology Characteristics:
The purpose of this premarket notification is to obtain clearance to market the SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE. The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.
The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE Implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device.
The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion;
- Intended for use at one level from the C2-C3 disc to the C7-T1 disc for the । treatment degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at the involved level.
- Intended for use at either one level or two contiguous levels from L2-S1 for । the treatment of degenerative disc disease (DDD) with up Grade I spondylolisthesis or retrolisthesis at the involved level(s).
- Substantially equivalent result of non-clinical testing relative static and dynamic testing (per ASTM F2077-03), subsidence testing (per ASTM F2267-04), and expulsion testing (per ASTM Draft Standard F 04.25.02.02)
7. Discussion of Non-clinical Testing
The following non-clinical tests were conducted:
- Static and dynamic compression testing, static compression shear testing, conducted in accordance with ASTM F2077-03
- Static and dynamic torsion testing, conducted in accordance with ASTM -F2077-03
- Subsidence testing, conducted in accordance with ASTM F2267-04 -
- Expulsion testing (per ASTM Draft Standard F 04.25.02.02) -
8. Conclusions
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. Tests performed according to ASTM F2077/F2267 indicate that The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE meet required mechanical strengths. Some of the predicate devices have a different geometry than The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE. But the non-clinical mechanical test results demonstrate that any minor differences do not impact performance as compared to the predicates and demonstrate that The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. 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 CO., LTD. % LK Consulting Group Ms. Priscilla Chung 951 Starbuck Street, Unit J Fullerton, California 92833
Re: K111820
Trade/Device Name: SYNSTER® CERVICAL CAGE SYNSTER® ALIF CAGE SYNSTER® PLIF CAGE SYNSTER® PTLIF CAGE SYNSTER® TLIF CAGE Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: March 1, 2012 Received: March 8, 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 I va may, more 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 r touse be advised a determination that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must
MAR 1 4 2012
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.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 I ou may 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 yours,
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
K111820 510(k) Number (if known)
Device Name: SYNSTER® CERVICAL CAGE SYNSTER® ALIF CAGE SYNSTER® PLIF CAGE SYNSTER® PTLIF CAGE SYNSTER® TLIF CAGE .
Indications for Use:
The SYNSTER CERVICAL CAGE is 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 is 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 device is 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 >