(16 days)
Not Found
No
The document describes intervertebral body fusion systems made of titanium or PEEK, intended for surgical implantation. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The performance studies listed are mechanical tests of the device's physical properties.
Yes
The device is an intervertebral body fusion system, which is a type of implant designed to promote fusion between vertebrae, alleviate pain, and stabilize the spine in patients with disc degeneration and/or spinal instability. These functions clearly indicate a therapeutic purpose.
No
The device is an intervertebral body fusion system, intended for surgical implantation to facilitate spinal fusion, not to diagnose medical conditions. Its use is based on pre-existing diagnoses confirmed by imaging studies.
No
The device description clearly states that the devices are physical implants made from titanium or PEEK with tantalum markers, intended for surgical implantation. It also mentions associated instruments. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The descriptions clearly state that the Peridot-PT and Peridot-TD systems are implants intended for surgical procedures to fuse vertebrae in the spine. They are physical devices inserted into the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze biological specimens. Its function is structural support and facilitating bone fusion.
Therefore, the Peridot-PT and Peridot-TD systems fall under the category of implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Peridot-PT Anterior Cervical Intervertebral body fusion System
The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Perior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment.
The Peridot-PT Anterior Cervical body fusion system is designed for use with autogenous and or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Peridot-PT Intervertebral body fusion system
The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Peridot-TD Anterior Cervical Intervertebral body fusion system
The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
These patients should have had at least six weeks of nonoperative treatment.
The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Peridot-TD Intervertebral body fusion system
The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fussion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
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)
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
4-1) Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.
The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft comprised of Cancellous and/or corticocancellous bone graft.
The hyperlordotic lumbar cages (>20 degree) the form of supplement fixation should be an anterior plate system.
4-2) The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system
This product is intervertebral fusion device manufactured from poly-ether-ether -ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The implants have a 0.5 ~ 1.0 micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cage holders are made of titanium alloy as per ASTM F136. The device have a central canal for receiving autogenous bone graft and offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. Designed to treat cervical and lumbar degenerative disc disease, the platform consists of Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. Tantalum marker on the cage permits the identification of cage position and allows post-operative assessment. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are intended to be used with supplement spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system. The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
C2-T1, L2-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)
- Peridot-PT Anterior Cervical Intervertebral body fusion System
- Static Compression : ASTM F2077 -
- -Static Compression - shear : ASTM F2077
- -Static Torsion : ASTM F2077
- Fatigue Compression : ASTM F2077 -
- Fatigue Compression shear : ASTM F2077 -
- Fatigue Torsion : ASTM F2077 -
- -Subsidence : ASTM F2267
- Peridot-PT Intervertebral body fusion system
- -Static Compression : ASTM F2077
- Static Compression Shear : ASTM F2077 -
- -Fatigue Compression : ASTM F2077
- Fatique Compression Shear : ASTM F2077 -
- Subsidence : ASTM F2267 -
- The Peridot-TD Anterior Cervical Intervertebral body fusion system
- -Static Compression (ASTM F2077)
- Static Torsion (ASTM F2077) -
- Fatigue Compression (ASTM F2077) -
- Fatique Torsion (ASTM F2077) -
- Subsidence (ASTM F2267) -
- Static Tensile (ASTM F1147) -
- Static Shear (ASTM F1044) -
- Fatigue Shear (ASTM F1160) -
- Wear (ASTM F1978) -
- The Peridot-TD Intervertebral body fusion system
- Static Compression (ASTM F2077) -
- Static Compression-shear (ASTM F2077) -
- Fatigue Compression (ASTM F2077) -
- Fatigue Compression-shear (ASTM F2077) -
- Subsidence (ASTM F2267) -
- Static Tensile (ASTM F1147) -
- Static Shear (ASTM F1044) -
- Fatigue Shear (ASTM F1160) -
- Wear (ASTM F1978) -
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
§ 888.3080 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 20, 2023
GBS Commonwealth Co., Ltd. Sungji Yoon RA C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu, Seoul 08507 South Korea
Re: K233839
Trade/Device Name: Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: December 4, 2023 Received: December 4, 2023
Dear Sungji Yoon:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices
2
OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233839
Device Name
Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridor-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
Indications for Use (Describe)
Peridot-PT Anterior Cervical Intervertebral body fusion System
The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Perior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment.
The Peridot-PT Anterior Cervical body fusion system is designed for use with autogenous and or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Peridot-PT Intervertebral body fusion system
The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Peridot-TD Anterior Cervical Intervertebral body fusion system
The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
These patients should have had at least six weeks of nonoperative treatment.
The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Peridot-TD Intervertebral body fusion system
The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fussion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
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)
4
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Image /page/5/Picture/0 description: The image shows the text "K233839" at the top, followed by the logo for GBS Commonwealth. The GBS logo is in a bold, sans-serif font and is colored in a dark purple. The word "COMMONWEALTH" is written in a smaller font size below the GBS logo.
SUMMARY
The following summary is being submitted as required by 21 CFR 807.92(a):
Device Identification 1.
| Submitter: | GBS Commonwealth Co., Ltd. |
|---|---|
| #C-309, 168 Gasan Digital 1-ro, Geumcheon-Gu Seoul, | |
| South Korea | |
| Phone. 82-2-6925-4469 | |
| e-mail: lily.yoon@gbscommonwealth.com | |
| Contact Person: | Lily yoon |
| Date prepared | December, 14, 2023 |
| Trade Name | Peridot-PT Anterior Cervical Intervertebral body
fusion System, Peridot-PT Intervertebral body
fusion system, The Peridot-TD Intervertebral body
fusion system, The Peridot-TD Anterior Cervical
Intervertebral body fusion system |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class | Class II |
| Classification Name | Intervertebral body fusion device
(21 CFR 888.3080) |
| Panel | Orthopedic |
| Product Code | ODP, MAX |
Purpose of 510(k) 2.
The GBS Commonwealth Co. Ltd., here by submits this submission: for product Introduction of The subject device has the same previously cleared K233084 and K232822. All processes are the same. The subject devices want to combine different numbers (K232822 and K233084).
-
- Predicate or legally marketed devices which are substantially equivalent
Primary Predicate Device : K232822 Peridot-TD Spacer system (The Peridot-TD
- Predicate or legally marketed devices which are substantially equivalent
Intervertebral body fusion system), Anterior cervical
Page 1 of 6
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Image /page/6/Picture/0 description: The image shows the logo for GBS Commonwealth. The logo is in a dark blue color and has the letters GBS in large font. Below the letters is the word Commonwealth in a smaller font. The image also has the number K233839 at the top.
interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)/ GBS Commonwealth
Additional Predicate Device : K233084 Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system)/ GBS Commonwealth
Description of the Device 4.
4-1) Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.
The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft comprised of Cancellous and/or corticocancellous bone graft.
The hyperlordotic lumbar cages (>20 degree) the form of supplement fixation
7
Image /page/7/Picture/0 description: The image shows the text "K233839" at the top. Below that is the logo for GBS Commonwealth. The logo is purple and has the letters GBS in large font. Below that is the word "COMMONWEALTH" in a smaller font.
should be an anterior plate system.
4-2) The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system
This product is intervertebral fusion device manufactured from poly-ether-ether -ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The implants have a 0.5 ~ 1.0 micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cage holders are made of titanium alloy as per ASTM F136. The device have a central canal for receiving autogenous bone graft and offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. Designed to treat cervical and lumbar degenerative disc disease, the platform consists of Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. Tantalum marker on the cage permits the identification of cage position and allows post-operative assessment. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are intended to be used with supplement spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system. The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.
5. Indication for Use
5-1) Peridot-PT Anterior Cervical Intervertebral body fusion System The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for
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Image /page/8/Picture/0 description: The image shows the text "K233839" at the top, followed by a logo for GBS Commonwealth. The GBS logo is in a dark blue color and has the word "COMMONWEALTH" written below it. The background of the logo is a light gray color.
anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-PT Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
These patients should have had at least six weeks of nonoperative treatment.
The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
5-2) Peridot-PT Intervertebral body fusion system
Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
5-3) The Peridot-TD Anterior Cervical Intervertebral body fusion system The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
9
Image /page/9/Picture/0 description: The image shows the text "K233839" at the top, followed by a logo for GBS Commonwealth. The GBS logo is in a stylized font and is colored in a dark blue or purple hue. The word "COMMONWEALTH" is written in a smaller font size below the GBS letters.
5-4) The Peridot-TD Intervertebral body fusion system
The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Comparison of the technological characteristics of the subject and predicate 6. devices
The subject device has the same previously cleared K233084 and K232822. All processes are the same. The subject device want to combine different numbers (K232822 and K233084).
7. Performance Testing
The worst-case devices were tested.
- Peridot-PT Anterior Cervical Intervertebral body fusion System
- Static Compression : ASTM F2077 -
- -Static Compression - shear : ASTM F2077
- -Static Torsion : ASTM F2077
- Fatigue Compression : ASTM F2077 -
- Fatigue Compression shear : ASTM F2077 -
- Fatigue Torsion : ASTM F2077 -
- -Subsidence : ASTM F2267
- Peridot-PT Intervertebral body fusion system
- -Static Compression : ASTM F2077
- Static Compression Shear : ASTM F2077 -
- -Fatigue Compression : ASTM F2077
10
Image /page/10/Picture/0 description: The image shows the text "K233839" at the top. Below the text is a logo with the letters "GBS" in a large, bold font. Underneath the letters is the word "COMMONWEALTH" in a smaller font. The logo is in a dark blue color.
- Fatique Compression Shear : ASTM F2077 -
- Subsidence : ASTM F2267 -
- The Peridot-TD Anterior Cervical Intervertebral body fusion system
- -Static Compression (ASTM F2077)
- Static Torsion (ASTM F2077) -
- Fatigue Compression (ASTM F2077) -
- Fatique Torsion (ASTM F2077) -
- Subsidence (ASTM F2267) -
- Static Tensile (ASTM F1147) -
- Static Shear (ASTM F1044) -
- Fatigue Shear (ASTM F1160) -
- Wear (ASTM F1978) -
- The Peridot-TD Intervertebral body fusion system
- Static Compression (ASTM F2077) -
- Static Compression-shear (ASTM F2077) -
- Fatigue Compression (ASTM F2077) -
- Fatigue Compression-shear (ASTM F2077) -
- Subsidence (ASTM F2267) -
- Static Tensile (ASTM F1147) -
- Static Shear (ASTM F1044) -
- Fatigue Shear (ASTM F1160) -
- Wear (ASTM F1978) -
8. Conclusion
Based on the information provided in this premarket notification of GBS Commonwealth Co., Ltd. concludes that Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system, The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system are substantially equivalent to predicate devices.