Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 22, 2023 GBS Commonwealth Co., Ltd. Jimmy Kim C-309. Woolim Lion's Valley, 168. Gasan Digital 1-ro Geumcheon-gu, Seoul 08507 South Korea Re: K230708 Trade/Device Name: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD) Anterior Cervical 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: March 9, 2023 Received: March 14, 2023 Dear Jimmy Kim: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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Sincerely, # Brent Showalter -S Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230708 #### Device Name Anterior cervical interbody fusion - ACIF (The Period Intervertebral body fusion system), Peridot TD Spacer system (The Peridot-TD Intervertebral body fusion system) #### Indications for Use (Describe) Anterior cervical interbody fusion - ACIF (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. Peridot-TD Spacer system (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 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) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 11pt;"> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> | | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 11pt;"> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo has a white background. # SUMMARY The following summary is being submitted as required by 21 CFR 807.92(a): #### Device Identification 1. | Submitter: | GBS Commonwealth Co., Ltd.<br>#C-309, 168 Gasan Digital 1-ro, Geumcheon-Gu Seoul,<br>South Korea<br>Phone. 82-2-6925-4469<br>e-mail: Jimmy.kim@gbscommonwealth.com | |-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jimmy Kim | | Date prepared | March, 30, 2023 | | Trade Name | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) and Anterior cervical interbody fusion - ACIF (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 | ## 2. Purpose of 510(k) The GBS Commonwealth Co. Ltd., here by submits this submission: for Initial product Introduction of Peridot-TD Spacer system and Anterior Cervical Interbody fusion system #### Predicate or legally marketed devices which are substantially equivalent 3. - Primary Predicate Device : K210497 SeaSpine Spacer System NM, SeaSpine Cambria System - Additional Predicate Device : 1) K213980 Peridot Spinal Interbody System, GBS Commonwealth {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, blue font. Below the letters is the word "COMMONWEALTH" in a smaller, blue font. The logo has a globe-like design in the background. 2) K213755 Peridot-PT Intervertebral fusion system, GBS Commonwealth 3) K200551 MectaLIF Transforaminal TiPEEK, Medacta International SA #### 4. Description of the Device The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cages holders are made of titanium alloy as per ASTM F136. The Peridot-TD Cages 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), Lateral (LLIF), 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 screw and rod system, anterior plate and screw system, or lateral plate and screw system). The implant cages are supplied sterilized. The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation. The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile. ### 5. Indication for Use Anterior cervical interbody fusion - ACIF (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 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, blue font. Below the letters, the word "COMMONWEALTH" is written in a smaller, blue font. The logo is set against a light gray, oval background. 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. 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 allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. ### Peridot-TD Spacer system (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. # 6. Comparison of the technological characteristics of the subject and predicate devices The Peridot-TD Anterior Cervical Interbody fusion and Peridot-TD Spacer System are considered substantially equivalent to the primary predicate SeaSpine Spacer System NM,SeaSpine Cambria System K210497 and additional predicate devices K213980 ,K213755 and K200551. They are similar in design, material, scientific technologies and indications for use. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, blue font at the top of the logo. Below the letters, the word "COMMONWEALTH" is written in a smaller, bold, blue font. The background of the logo is white. ### 7. Performance Testing The worst-case devices were tested. - 1) Anterior cervical interbody fusion ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) - Static Compression (ASTM F2077) - Static Torsion (ASTM F2077) - Fatigue Compression (ASTM F2077) - Fatigue Torsion (ASTM F2077) - Subsidence (ASTM F2267) - Static Tensile (ASTM F1147) - Static Shear (ASTM F1044) - Fatigue Shear (ASTM F1160) - Wear (ASTM F1978) - 2) Peridot-TD Spacer system (The Peridot-TD 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) - 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 Anterior cervical interbody fusion - ACIF and Peridot-TD Spacer are substantially equivalent to predicate devices.