The VEGA Cervical Screw System

K254260 · GS Medical Co., Ltd. · NKG · Sep 17, 2026 · Orthopedic

Device Facts

• Record ID: K254260
• Device Name: The VEGA Cervical Screw System
• Applicant: GS Medical Co., Ltd.
• Product Code: NKG · Orthopedic
• Decision Date: Sep 17, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The VEGA Cervical Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the treatment of the following acute and chronic instabilities of the cervical spine (C1–C7) and the upper thoracic spine (T1–T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VEGA Cervical Screw System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the VEGA Cervical Screw System may be connected to the AnyPlus II Spinal Fixation System, using compatible connectors or transition rods. Please refer to the individual system's Instructions for Use for a complete list of indications for each system.

Device Story

VEGA Cervical Screw System; posterior spinal fixation construct. Components: screws (poly, cortical, shaft, cannulated), rods, crosslinks, connectors. Input: surgical placement into cervical/thoracic spine segments. Operation: creates rigid construct for immobilization/stabilization; adjunct to fusion or palliative stabilization for tumors. Used in OR by surgeons. Output: mechanical stabilization of spinal segments. Benefits: restores spinal integrity; manages instability/deformity; provides palliative support for advanced tumors. Compatible with AnyPlus II Spinal Fixation System via transition rods/connectors.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F1717 (static compression bending, static torsion, dynamic compression bending) and ASTM F1798 (static axial/torsional grip, static/dynamic transverse moment). Results met all acceptance criteria.

Technological Characteristics

Implants: titanium alloy (ASTM F136). Instruments: precipitation hardened stainless steels (STS440A, STS630) per ASTM F899. System includes various screw types (poly, cortical, shaft, cannulated), rods, crosslinks, and connectors. Non-sterile, single-use implants; reusable instruments. Mechanical fixation principle.

Indications for Use

Indicated for patients with acute/chronic cervical (C1-C7) and upper thoracic (T1-T3) spine instabilities, including traumatic fractures/dislocations, deformity, failed fusions, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in advanced tumor patients with limited life expectancy where fusion is not achievable.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• Sovereign Posterior Cervical System (K250866)

Reference Devices

• AnyPlus II Spinal Fixation System

Submission Summary (Full Text)

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**U.S. FOOD & DRUG**
ADMINISTRATION

September 17, 2026

GS Medical Co., Ltd.
% Barry Sands
President and Founder
RQMIS, Inc.
110 Haverhill Road, Suite 524
Amesbury, Massachusetts 01913

Re: K254260

Trade/Device Name: The VEGA Cervical Screw System
Regulation Number: 21 CFR 888.3075
Regulation Name: Posterior Cervical Screw System
Regulatory Class: Class II
Product Code: NKG
Dated: August 19, 2026
Received: August 19, 2026

Dear Barry Sands:

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.

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K254260 - Barry Sands

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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K254260 - Barry Sands

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Sincerely,

COLIN O'NEILL -S

Colin O'Neill, M.B.E.

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

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254260 | ? |
| Please provide the device trade name(s). | | ? |
| The VEGA Cervical Screw System | | |
| Please provide your Indications for Use below. | | ? |
| The VEGA Cervical Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the treatment of the following acute and chronic instabilities of the cervical spine (C1–C7) and the upper thoracic spine (T1–T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VEGA Cervical Screw System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the VEGA Cervical Screw System may be connected to the AnyPlus II Spinal Fixation System, using compatible connectors or transition rods. Please refer to the individual system's Instructions for Use for a complete list of indications for each system. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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K254260 - Page 1 of 3

# **510(k) summary: GS Medical's VEGA Cervical Screw System**

**Date Prepared:** September 15, 2026

# **Submitter's Address, Telephone Number, Contact Person**

Sun Ju Choi
Regulatory Affairs Specialist
GS Medical Co. Ltd.
90 Osongsaengmyong 4-ro
Osong-eup, Heungdeok-gu, Gheongju-si,
Chungcheongbuk-do 28161 KoreaTel.: [phone]
Email: [e-mail]

# **Author:**

Arunkumar Prabhakaran
US RA Submission Manager
Phone: [phone]
Email: [e-mail]

# **Primary Contact:**

Barry E. Sands
RQMIS Inc.
110 Haverhill Road, Suite 524
Amesbury, MA 01913
Phone: [phone]
Email: [e-mail]

# **1.0 SUBJECT DEVICE**

| Trade/Proprietary Name of Device: | The VEGA Cervical Screw System |
| --- | --- |
| Common Or Usual Name: | Posterior Cervical Screw System |
| Classification Name: | Posterior Cervical Screw System |
| Regulation Number: | 21 CFR 888.3075 |
| Classification: | Class 2 |
| Product Code: | NKG |

# **2.0 PREDICATE DEVICES**

# **Primary Predicate:**

| Trade/Proprietary Name of Device: | Sovereign Posterior Cervical System |
| --- | --- |
| 510(k) number | K250866 |
| Common Or Usual Name: | Posterior Cervical Screw System |
| Classification Name: | Posterior Cervical Screw System |
| Regulation Number: | 21 CFR 888.3075 |
| Classification: | Class 2 |
| Product Code: | NKG |

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510(k) summary: GS Medical's VEGA Cervical Screw System

K254260 - Page 2 of 3

### 3.0 INDICATIONS FOR USE

The VEGA Cervical Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the treatment of the following acute and chronic instabilities of the cervical spine (C1–C7) and the upper thoracic spine (T1–T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The VEGA Cervical Screw System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the VEGA Cervical Screw System may be connected to the AnyPlus II Spinal Fixation System, using compatible connectors or transition rods. Please refer to the individual system's Instructions for Use for a complete list of indications for each system.

### 4.0 DEVICE DESCRIPTION

The VEGA Cervical Screw System consists of various screws (Cervical Poly Screw, Cervical Cortical Screw, Cervical Shaft Screw, Cervical Cannulated Screw, Cervical Cortical Cannulated Screw), rods, crosslinks and connectors which are intended to create a rigid spinal construct. All implants are manufactured from titanium alloy per ASTM F136.

The Cervical Screws are available in multiple options, each offered in both cannulated (Poly, Cortical) and non-cannulated (Poly, Cortical, Shaft) versions. The Cervical Poly Screws are available in various diameters and lengths, with consistent incremental sizing (measurements exclude the screw head). The Cervical Cortical Screws are offered in multiple diameters and lengths, also with uniform incremental sizing (excluding the screw head). The Cervical Shaft Screw, Dual, is provided exclusively as a non-cannulated version, available in a standard diameter and a range of lengths with regular increments. The Cervical Preferred Angle Screw shares the same specifications as the Cervical Poly Screw and Cervical Shaft Screw but features a larger screw thread angle than the other two.

With respect to accessories, there are three types of cross-links: Head-to-Head, Rod-to-Rod, and Dura (two configurations: Dura Crosslink and Dura Crosslink Straight). Additionally, connectors are available in four types: Axial (straight and tapered), Parallel (tapered), Lateral (straight and angled) and Offset.

These implants are supplied non-sterile and are not reusable. The instruments in this system are supplied non-sterile and are reusable. Patient contacting portions of the instruments are fabricated from Precipitation Hardened Stainless Steels (STS440A and STS630) that comply with ASTM F899.

### 5.0 PERFORMANCE DATA

The worst-case construct of the VEGA Cervical Screw System underwent testing according to ASTM F1717 (specifically: static compression bending, static torsion, and dynamic compression bending) and ASTM F1798 (specifically: static axial and torsional grip, and static and dynamic transverse moment testing). The results met all acceptance criteria, and demonstrate substantially equivalent mechanical performance to legally marketed predicates.

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# 510(k) summary: GS Medical's VEGA Cervical Screw System

# 6.0 TECHNOLOGICAL COMPARISON

The VEGA Cervical Screw System has similar indications for use, technological characteristics, surgical approach, materials, range of sizes, design, and principles of operation as the predicates. The technological differences between the subject device and the predicate do not raise new questions of safety and effectiveness. Any differences in technological characteristics of the screws and their accessories have been tested and documented. The subject device and predicate have been determined to be substantially equivalent in terms of indications for use, materials, mechanical performance, sterility, and biocompatibility.

# 7.0 CONCLUSIONS

The VEGA Cervical Screw System is substantially equivalent to legally marketed predicate devices.

CONFIDENTIAL