K Number
K190762
Device Name
The JASPER Spinal Fixation System II
Date Cleared
2019-06-19

(86 days)

Product Code
Regulation Number
888.3070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JASPER Spinal Fixation System II is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: The JASPER Spinal Fixation System II is indicated for the following: - Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Trauma (i.e., fracture or dislocation) - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Stenosis - Pseudoarthrosis - Failed previous fusion The JASPER Spinal Fixation System II is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the JASPER Spinal Fixation System II is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Device Description
The JASPER Spinal Fixation System II is a top-loading multiple component, posterior(thraco-lumbar) spinal fixation system which consists of screws, hooks, rods, set screws, cross links, rod connectors and iliac connectors for spinal deformity system. The JASPER Spinal Fixation System II will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. All products are made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) and CoCrMo alloy(Cobalt-28Chromium-6Molybdenum, ASTM F1537) approved for medical use.
More Information

No
The document describes a mechanical spinal fixation system and explicitly states "Mentions AI, DNN, or ML: Not Found".

No
The device is a spinal fixation system intended to stabilize the spine and promote spinal fusion, acting as an adjunct to fusion for various spinal conditions, rather than providing direct therapy.

No
The device is a spinal fixation system, intended to provide immobilization and stabilization as an adjunct to fusion for various spinal conditions, not to diagnose them.

No

The device description explicitly states it consists of physical components like screws, hooks, rods, etc., made of titanium and CoCrMo alloys. This indicates it is a hardware-based medical device, not software-only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • JASPER Spinal Fixation System II Function: The provided text clearly describes the JASPER Spinal Fixation System II as a system of implants (screws, rods, hooks, etc.) designed to be surgically implanted into the spine to provide stability and promote fusion.
  • Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its purpose is structural support and stabilization within the body.

Therefore, based on the provided information, the JASPER Spinal Fixation System II is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The JASPER Spinal Fixation System II is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

The JASPER Spinal Fixation System II is indicated for the following:

  • Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
  • Spondylolisthesis
  • Trauma (i.e., fracture or dislocation)
  • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
  • Tumor
  • Stenosis
  • Pseudoarthrosis
  • Failed previous fusion

The JASPER Spinal Fixation System II is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the JASPER Spinal Fixation System II is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Product codes

NKB

Device Description

The JASPER Spinal Fixation System II is a top-loading multiple component, posterior(thraco-lumbar) spinal fixation system which consists of screws, hooks, rods, set screws, cross links, rod connectors and iliac connectors for spinal deformity system. The JASPER Spinal Fixation System II will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

All products are made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) and CoCrMo alloy(Cobalt-28Chromium-6Molybdenum, ASTM F1537) approved for medical use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

T1-S2/ilium, T8-L5, L5-S1 vertebra, L3 to sacrum, thoracic, lumbar and sacral spine

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

Prescription Use

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)

No new mechanical testing was performed as no non-previously cleared components were added to the JASPER Spinal Fixation System II.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K173645 The JASPER Spinal Fixation System 1), K182059 The PRASE MIS Spinal System 2)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

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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.

June 19, 2019

GBS Commonwealth Co., Ltd. Mr. Jimmy Kim Regulatory Affairs #C-309, 168 Gasan Digital 1-ro Geumcheon-gu, Seoul South Korea

Re: K190762

Trade/Device Name: The JASPER Spinal Fixation System II Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: March 21, 2019 Received: March 25, 2019

Dear Mr. 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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,

Ronald P. Jean, 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)

K190762

Device Name

The JASPER Spinal Fixation System II

Indications for Use (Describe)

The JASPER Spinal Fixation System II is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

The JASPER Spinal Fixation System II is indicated for the following:

  • Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
  • Spondylolisthesis
  • Trauma (i.e., fracture or dislocation)
  • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
  • Tumor
  • Stenosis
  • Pseudoarthrosis
  • Failed previous fusion

The JASPER Spinal Fixation System II is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the JASPER Spinal Fixation System II is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, purple font, stacked on top of the word "COMMONWEALTH" which is also in purple. Behind the letters is a faded gray globe graphic. The logo is simple and professional.

510(k) SUMMARY

The following 510(k) 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: Jimmy.kim@gbscommonwealth.com
Contact Person:Jimmy Kim
Date preparedMarch, 14, 2019
Trade NameThe JASPER Spinal Fixation System II
Classification21 CFR 888.3070 Thoracolumbosacral pedical screw System,
Class II
Product Code : NKB

2. Purpose of 510(k)

The GBS Commonwealth Co. Ltd., here by submits this traditional 510(k): for Initial product Introduction of The JASPER Spinal Fixation System II.

The Purpose of this 510(k) submission is to combine the existing 510(k) clearance system (K173645 and K182059). The JASPER Spinal Fixation System II has the same intended use and fundamental scientific technology as the previously cleared system.

Predicate or legally marketed devices which are substantially equivalent 3.

  • Primary Predicate Device: K173645 The JASPER Spinal Fixation System 1)
  • Additional Predicate : K182059 The PRASE MIS Spinal System 2)

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Image /page/4/Picture/1 description: The image shows the logo for GBS Commonwealth. The logo is in a dark blue color and features the letters "GBS" in a bold, sans-serif font. Below the letters, the word "COMMONWEALTH" is written in a smaller, sans-serif font. The logo is set against a white background and has a globe behind the letters.

Description of the Device 4.

The JASPER Spinal Fixation System II is a top-loading multiple component, posterior(thraco-lumbar) spinal fixation system which consists of screws, hooks, rods, set screws, cross links, rod connectors and iliac connectors for spinal deformity system. The JASPER Spinal Fixation System II will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

All products are made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) and CoCrMo alloy(Cobalt-28Chromium-6Molybdenum, ASTM F1537) approved for medical use.

5. Indication for Use

The JASPER Spinal Fixation System II is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

The JASPER Spinal Fixation System II is indicated for the following:

  • Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
  • Spondylolisthesis
  • Trauma (i.e., fracture or dislocation)
  • · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
  • Tumor
  • Stenosis
  • Pseudoarthrosis
  • Failed previous fusion

The JASPER Spinal Fixation System II is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

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Image /page/5/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, purple font. Below the letters, the word "COMMONWEALTH" is written in a smaller, bold, purple font. The background of the logo is a light gray color.

In addition, the JASPER Spinal Fixation System II is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Comparison of the technological characteristics of the subject and predicate devices 6.

The JASPER Spinal Fixation System II is the same as the legally marketed devices JASPER Spinal Fixation System and PRASE MIS Spinal System. It has the same design, material, scientific technologies and indications for use.

Performance Testing 7.

No new mechanical testing was performed as no non-previously cleared components were added to the JASPER Spinal Fixation System II.

8. SE Determination

The JASPER Spinal Fixation System II has been demonstrated to be same to the predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).