(152 days)
Not Found
No
The device description and intended use focus solely on mechanical components for spinal fixation and fusion. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is indicated for the treatment of severe Spondylolisthesis and other spinal instabilities or deformities, which is a therapeutic purpose.
No
Explanation: The device is a pedicle screw system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, set screws, and a cross link linking mechanism, fabricated from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
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 for diagnosis, monitoring, or screening.
- Device Description: The Xing™ Spine System is a surgical implant consisting of pedicle screws, rods, set screws, and a cross link mechanism. It is designed to be surgically implanted into the spine to provide stabilization and promote fusion.
- Intended Use: The intended use is for the surgical treatment of spinal conditions by providing mechanical support and stabilization. It does not involve testing samples from the body.
The description clearly indicates a device that is surgically implanted, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Xing™ Spine System 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 Xing™ Spine System 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, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI
Device Description
The Xing 10 Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a cross link linking mechanism.
The Xing™ Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Xing™ System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the Xing™ Spine System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra, lumbar and sacral spine (L3 to sacrum), thoracic, lumbar and sacral spine
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)
Mechanical testing as listed in APPENDIX 3 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices.
Mechanical test reports were completed for the following test methods:
- Static test: Tension, Compression and Torsion test report (ASTM F1717-09) -
- Dynamic test: Fatigue test report (ASTM F1717-09) -
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.
K001668, K031585, K060702, K041808, K071857
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
§ 888.3070 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.
0
510(k) Summary
Submitter: IMPLANOVA Co., Ltd. Tae Gon Jung #104, Gyongnam Techno-park,155-1 Nongso-ri, Juchon-myeon, Gimhae, Gyeongnam, 621-842, South Korea Phone: 82-55-329-5292 Fax: 82-55-329-5294
Device Information
Trade Name: Xing™ Spine System
Pedicle Screw Spinal Fixation System Common Name:
Classification Name: Pedicle Screw Spinal Fixation System
MNH, MNI Product Code:
Regulation Number: 21 CFR 888.3070
The date prepared: 7/11/2011
General Description
The Xing 10 Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a cross link linking mechanism.
The Xing™ Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Xing™ System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the Xing™ Spine System
Indication for Use
The Xing™ Spine System 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 Xing M Spine System 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, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
FDA/CDRH/DCC DEC 06 2011 RECEIVED
Official Correspondent:
325 N. Puente St. Unit B
Phone: 714-525-0114
Fax: 714-525-0116
Email: kodentinc@gmail.com
Kodent Inc. April Lee
Brea, CA 92821
Image /page/0/Picture/18 description: The image is a blank white canvas, devoid of any discernible objects, shapes, or colors. The uniformity of the white background creates a sense of emptiness and simplicity. There are no textures or patterns visible, resulting in a smooth and featureless surface. The image lacks any focal point or visual interest, presenting a minimalist and abstract composition.
411 995 DEC 1 2 2011
1
Materials:
The devices are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
Performance Data (Bench Testing):
Mechanical testing as listed in APPENDIX 3 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices.
Mechanical test reports were completed for the following test methods:
- Static test: Tension, Compression and Torsion test report (ASTM F1717-09) -
- Dynamic test: Fatigue test report (ASTM F1717-09) -
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
-
- OPTIMA™, Spinal System (U & I Co., Ltd; K001668)
-
- Global Spinal Fixation System (D.K.M. Co., Ltd; K031585)
-
- 4CIS® Vane Spine System (Solco Biomedical Co., Ltd.; K060702)
-
- Title®2 Spinal System(ENDIUS, INC; K041808)
-
- DELTA SPINAL FUSION SYSTEM(JEMO SPINE, LLC; K071857)
Comparison to Predicate Devices:
The subject device, Xing™ Spine System, is substantially equivalent to OPTIMA™, Spinal System manufactured by U & I Co., Ltd which was cleared for marketing as K031585 and the Global Spinal Fixation System manufactured by D.K.M. Co., Ltd which was cleared for marketing as K001668 and the 4CIS Vane Spine System manufactured by Solco Biomedical Co., Ltd which was cleared for marketing as K060702 and the Title®2 Spinal System manufactured by ENDIUS, INC. which was cleared for marketing as K041808 and DELTA SPINAL FUSION SYSTEM manufactured by JEMO SPINE, LLC which was cleared for marketing as K071857.
| | Subject Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device |
|---------|-----------------------|---------------------|---------------------|---------------------------------|---------------------|---------------------|
| Company | Implanova co.,
Ltd | U & I Co., Ltd | D.K.M. Co., Ltd | Solco
Biomedical Co.,
Ltd | ENDIUS, INC. | JEMO SPINE,
LLC |
2
KIII 995
page 3 of 4
| Device
Name | Xing™ Spine
System | OPTIMA™,
Spinal System | Global Spinal
Fixation System | 4 CIS VANE
Spine System | Title®2
spinal system | DELTA
SPINAL
FUSION
SYSTEM |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------|
| 510(k)
Number | N/A | K001668 | K031585 | K060702 | K041808 | K071857 |
| Device
Classificati
on Name | Orthosis,
Spondyloisthesi
s Spinal
Fixation | Orthosis,
Spondyloisthesi
s Spinal
Fixation | Orthosis,
Spondyloisthesi
s Spinal
Fixation | Orthosis,
Spondyloisthesi
s Spinal
Fixation | appliance,
fixation, spinal
interlaminal | orthosis, spinal
pedicle fixation |
| Classificati
on Product
Code | MNH, MNI | MNH, MNI | MNH, MNI | MNH, MNI | MNH, MNI,
NKB | MNI |
| Regulation
Number | 888.3070 | 888.3070 | 888.3070 | 888.3070 | 888.3050 | 888.3070 |
| Intended
Use | See the
indications for
use statement | Identical | Identical | Identical | Identical | Identical |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Product
Parts | Pedicle Screw,
Rod(Straight
type & curved
type), Nut,
Transverse Link | Pedicle Screw,
Rod(Straight
type & curved
type), Set
Screw,
Transverse Link | Pedicle Screw,
Rod(Straight
type & curved
type),
Connector,
Transverse Link | Pedicle Screw,
Rod, Set Screw,
Transverse
Link(Identical) | Pedicle Screw,
Rod, Set Screw,
Connector | Pedicle Screw,
Rod, Set Screw |
| Size of
pedicle
screw | 4.0, 4.5, 5.0,
5.5, 6.0, 6.5,
7.0, 8.0 in
diameter and
from 20 to
55mm in a 5mm
increment | 5.0, 6.0, 7.0,
7.5, 8.0mm
diameter in 30,
35, 40, 45, 50,
55mm length | 5.0, 6.0, 7.0,
7.5, 8.0mm
diameter in 30,
35, 40, 45, 50,
55mm length | 4.0, 4.5, 5.5,
6.5, 7.5, 8.0,
8.5mm diameter
in 25~60mm
length(Similar) | | |
| Pre-
Bending
Rod | Available | | | Available | | |
| The amount
of
angulation
possible | | | | | 60° | 86° |
Any differences between the subject devices and the predicate devices will not affect safety or efficacy. Please see APPENDIX 2 Predicate Device Information that contains:
- K001668, K031585/K06072 Summary of Safety & Effectiveness documents -
- OPTIMA™, Spinal System/Global Spinal Fixation System/4CIS Spine System product literatures
3
Image /page/3/Picture/0 description: The image contains a handwritten string of characters. The string appears to be "KIII 995". The characters are written in a simple, somewhat messy style, with varying stroke thicknesses. The image is in black and white.
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
page 4 of 4
Based on the comparison between the subject and predicate devices provided in Table 3, IMPLANOVA Co., Ltd believes that the Xing™ Spine System is substantially equivalent to the predicate devices.
Conclusion
Testing and other comparisons have established that the Xing™ Spine System is substantially equivalent in design, materials, indications, and performance to other predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 2 2011
Implanova Co., Ltd. % Kodent, Inc. Ms. April Lee 325 North Puente Street, Unit B Brea, California 92821
Re: K111995
Trade/Device Name: Xing™ Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: November 30, 2011 Received: December 06, 2011
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 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
5
Page 2 - Ms. April Lee
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
| 510(K) Number (if known): | K111995 |
|---|---|
| Device Name: | Xing™ Spine System |
Indication for Use:
The Xing™ Spine System 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 Xing™ Spine System 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,
kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
| Prescription Use x (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter _______ (Per 21 CFR 801 Subpart C) |
|---|---|---|
| -------------------------------------------------- | -------- | ----------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Di
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIII 445 510(k) Number_