(32 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
No
The device is a spinal fixation system, intended as an adjunct to fusion for immobilization of spinal segments, which falls under the category of medical implants used for structural support rather than direct therapeutic treatment.
No
This device is described as a "Spinal Fixation System" intended to provide "immobilization of spinal segments as an adjunct to fusion." Its components are physical implants (screws, rods) designed to mechanically support the spine. There is no mention of it performing any diagnostic function like analyzing data, providing interpretations, or aiding in medical condition identification.
No
The device description explicitly states it is a "multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy". This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to provide immobilization and stabilization of the spine as an adjunct to fusion. This is a therapeutic and structural function within the body.
- Device Description: The device description details a system of physical components (screws, rods, etc.) made of metal alloys, designed to be surgically implanted.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described are mechanical tests evaluating the physical strength and durability of the implant components, not diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples to provide diagnostic information. This device is an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
The LOSPA IS Spinal Fixation Systems are 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system, The LOSPA Spinal Fixation Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
Product codes
NKB, KWQ
Device Description
The LOSPA IS Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The LOSPA® ISTM Spinal Fixation System consists of an assortment of pedicle screws, set screws, lateral offsets, bone screws and screw bodies. The LOSPA® ISTM Spinal Fixation System implants are not compatible with components or metal from any other manufacturer's system.
The LOSPA IS Spinal Fixation System is this submission comprises of the following components,
A. Pedicle Screws (Mono-axial & Poly-axial), standard, guided, cannulated, cannulated MIS types, with screw diameters from 4.0 mm to 8.5mm (to 9.5 mm only Poly-axial) and length range from 20 mm to 140 mm, made up of Titanium Alloy (ASTM F 136).
B. Straight Rods of diameter of 5.5 mm and 6.0 mm (Standard) made up of Titanium Alloy (ASTM F 136).
C. Prebent Rods of diameter 5.5mm (Standard & Bullet types) and 6.0 mm(Standard, Bullet, MIS) made up of Titanium Alloy (ASTM F 136) & CoCr (ASTM F 1537)
D. Rod link made up of Titanium Alloy (ASTM F 136).
All the components are manufactured from medical grade titanium alloy (ASTM F 136) & CoCrMo alloy (ASTM F 1537).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Performance testing -mechanical testing was carried out to demonstrate substantial equivalence and the subject device performed either similar or better than comparable predicate devices.
The LOSPA IS Spinal Fixation System components were subjected to a series testing requirements to demonstrate substantial equivalence and included methods described in the following standards: ASTM F1717 (static and dynamic compression bending, static torsion); ASTM F543 (axial screw pull-out). Mechanical testing of the subject device consisted of Rods & Pedicle screws compression bending test, Rods & Cannulated pedicle screws compression, Rod & Pedicle screws torsional test, dynamic fatigue test, pedicle screw axial pull-out test.
Key Metrics
Not Found
Predicate Device(s)
K132644, K092076, K071373(T), K083393(T), K091291(S), K143363, K160124, K110283, K142185, K183117, K161766
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.
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.
March 6, 2020
Corentec Co., Ltd. Sungwon Yang Director- QA&RA 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, 31056 Kr
Re: K200267
Trade/Device Name: LOSPA® ISTM Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ Dated: December 6, 2019 Received: February 3, 2020
Dear Sungwon Yang:
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 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
1
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 (QS) 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 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,
for
Ronald P. Jean, Ph.D. Director (Acting) 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)
Device Name
LOSPA® IS™ Spinal Fixation System
Indications for Use (Describe)
The LOSPA IS Spinal Fixation Systems are 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system, The LOSPA Spinal Fixation Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
Corentec Co., Ltd. LOSPA® IS™ Spinal Fixation System
LOSPA® IS™ Thoracolumbar Pedicle Screw Rhino™ Percutaneous Pedicle Screw 6th Dec.,2019
ADMINISTRATIVE INFORMATION
| Manufacturer: | Corentec Co., Ltd.
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu
Cheonan-si, Chungchongnam-do, Rep. of Korea -31056
Telephone: +82-41-585-7114; Fax: +82-41-585-7113 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Sungwon Yang
Director - QA&RA
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu
Cheonan-si, Chungchongnam-do, Rep. of Korea -31056
Ph: +82-41-410-7176 (Direct) ; Fax: +82-41-585-7113
Email: sungwon.yang@corentec.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | LOSPA® IST™ Spinal Fixation System |
|---|---|
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Classification Regulations: | 21 CFR 888.3070 |
| Regulatory Class: | Class II |
| Product Codes: | NKB, KWQ |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
INDICATIONS FOR USE
The LOSPA IS Spinal Fixation Systems are 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). When used as an anterior screw fixation system, The LOSPA IS Spinal Fixation Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
4
DEVICE DESCRIPTION
The LOSPA IS Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The LOSPA® ISTM Spinal Fixation System consists of an assortment of pedicle screws, set screws, lateral offsets, bone screws and screw bodies. The LOSPA® ISTM Spinal Fixation System implants are not compatible with components or metal from any other manufacturer's system.
The LOSPA IS Spinal Fixation System is this submission comprises of the following components,
A. Pedicle Screws (Mono-axial & Poly-axial), standard, guided, cannulated, cannulated MIS types, with screw diameters from 4.0 mm to 8.5mm (to 9.5 mm only Poly-axial) and length range from 20 mm to 140 mm, made up of Titanium Alloy (ASTM F 136).
B. Straight Rods of diameter of 5.5 mm and 6.0 mm (Standard) made up of Titanium Alloy (ASTM F 136).
C. Prebent Rods of diameter 5.5mm (Standard & Bullet types) and 6.0 mm(Standard, Bullet, MIS) made up of Titanium Alloy (ASTM F 136) & CoCr (ASTM F 1537)
D. Rod link made up of Titanium Alloy (ASTM F 136).
All the components are manufactured from medical grade titanium alloy (ASTM F 136) & CoCrMo alloy (ASTM F 1537).
SUBSTANTIAL EQUIVALENCE
LOSPA IS Spinal Fixation System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
| Device
Type | Manufacturer | Trade or Proprietary
or Model Name | 510(k) | Referenc
e for |
|----------------------|--------------------|---------------------------------------------------------------------------|-------------|-----------------------|
| Primary
Predicate | Corentec Co., Ltd. | LOSPA IS Spinal System | K132644 | All
componen
ts |
| | Corentec Co., Ltd. | AEGIS & AEGIS II Spinal Systems
(Renamed as LOSPA IS Spinal
System) | K092076 | |
| Additional | Stryker | Xia 3 Spinal System | K071373(T). | Pedicle |
Substantially equivalent products for LOSPA IS Spinal Fixation System are as follows,
5
| Predicate | | | K083393(T),
K091291(S) | Screws |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------|---------------------------|--------|
| L&K BIOMED | LnK Spinal Fixation system | K143363 | | |
| SpineVision, S.A. | SpineVision LUMIS™ Cannulated
Pedicle Screw Fixation System,
SpineVision U.L.I.S.™ Pedicle
Screw Fixation System | K160124 | Cannulate
d
Screws | |
| MEDYSSEY CO.,
LTD. | ZENIUS SPINAL SYSTEM | K110283 | | |
| DePuy Synthes | EXPEDIUM VERSE SPINE
SYSTEM | K142185 | MIS | |
| L&K Biomed Co.,
Ltd. | PathLoc-L MIS Spinal System | K183117
(K161766) | screws | |
The LOSPA IS Spinal Fixation System is similar to the cleared devices as mentioned above with respect to indications, design, operating principles and material. This system consists of various Pedicle screws (Mono-axial/ Poly-axial) with a variety of type designs such as standard, guided, cannulated (Poly-axial only), cannulated MIS (Short, Long) type. Rods (Straight, Standard, Bullet type) and Rod Link (A/B/C type) with a set screw, the assembly of which is intended to provide temporary stabilization following surgery to fuse the spine. The components of Pedicle screw (Mono-axial/ Poly-axial) and Set screw, Rod Link are available in titanium alloy (ASTM F136) specifications as non sterile. The rod components are available in titanium alloy (ASTM F136) or cobalt-chrome alloy (ASTM F1537) specifications as non sterile and are either straight or pre-bent in configuration.
Furthermore, the materials are included in this submission for all of components of the LOSPA IS Spinal system same as material cleared in Corentec's own reference devices.
The LOSPA IS Spinal Fixation System and the predicate devices components are similar in overall shape and design & materials used. The subject device and the predicate devices encompass a similar range of physical dimensions, including the diameter and length of pedicle screws II, Cannulated screws, MIS screws, and rods.
Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.
PERFORMANCE DATA
Special 510(k): Specification Inclusion
Performance testing -mechanical testing was carried out to demonstrate substantial equivalence and the subject device performed either similar or better than comparable predicate devices.
The LOSPA IS Spinal Fixation System components were subjected to a series testing requirements to demonstrate substantial equivalence and included methods described in the following standards: ASTM F1717 (static and dynamic compression bending, static torsion); ASTM F543 (axial screw pull-out). Mechanical testing of the subject device
6
consisted of Rods & Pedicle screws compression bending test, Rods & Cannulated pedicle screws compression, Rod & Pedicle screws torsional test, dynamic fatigue test, pedicle screw axial pull-out test.
Overall, the LOSPA IS Spinal Fixation System has the following similarities to the predicate devices:
- · has the same intended use,
- · uses the same operating principles,
- · incorporates the same basic designs.
- · incorporates the same materials, and
- · has same packaging materials and processes.
STERILIZATION & PACKAGING
The LOSPA IS Spinal Fixation System is supplied non-sterile and cited predicate devices are non-sterile.
CONCLUSION
Corentec Co., Ltd. believes that the subject device is substantially equivalent to the legally marketed predicate device based on intended use, technology, materials, as well as the mechanical testing and biocompatibility assessment.