(24 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a spinal fixation system, used to treat conditions like degenerative disc disease, trauma, and deformities, acting as an adjunct to fusion. These are all medical conditions, indicating a therapeutic purpose.
No
The device is a spinal fixation system, which is an implantable surgical device used to stabilize the spine, not to diagnose a condition. It is an "adjunct to fusion" for various spinal conditions.
No
The device description explicitly lists physical components such as screws, rods, crosslinks, connectors, and hooks, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a "spinal fixation system" comprised of physical components like screws, rods, crosslinks, connectors, and hooks. These are implanted devices used to stabilize the spine.
- Intended Use: The intended use describes the surgical application of these components for treating various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
The text describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: 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); tumor; stenosis, and failed previous fusion (pseudoarthrosis).
The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (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: 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); tumor; stenosis, and failed previous fusion (pseudoarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWQ
Device Description
LNK SPINAL FIXATION SYSTEM /OPENLOC-L SPINAL FIXATION SYSTEM
The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 5.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.
ACCELFIX SPINAL FIXATION SYSTEM
The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm diameters with lengths ranging from 30 mm to 150 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal (T1-S2/ilium), (T8-L5)
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)
The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System with the predicate device (LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System -K120270, K143363, K171813, K183168, K200790, / AccelFix Spinal Fixation System: K182544, K200794).
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.
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.
K143363, K171813, K183168, K 200790, K200794
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
December 23, 2022
Image /page/0/Picture/1 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized caduceus symbol. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the acronym "FDA" in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text to the right of the square.
L&K Biomed Co., Ltd. Katherine Kim RA 101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu Yongin-si, Gyeonggi-do 17015 Korea. South
Re: K223565
Trade/Device Name: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: November 26, 2022 Received: November 29, 2022
Dear Katherine 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.
1
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 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 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.
Anne D. Talley -S for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223565
Device Name
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System
Indications for Use (Describe)
The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: 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); tumor; stenosis, 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) |
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
"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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223565
Device Name AccelFix Spinal Fixation System
Indications for Use (Describe)
The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (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: 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); tumor; stenosis, and failed previous fusion (pseudoarthrosis).
| 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
"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."
4
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. SUBMITTER
| Submitter's Name: | L&K BIOMED Co., Ltd. |
|---|---|
| Submitter's Address: | #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil |
| Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea | |
| Submitter's Telephone: | +82-2-6717-1983 |
| Contact Person: | Katherine Kim |
| khkim@lnkbiomed.com / ra@lnkbiomed.com | |
| Prepared Date | December 20, 2022 |
2. DEVICE IDENTIFICATION
| Trade or Proprietary Name | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System |
|---|---|
| Common or Usual Name | Spinal interlaminal fixation orthosis |
| Spinal intervertebral body fixation orthosis | |
| Thoracolumbosacral pedicle screw system | |
| Regulation class / Number | Class II, 21 CFR 888.3070 |
| Regulation Name | Thoracolumbosacral pedicle screw system |
| Product Code | NKB, KWP, KWQ |
| Classification Panel | Spinal Devices (DHT6B) |
| Trade or Proprietary Name | AccelFix Spinal Fixation System |
|---|---|
| Common or Usual Name | Spinal interlaminal fixation orthosis |
| Spinal intervertebral body fixation orthosis | |
| Thoracolumbosacral pedicle screw system | |
| Regulation class / Number | Class II, 21 CFR 888.3070 |
| Regulation Name | Thoracolumbosacral pedicle screw system |
| Product Code | NKB, KWP, KWQ |
| Classification Panel | Spinal Devices (DHT6B) |
3. PREDICATE OR LEGALLY MARKETED DEVICES WHICH ARE SUBSTANTIALLY EQUIVALENT.
The additional components of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System 18and AccelFix Spinal Fixation System are considered substantially equivalent to the predicate devices. The systems have same design, materials, scientific technology, and indications for use.
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System
- · Primary predicate: LnK Spinal Fixation System (K120270)
- Additional predicates: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System (K143363, K171813, K183168, K 200790)
AccelFix Spinal Fixation System
- · Primary Predicate: AccelFix Spinal Fixation System (K182544)
- · Additional predicate: AccelFix Spinal Fixation System (K200794)
5
MATERIALS 4.
| LnK Spinal Fixation System/ OpenLoc-L
Spinal Fixation System
AccelFix Spinal Fixation System | Ti-6Al-4V ELI titanium alloy (ASTM F136) and
Cobalt-28Chromium-6Molybdenum-4Vanadium
ELI (ASTM F1537) |
| ---------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------- |
|---|
And the additional domino connector w type is manufactured from Ti-6A1-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices.
DESCRIPTION OF THE DEVICE న్.
LNK SPINAL FIXATION SYSTEM /OPENLOC-L SPINAL FIXATION SYSTEM
The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 5.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.
ACCELFIX SPINAL FIXATION SYSTEM
The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm diameters with lengths ranging from 30 mm to 150 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.
6. INDICATION FOR USE
LNK SPINAL FIXATION SYSTEM /OPENLOC-L SPINAL FIXATION SYSTEM
The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is indicated as an adjunct to fusion for all of the following indications regardless of the intended use: 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, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).
ACCELFIX SPINAL FIXATION SYSTEM
The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (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: 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, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).
6
7. PERFORMANCE DATA
The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System with the predicate device (LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System -K120270, K143363, K171813, K183168, K200790, / AccelFix Spinal Fixation System: K182544, K200794).
SUMMARY OF TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 8.
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Instruction for use i
- Design י
- י Dimension
- י Material
- י Approach
- י Sterilization & Method
The following technological similarities and differences exist between the subject and predicate devices:
| Characteristics | This subject | Predicate device | |
|---|---|---|---|
| Instruction | |||
| for use | Similarities | Instruction for use including indication for use are same | Instruction for use including indication for use are same |
| Design | Similarities | This Domino Connector W Type | |
| (OpenLoc-L) belongs to Rod-to-Rod | |||
| connector type, and this connector is | |||
| used to connect rod to rod. | Predicate domino connector belongs to | ||
| Rod-to-Rod connector type, and this | |||
| connector is used to connect rod to | |||
| rod. | |||
| Differences | This Domino Connector W Type | ||
| (OpenLoc-L), there are two open holes | |||
| in the top, slide the rod from top to | |||
| bottom into these open holes and | |||
| tighten with set screws. | The predicate domino connector has | ||
| two holes on the side where rods can | |||
| be inserted and is connected by | |||
| inserting rods into the two holes. | |||
| The rod diameter that can be used for | |||
| the added Domino connector W type | |||
| (OpenLoc-L) is 5.5mm rod and 6mm | |||
| rod. | The rod diameter that can be used for | ||
| the Predicate domino connector is | |||
| from 5.0mm rod to 6.35mm rod. | |||
| Material | Similarities | The raw materials of LnK Spinal | |
| Fixation System/OpenLoc-L Spinal | |||
| Fixation System are made of Ti-6Al-4V | |||
| ELI titanium alloy (ASTM F136) and | |||
| Cobalt-28Chromium-6Molybdenum- | |||
| 4Vanadium ELI (ASTM F1537). | The raw materials of LnK Spinal | ||
| Fixation System/OpenLoc-L Spinal | |||
| Fixation System are made of Ti-6Al-4V | |||
| ELI titanium alloy (ASTM F136) and | |||
| Cobalt-28Chromium-6Molybdenum- | |||
| 4Vanadium ELI (ASTM F1537). | |||
| This Domino Connector W Type | |||
| (OpenLoc-L) is made of Ti-6Al-4V ELI | |||
| titanium alloy (ASTM F136). | Predicate device (domino connector) is | ||
| made of Ti-6Al-4V ELI titanium alloy | |||
| (ASTM F136). | |||
| Approach | Similarities | Use a similar approach | Use a similar approach |
| Sterilization | |||
| & Method | Similarities | Sterile device: Gamma radiation | |
| • | |||
| Non-sterile device: | |||
| • | |||
| recommended steam sterilization | |||
| (autoclave sterilization) | Sterile device: Gamma radiation | ||
| • | |||
| Non-sterile device: recommended | |||
| • | |||
| steam sterilization (autoclave | |||
| sterilization) | |||
| Manufacturing process | Similarities | Manufacturing process of additional Domino Connector W Type (OpenLoc-L) | |
| and predicate domino connector are same. |
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
7
| Characteristics | This subject | Predicate device | |
|---|---|---|---|
| Instruction | |||
| for use | Similarities | Instruction for use including indication for use are same | Instruction for use including indication for use are same |
| Design | Similarities | This Domino Connector W Type | |
| (AccelFix) belongs to Rod-to-Rod | |||
| connector type, and this connector is | |||
| used to connect rod to rod. | Predicate domino connector belongs | ||
| to Rod-to-Rod connector type, and | |||
| this connector is used to connect rod | |||
| to rod. | |||
| This Domino Connector W Type | |||
| (AccelFix), there are two open holes | |||
| in the top, slide the rod from top to | |||
| bottom into these open holes and | |||
| tighten with set screws. | The predicate domino connector has | ||
| two holes on the side where rods can | |||
| be inserted and is connected by | |||
| inserting rods into the two holes. | |||
| Differences | The rod diameter that can be used for | ||
| the added Domino connector W type | |||
| (AccelFix) is 5.5mm rod and 6mm | |||
| rod. | The rod diameter that can be used for | ||
| the Predicate domino connector is | |||
| from 5.0mm rod to 6.35mm rod. | |||
| Material | Similarities | The raw materials of AccelFix Spinal | |
| Fixation System are made of Ti-6Al-4V | |||
| ELI titanium alloy (ASTM F136) and | |||
| Cobalt-28Chromium-6Molybdenum- | |||
| 4Vanadium ELI (ASTM F1537). | The raw materials of AccelFix Spinal | ||
| Fixation System are made of Ti-6Al-4V | |||
| ELI titanium alloy (ASTM F136) and | |||
| Cobalt-28Chromium-6Molybdenum- | |||
| 4Vanadium ELI (ASTM F1537). | |||
| This Domino Connector W Type | |||
| (AccelFix) is made of Ti-6Al-4V ELI | |||
| titanium alloy (ASTM F136). | Predicate device (domino connector) is | ||
| made of Ti-6Al-4V ELI titanium alloy | |||
| (ASTM F136) | |||
| Approach | Similarities | Use a similar approach | Use a similar approach |
| Sterilization | |||
| & Method | Similarities | Sterile device: Gamma radiation | |
| • | |||
| Non-sterile device: | |||
| • | |||
| recommended steam sterilization | |||
| (autoclave sterilization) | Sterile device: Gamma radiation | ||
| • | |||
| Non-sterile device: recommended | |||
| • | |||
| steam sterilization (autoclave | |||
| sterilization) | |||
| Manufacturing process | Similarities | Manufacturing process of additional Domino Connector W Type (AccelFix) and | |
| predicate domino connector are same. | Manufacturing process of additional Domino Connector W Type (AccelFix) and | ||
| predicate domino connector are same. |
AccelFix Spinal Fixation System
9. SUBSTANTIAL EQUIVALENCE AND CONCLUSION
The subject additional components of LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.
The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate devices. The overall data lead to the conclusion that the additional components of LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System are substantially equivalent to the predicate devices (K120270, K143363, K171813, K183168, K200790, K182544, K200794).