(22 days)
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, and/or lordosis); 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).
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, 6.0 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 working lengths ranging from 20 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm 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.
The provided text is a 510(k) summary for spinal fixation systems. It discusses the substantial equivalence of new components to previously cleared predicate devices.
Crucially, this document does not describe testing related to software or AI-powered devices, nor does it include information about the performance criteria, study design, or ground truth establishment typically associated with such devices.
The performance data section explicitly states: "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, K223565, K230245 / AccelFix Spinal Fixation System: K182544, K200794, K223565, K230245)."
Therefore, I cannot provide the requested information about acceptance criteria or a study that proves a device meets these criteria in the context of an AI/software device. The document is for a physical medical device (spinal fixation system) and relies on demonstrating substantial equivalence to predicate devices through material and design similarities, rather than performance studies with quantitative metrics, test sets, or expert reviews as would be relevant for AI.
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June 27, 2023
Image /page/0/Picture/1 description: The image contains 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 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.
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 South Korea
Re: K231636
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 Dated: June 2, 2023 Received: June 5, 2023
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.
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
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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 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,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231636
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, and/or lordosis); 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 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231636
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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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."
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Image /page/4/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in a dark blue font. Above the text is the phrase "LEARNING & KNOWLEDGE BIOMED" in a smaller font. To the right of the text is a circular graphic made up of several smaller circles in varying shades of blue.
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-gilGiheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea |
| Submitter's Telephone: | +82-2-6717-1983 |
| Contact Person: | Katherine Kimkhkim@lnkbiomed.com / ra@lnkbiomed.com |
| Prepared Date | June 2, 2023 |
DEVICE IDENTIFICATION 2.
| Trade or Proprietary Name | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System |
|---|---|
| Common or Usual Name | Spinal interlaminal fixation orthosisSpinal intervertebral body fixation orthosisThoracolumbosacral 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 orthosisSpinal intervertebral body fixation orthosisThoracolumbosacral 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 Device: LnK Spinal Fixation System (K230245) Additional Predicate Devices: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System (K120270, K143363, K171813, K183168, K 200790, K223565) Olympic Posterior Spinal Fixation System(K181139)
AccelFix Spinal Fixation System
Primary Predicate Device: AccelFix Spinal Fixation System (K182544) Additional Predicate Devices: AccelFix Spinal Fixation System (K200794, K223565, K230245) Olympic Posterior Spinal Fixation System(K181139)
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Image /page/5/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in a sans-serif font, with the words "LEARNING & KNOWLEDGE BIOMED" in a smaller font above the main text. To the right of the text is a circular graphic made up of several smaller circles in varying shades of blue.
4. MATERIALS
| MATERIALS | |
|---|---|
| LnK Spinal Fixation System/ OpenLoc-LSpinal Fixation System | Ti-6Al-4V ELI titanium alloy (ASTM F136) andCobalt-28Chromium-6Molybdenum-4Vanadium |
| AccelFix Spinal Fixation System | ELI (ASTM F1537) |
The additional S-Rod is manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) and Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). This this is the same material used in the predicate devices.
న. DESCRIPTION OF THE DEVICE
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, 6.0 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 working lengths ranging from 20 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm 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.
INDICATION FOR USE 6.
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, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).
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Image /page/6/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in a dark blue, sans-serif font. Above the text is the phrase "LEARNING & KNOWLEDGE BIOMED" in a smaller font size. To the right of the text is a circular graphic made up of several smaller circles in varying shades of blue.
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, K223565, K230245 / AccelFix Spinal Fixation System: K182544, K200794, K223565, K230245).
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
- Material .
- · · Design with components
- . Dimension
- Sterilization Method .
The following technological similarities and differences exist between the subject and predicate devices:
LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM
| INDICATION FOR USE | Devices | Similarities | |
|---|---|---|---|
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System | Subject | ||
| LnK Spinal Fixation System(K230245) | PrimaryPredicate | ||
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270, K143363,K171813, K183168, K 200790, K223565) | AdditionalPredicate | Instruction for use including indication issimilar. | |
| Olympic Posterior Spinal FixationSystem(K181139) |
| Materials | Devices | Similarities |
|---|---|---|
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System | Subject | |
| LnK Spinal Fixation System(K230245) | Primary Predicate | Similar materials |
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270,K143363, K171813, K183168, K 200790,K223565) | Additional Predicate | Ti-6Al-4V ELI titanium alloy (ASTM F136) Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537) |
| Olympic Posterior Spinal FixationSystem(K181139) |
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Image /page/7/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in a sans-serif font, with the words "LEARNING & KNOWLEDGE BIOMED" in a smaller font above the main text. To the right of the text is a circular graphic made up of several smaller blue circles of varying sizes.
| Design with Components | Similarities | Dissimilarities | |
|---|---|---|---|
| Devices | |||
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System | Subject | Screws, Set Screws,Rods, Crosslinks,Connectors, HooksRods include Z-rod | |
| LnK Spinal Fixation System(K230245) | PrimaryPredicate | Screws, Set Screws,Rods, Crosslinks,Connectors, Hooks | Rods do not includeS-rod |
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270, K143363,K171813, K183168, K 200790, K223565) | AdditionalPredicate | Screws, Set Screws,Rods, Crosslinks,Connectors, Hooks | Rods do not includeS-rod |
| Olympic Posterior Spinal FixationSystem(K181139) | AdditionalPredicate | Screws, Set Screws,Rods, Crosslinks,Connectors, HooksRods include Z-rod |
| Dimension | Devices | Similarities | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System | Subject | Screws OD Ø 4.0 | ||||||||||||||||||||||||
| LnK Spinal Fixation System(K230245) | PrimaryPredicate | Screws OD Ø 4.0 | ||||||||||||||||||||||||
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270, K143363,K171813, K183168, K 200790, K223565) | AdditionalPredicate | Screws OD Ø 4.0 | ||||||||||||||||||||||||
| Olympic Posterior Spinal FixationSystem(K181139) | AdditionalPredicate | Screws OD Ø 4.0 |
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Image /page/8/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in a dark blue font. Above the text is the phrase "LEARNING & KNOWLEDGE BIOMED" in a smaller font. To the right of the text is a circular graphic made up of several blue circles of varying sizes.
| Sterilization Method | ||
|---|---|---|
| Devices | Similarities | |
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System | Subject | Sterile device: Gamma radiation Non-sterile device: recommended steam sterilization (autoclave sterilization) |
| LnK Spinal Fixation System(K230245) | Primary Predicate | Sterile device: Gamma radiation Non-sterile device: recommended steam sterilization (autoclave sterilization) |
| LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270, K143363,K171813, K183168, K 200790, K223565) | Additional Predicate | Sterile device: Gamma radiation Non-sterile device: recommended steam sterilization (autoclave sterilization) |
| Olympic Posterior Spinal FixationSystem(K181139) | Additional Predicate | Non-sterile |
ACCELFIX SPINAL FIXATION SYSTEM
| INDICATION FOR USE | ||
|---|---|---|
| Devices | Similarities | |
| AccelFix Spinal Fixation System | Subject | |
| AccelFix Spinal Fixation System (K182544) | PrimaryPredicate | |
| AccelFix Spinal Fixation System (K200794,K223565, K230245) | AdditionalPredicate | Instruction for use including indication aresimilar. |
| Olympic Posterior Spinal FixationSystem(K181139) | Predicate |
| Materials | ||
|---|---|---|
| Devices | Similarities | |
| AccelFix Spinal Fixation System | Subject | |
| AccelFix Spinal Fixation System (K182544) | Primary Predicate | Similar materials |
| Ti-6Al-4V ELI titanium alloy (ASTM F136) | ||
| AccelFix Spinal Fixation System (K200794, K223565, K230245) | Additional Predicate | Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537) |
| Olympic Posterior Spinal Fixation System(K181139) |
| Design with Components | |||
|---|---|---|---|
| Devices | Similarities | Dissimilarities | |
| AccelFix Spinal Fixation System | Subject | Screws, Set Screws, Rods,Crosslinks, Connectors, HooksRods include Z-rod | |
| AccelFix Spinal Fixation System (K182544) | PrimaryPredicate | Screws, Set Screws, Rods,Crosslinks, Connectors, Hooks | Rods do notinclude S-rod |
| AccelFix Spinal Fixation System (K200794,K223565, K230245) | AdditionalPredicate | Screws, Set Screws, Rods,Crosslinks, Connectors, Hooks | Rods do notinclude S-rod |
| Olympic Posterior Spinal FixationSystem(K181139) | AdditionalPredicate | Screws, Set Screws, Rods,Crosslinks, Connectors, HooksRods include Z-rod |
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Image /page/9/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in a dark blue font. Above the text is the phrase "LEARNING & KNOWLEDGE BIOMED" in a smaller font. To the right of the text is a circular graphic made up of several blue circles of varying sizes and shades.
| Dimension | Devices | Similarities | ||
|---|---|---|---|---|
| AccelFix Spinal Fixation System | Subject | ScrewsRodsZ-RodS-Rod | OD Ø 4.0 | |
| AccelFix Spinal Fixation System (K182544) | PrimaryPredicate | ScrewsRods | OD Ø 4.0 | |
| AccelFix Spinal Fixation System (K200794, K223565, K230245) | AdditionalPredicate | ScrewsRodsS-Rod | OD Ø 4.0 | |
| Olympic Posterior Spinal Fixation System(K181139) | AdditionalPredicate | ScrewsRodsZ-Rod | OD Ø 4.0 |
| Sterilization Method | ||
|---|---|---|
| Devices | Similarities | |
| AccelFix Spinal Fixation System | Subject | Sterile device: Gamma radiation Non-sterile device: recommended steam sterilization (autoclave sterilization) |
| AccelFix Spinal Fixation System (K182544) | PrimaryPredicate | Sterile device: Gamma radiation Non-sterile device: recommended steam sterilization (autoclave sterilization) |
| AccelFix Spinal Fixation System (K200794,K223565, K230245) | AdditionalPredicate | Sterile device: Gamma radiation Non-sterile device: recommended steam sterilization (autoclave sterilization) |
| Olympic Posterior Spinal FixationSystem(K181139) | AdditionalPredicate | Non-sterile |
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 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, K223565, K230245).
§ 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.