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, 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).

Device Description

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.

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.

AI/ML Overview

This 510(k) submission describes a spinal fixation system, not an AI/ML device. Therefore, the details requested about acceptance criteria and study design for AI/ML devices (e.g., ground truth, reader study, effect size) are not applicable and are not present in the provided text.

The document focuses on demonstrating substantial equivalence to predicate spinal fixation systems based on material, design, dimensions, and sterilization methods.

Here's a summary of the relevant performance data and criteria from the provided text, adapted to reflect what is actually presented:

1. A table of acceptance criteria and the reported device performance

The submission does not specify numerical "acceptance criteria" for performance in the way an AI/ML device would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to legally marketed predicate devices. The reported device performance is presented as being "similar" or "identical" to the predicates across key technical characteristics.

Acceptance Criteria Category	Reported Device Performance (vs. Predicate Devices)
Instruction for Use	Identical
Material	Similar (same materials used: Ti-6Al-4V ELI titanium alloy (ASTM F136) and Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537))
Design with Components	Similar (Screws, Set Screws, Rods, Crosslinks, Connectors, Hooks). The subject device's rods include a Z-rod, which some predicates did not, but another predicate (Olympic Posterior Spinal Fixation System(K181139)) also includes a Z-rod.
Dimensions	Similar range of diameters and lengths for screws and rods. The subject device's Z-rod dimensions (OD Ø 5.5/6.0mm, Length 320mm) are similar to one additional predicate (Olympic Posterior Spinal Fixation System(K181139)).
Sterilization Method	Similar (Sterile device: Gamma radiation; Non-sterile device: recommended steam sterilization (autoclave sterilization)). One additional predicate (Olympic Posterior Spinal Fixation System(K181139)) is non-sterile.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The submission relies on mechanical testing data from existing predicate devices and a comparison of technical characteristics, not a clinical test set from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Since this is a spinal fixation system, the "ground truth" is typically established through engineering and biocompatibility testing, and comparison to existing devices, rather than expert interpretation of medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This is a medical device, not an AI/ML algorithm requiring a reader study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device is demonstrated through robust engineering analysis, material characterization, and mechanical testing to ensure safety and performance, and crucially, by demonstrating substantial equivalence to predicate devices that have already met these standards. The submission 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, K223560 / AccelFix Spinal Fixation System: K182544, K200794, K223565)."

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

Summary

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February 28, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

L&K BIOMED Co., Ltd. Ms. Katherine Kim RA 101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu Yongin-si, Gyeonggi-do 17015 South Korea

Re: K230245

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: January 28, 2023 Received: January 30, 2023

Dear Ms. 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,

Image /page/1/Picture/5 description: The image contains the text "Colin O'neill -S". The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. In the background, there is a faded logo of the letters FDA.

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) K230245

Device Name

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System

Indications for Use (Describe)

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 Druq 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K230245

Device Name AccelFix Spinal Fixation System

Indications for Use (Describe)

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.

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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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 Kim
	khkim@lnkbiomed.com / ra@lnkbiomed.com
Prepared Date	January 27, 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 orthosis
	Spinal intervertebral body fixation orthosis
	Thoracolumbosacral pedicle screw system
	Regulation class / Number
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 and 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 (K120270) 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) Olympic Posterior Spinal Fixation System(K181139)

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MATERIALS 4.

LnK Spinal Fixation System/ OpenLoc-LSpinal Fixation System	Ti-6Al-4V ELI titanium alloy (ASTM F136) andCobalt-28Chromium-6Molybdenum-4VanadiumELI (ASTM F1537)
AccelFix Spinal Fixation System

The additional Z-Rod is manufactured from Ti-6AI-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.

5. DESCRIPTION OF THE DEVICE

LNK SPINAL FIXATION SYSTEM /OPENLOC-L SPINAL FIXATION SYSTEM

ACCELFIX SPINAL FIXATION SYSTEM

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, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

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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,K223560 / AccelFix Spinal Fixation System: K182544, K200794,K223565).

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(K120270)	PrimaryPredicate
LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270, K143363,K171813, K183168, K 200790, K223565)	AdditionalPredicate	Instruction for use including indication aresimilar.
Olympic Posterior Spinal FixationSystem(K181139)

Materials	Devices	Similarities

LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System	Subject	Similar materialsTi-6Al-4V ELI titanium alloy (ASTM F136) Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537)
LnK Spinal Fixation ystem(K120270)	PrimaryPredicate
LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270,K143363, K171813, K183168, K200790, K223565)	AdditionalPredicate
Olympic Posterior Spinal FixationSystem(K181139)

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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(K120270)	PrimaryPredicate	Screws, Set Screws,Rods, Crosslinks,Connectors, Hooks	Rods do not includeZ-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 includeZ-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 ØLength	4.0~~10.5 mm20~~150mm
		Rods	OD ØLength	5.0/5.5/6.0/6.35 mm40~600 mm
		Z-Rod	OD ØLength	5.5/6.0mm320mm
LnK Spinal Fixation System(K120270)	PrimaryPredicate	Screws	OD ØLength	4.0~~10.5 mm20~~150mm
		Rods	OD ØLength	5.0/5.5/6.0/6.35 mm40~600 mm
LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270, K143363,K171813, K183168, K 200790, K223565)	AdditionalPredicate	Screws	OD ØLength	4.0~~10.5 mm20~~150mm
		Rods	OD ØLength	5.0/5.5/6.0/6.35 mm40~600 mm
Olympic Posterior Spinal FixationSystem(K181139)	AdditionalPredicate	Screws	OD ØLength	4.0~~10 mm20~~120mm
		Rods	OD ØLength	5.0/5.5/6.0/6.35 mm-
		Z-Rod	OD ØLength	5.5/6.0mm-

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Sterilization Method	Devices	Similarities
LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System	Subject	Sterile device: Gamma radiation Non-sterile device: recommended steamsterilization (autoclave sterilization)
LnK Spinal Fixation System(K120270)	PrimaryPredicate	Sterile device: Gamma radiation Non-sterile device: recommended steamsterilization (autoclave sterilization)
LnK Spinal Fixation System/OpenLoc-LSpinal Fixation System (K120270, K143363,K171813, K183168, K 200790, K223565)	AdditionalPredicate	Sterile device: Gamma radiation Non-sterile device: recommended steamsterilization (autoclave sterilization)
Olympic Posterior Spinal FixationSystem(K181139)	AdditionalPredicate	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)	AdditionalPredicate	Instruction for use including indication aresimilar.
Olympic Posterior Spinal FixationSystem(K181139)

Materials	Devices	Similarities
	AccelFix Spinal Fixation System	Similar materials
	AccelFix Spinal Fixation System (K182544)	Ti-6Al-4V ELI titanium alloy (ASTM F136)
	AccelFix Spinal Fixation System (K200794, K223565)	Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537)
	Olympic Posterior Spinal Fixation System(K181139)
	Subject
	Primary Predicate
	Additional Predicate

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 Z-rod
AccelFix Spinal Fixation System(K200794, K223565)	AdditionalPredicate	Screws, Set Screws, Rods,Crosslinks, Connectors, Hooks	Rods do notinclude Z-rod
Olympic Posterior Spinal FixationSystem(K181139)	AdditionalPredicate	Screws, Set Screws, Rods,Crosslinks, Connectors, HooksRods include Z-rod

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Dimension	Similarities
Devices
AccelFix Spinal Fixation System	Subject	ScrewsRodsZ-Rod	OD Ø $4.0~~10.5$ mmLength $20~~150$ mmOD Ø $5.5/6.0/6.35$ mmLength $40~600$ mmOD Ø $5.5/6.0$ mmLength $320$ mm
AccelFix Spinal Fixation System (K182544)	Primary Predicate	ScrewsRods	OD Ø $4.0~~10.5$ mmLength $20~~150$ mmOD Ø $5.5/6.0/6.35$ mmLength $40~600$ mm
AccelFix Spinal Fixation System (K200794, K223565)	Additional Predicate	ScrewsRods	OD Ø $4.0~~10.5$ mmLength $20~~150$ mmOD Ø $5.5/6.0/6.35$ mmLength $40~600$ mm
Olympic Posterior Spinal Fixation System(K181139)	Additional Predicate	ScrewsRodsZ-Rod	OD Ø $4.0~~10$ mmLength $20~~120$ mmOD Ø $5.5/6.0/6.35$ mmLength -OD Ø $5.5/6.0$ mmLength -

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)	Primary Predicate	Sterile device: Gamma radiation Non-sterile device: recommended steam sterilization (autoclave sterilization)
AccelFix Spinal Fixation System(K200794, K223565)	Additional Predicate	Sterile device: Gamma radiation Non-sterile device: recommended steam sterilization (autoclave sterilization)
Olympic Posterior Spinal FixationSystem(K181139)	Additional Predicate	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).

Regulation Number and Section

§ 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.