KLS Martin Sternal Plating System (K032413): The KLS Martin Sternal Plating System is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
KLS Martin Hand Plating System (K040598): The KLS Martin Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
KLS Martin Sternal Talon (K051165): The KLS Martin Sternal Talon is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternal reconstructive procedures.
KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile (K070169): To offer KLS Martin Sternal Talon and KLS Martin Sternal Plating in sterile packaging with the following indications for use: K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Recon Talon (K122860): The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternal reconstructive procedures.
LINOS MOH Hand Plating System (K141489): The LINOS MOH Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
KLS Martin LSS Plating System (K151983): The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension.
KLS Martin Thoracic Plating System (K153482): The KLS Martin Thoracic Plating System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.
KLS Martin Cannulated Headless Screws (K161259): KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, arthrodeses, and nonunions of small bones in the hand, wrist, foot, and ankle.
Level One Hand Plating System (K170124): The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
KLS Martin Pure Pectus System (K221938): The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.
KLS Martin Level One Rib Fixation System (K222397): The KLS Martin Level One Rib Fixation System is indicated for use in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.
KLS Martin LINOS Wrist System (K222624): The KLS Martin LINOS Wrist System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

Device Description

The KLS Martin Sternal Plating System consists of titanium plates ranging in thickness from 1.0mm – 3.0mm and screws ranging in diameter from 2.3mm – 3.2mm.
The KLS Martin Hand Plating System consists of titanium plates ranging in thickness from 0.6mm – 3.0mm and screws ranging in diameter from 1.0mm – 2.7mm.
The KLS Martin Sternal Talon is a two-piece with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three-position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw. The KLS Martin Sternal Talon is manufactured from titanium alloy (Ti-6Al-4V).
The KLS Martin Sternal Talon (K051165) is a two-piece with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three-position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the KLS Martin Sternal Talon is manufactured from titanium alloy (T-6Al-4V). The KLS Martin Sternal Plating System (K032413) consists of titanium plates rom 1.0mm – 3.0mm and screws ranging in diameter from 2.3mm - 3.2mm. The screws are used to affix the plates to the sternum. Plate an elongated midsection to facilitate quick re-entry in subsequent thoracic procedures.
The KLS Martin Recon Talon is a two-piece clamping device, which has on either end an attached plate. Plate thickness ranges from 1.0mm to 3.0mm and screw diameter ranges from 2.2mm. The two-piece clamping device utilizes a ratcheted locking system. Each piece of the device is affixed to opposing sides of the sternum and interlocks to provide stablized fixation. The device has a threeposition screw, allowing the ratchet to open, close, and lock. In an emergency situation the device can be reopened by turning the screw to the open position. Secondary emergency re-entry is provided by cut points adjacent to the screw.
The LINOS MOH Hand Plating System consists of titanium plates ranging in thickness from 0.6mm – 3.0mm and screws ranging in diameter from 1.0mm – 2.7mm. Plate features include a low profile with anqulated-locking threaded screws are either locking or non-locking.
The KLS Martin LSS Plating System includes plates and screws that are in conjunction with stainless steel suture wire for midline sternal closure. The LSS plates, when applied, are used to reinforce the sternal halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK and offered in one size. The thickness from 2.1 mm – 2.5 mm (minimum – maximum dimensions) and are fixated using 2.3mm titanium screws. Once the sternum is reapproximated, the midline is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished by cutting the stainless steel suture wire.
The KLS Martin Thoracic Plating System includes metallic plates and screws that provide rigid fixation to fractures, and can be used for reconstructive procedures in the thoracic anatomy. The implants are available non-sterile in multiple shapes and sizes. Plates are manufactured from CP Titanium (ASTM F67:2013) and range in thickness from 1.0 – 3.0mm. Screws are manufactured from Ti-6Al-4V (ASTM F1362013) and range in diameter from 2.3 – 3.2mm with lengths from 7 – 17mm.
The KLS Martin Cannulated Headless Screws (CHS) system is comprised of headless cannulated screws intended for bone fixation in the treatment of fractures, non-unions, osteotomies, or to aid in small joint fusions of the hand, wrist, foot, and ankle. Bone fixation is achieved by proximal and distal threads designed with different pitches that, when inserted into the bone, cause compression of the bone fragments for bone reduction, stability, and healing. Cannulation of the user to inow the user to insert the screw over the guide wire for proper placement prior to compression. The CHS system offers screws in various diameters, overall lengths, and thread lengths to accommodate different sizes and types of bone reduction, such as scaphoid fractures and non-unions. The screws are self drilling and self-tapping to eliminate the need for do implantation. All screws are manufactured from Ti-6Al-4V (ASTM F136:2013).
The Level One (L1) Hand Plating System includes metallic plates, washers, and screws intended for small bone fixation. Plates are precontoured to accommodate patient anatomy, available in various shapes and range in thickness from 0.6mm - 3.0mm and are compatible with the standard and multidirectional locking screws offered in the system. Screws are self tapping, available in a standard or multidirectional locking configuration and range in diameter from 1.0mm - 2.7mm with lengths from 2mm - 32mm. Standard screws may be used alone or in conjunction with the washers or plates for small fragment osteosynthesis. Implants are manufactured from CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136).
The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pers that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are in multiple sizes and are manufactured using tradition methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also instruments to facilitate placement of the implants.
The KLS Martin Level One Rib Fixation System is comprised of PEEK plates and titanium locking screws intended to provide rigid fixation of bone in the thoracic anatomy. The PEEK plates are pre-contoured to accommodate patient anatomy and are offered in plate thicknesses of 2 mm - 3 mm. The PEEK plates are compatible with the Ti-6Al-4V (ASTM Fl 36) 2.3 mm x 7 mm multidirectional locking screws offered in the system. The plates are manufactured from PEEK (ASTM F2026). The system includes the necessary instrumentation to facilitate implantation.
The KLS Martin LINOS Wrist System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and/or corrective osteotomies of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V or CP Titanium. Plates are pre-contoured to accommodate patient anatomy and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants.

AI/ML Overview

The provided text discusses the KLS Martin Orthopedic Implants - MR Conditional device and the studies conducted to support its conditional safety in a Magnetic Resonance (MR) environment.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria (Hazard addressed)	Standard/Method	Reported Device Performance
Magnetically induced displacement force	ASTM F2052-21	Non-clinical testing provided to support conditional safety in MR environment. (Implied acceptability based on submission)
Magnetically induced torque	ASTM F2213-17	Non-clinical testing provided to support conditional safety in MR environment. (Implied acceptability based on submission)
Image artifacts	ASTM F2119-07, R2013	Non-clinical testing provided to support conditional safety in MR environment. (Implied acceptability based on submission)
RF-induced heating	ASTM F2182-19e2 (with Computational modeling and simulation)	Temperature rise below 6°C for an hour-long scanning session at a whole-body averaged specific absorption rate (wbSAR) of 2 W/kg (or head SAR for relevant regions).

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

The text does not specify a "test set" in the traditional sense of a clinical or observational study with a certain number of patients or cases. Instead, the performance evaluation is based on non-clinical testing and computational modeling and simulation (CM&S) of the devices themselves.

Sample size for non-clinical testing: The text refers to "the entire portfolio of KLS Martin thoracic and hand osteosynthesis implants." While not a specific number, it implies a comprehensive evaluation of the range of devices.
Data provenance: The studies are non-clinical, done ex-vivo (for some tests) and through simulation. The computational modeling utilized "MED Institute's FDA-qualified Medical Development Tool (MDDT) and in a clinically relevant position within the Duke virtual human anatomy." This suggests the data is generated through established scientific methods rather than patient data from a specific country or retrospective/prospective collection.

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 question is not applicable in the context of this submission. The "ground truth" for non-clinical testing and simulation is defined by the physical properties of the materials, the established testing standards (ASTM), and the validated computational models. There were no human experts establishing ground truth for evaluating the device's MR compatibility in the way radiology images would be reviewed.

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

This question is not applicable as there was no human adjudication of a clinical test set. The evaluation relies on standardized testing protocols and validated computational models.

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 question is not applicable. This submission is for the MR Conditional labeling of orthopedic implants, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

A "standalone" performance in the context of an algorithm is not applicable here. The computational modeling and simulation for RF-induced heating could be considered a form of "algorithm only" evaluation for a specific physical property of the device, but it is not an AI diagnostic algorithm. It's a scientific modeling approach to predict a physical outcome.

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

The ground truth for the non-clinical tests and simulations is based on:

Physical properties and behavior of materials according to established scientific principles.
Standardized test methods defined by ASTM (e.g., ASTM F2052-21, ASTM F2213-17, ASTM F2119-07, ASTM F2182-19e2).
FDA-qualified Medical Development Tool (MDDT) for computational modeling, implying its results are considered reliable and accurate.

8. The sample size for the training set

This question is not applicable as there is no mention of a "training set" in the context of artificial intelligence or machine learning. The studies described are non-clinical hardware tests and physics-based simulations, not data-driven AI model training.

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

This question is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/0 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 12, 2024

KLS-Martin L.P. Katie Ruthland Regulatory Affairs Project Manager 11201 Saint Johns Industrial Pkwy S Jacksonville, Florida 32246

Re: K241018

Trade/Device Name: KLS Martin Orthopedic Implants - MR Conditional Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, JDQ Dated: April 12, 2024 Received: April 15, 2024

Dear Katie Ruthland:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

Image /page/1/Picture/5 description: The image shows the word "Sincerely," followed by the name "Shumaya Ali-S". The text is written in a clear, legible font. The name is slightly larger than the salutation. The background is plain and white.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241018

Device Name

KLS Martin Orthopedic Implants - MR Conditional;

K032413: KLS Martin Sternal Plating System;

K040598: KLS Martin Hand Plating System;

K051165: KLS Martin Sternal Talon;

K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile;

K122860: Recon Talon :

K141489: LINOS MOH Hand Plating System :

K151983: KLS Martin LSS Plating System :

K153482: KLS Martin Thoracic Plating System ;

K161259: KLS Martin Cannulated Headless Screws;

K170124: Level One Hand Plating System ;

K221938: KLS Martin Pure Pectus System ;

K222397: KLS Martin Level One Rib Fixation System ;

K222624: KLS Martin LINOS Wrist System

Indications for Use (Describe)

KLS Martin Sternal Plating System (K032413):

The KLS Martin Sternal Plating System is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

KLS Martin Hand Plating System (K040598):

The KLS Martin Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

KLS Martin Sternal Talon (K051165):

The KLS Martin Sternal Talon is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternal reconstructive procedures.

KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile (K070169):

To offer KLS Martin Sternal Talon and KLS Martin Sternal Plating in sterile packaging with the following indications for use: K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Recon Talon (K122860):

The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternal reconstructive procedures.

LINOS MOH Hand Plating System (K141489):

The LINOS MOH Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

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KLS Martin LSS Plating System (K151983):

The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension.

KLS Martin Thoracic Plating System (K153482):

The KLS Martin Thoracic Plating System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.

KLS Martin Cannulated Headless Screws (K161259):

KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, arthrodeses, and nonunions of small bones in the hand, wrist, foot, and ankle.

Level One Hand Plating System (K170124):

The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

KLS Martin Pure Pectus System (K221938):

The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.

KLS Martin Level One Rib Fixation System (K222397):

The KLS Martin Level One Rib Fixation System is indicated for use in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.

KLS Martin LINOS Wrist System (K222624):

The KLS Martin LINOS Wrist System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

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)

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510(k) Summary

Prepared on: 2024-04-12

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	KLS-Martin L.P.
Applicant Address	11201 Saint Johns Industrial Pkwy S Jacksonville FL 32246 United States
Applicant Contact Telephone	904-641-7746
Applicant Contact	Ms. Melissa Bachorski
Applicant Contact Email	rapm_na@klsmartin.com
Correspondent Name	KLS-Martin L.P.
Correspondent Address	11201 Saint Johns Industrial Pkwy S Jacksonville FL 32246 United States
Correspondent Contact Telephone	904-641-7746
Correspondent Contact	Ms. Katie Rutland
Correspondent Contact Email	katie.rutland@klsmartin.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	KLS Martin Orthopedic Implants - MR Conditional;K032413: KLS Martin Sternal Plating System;K040598: KLS Martin Hand Plating System;K051165: KLS Martin Sternal Talon;K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plating System- Sterile;K122860: Recon Talon ;K141489: LINOS MOH Hand Plating System ;K151983: KLS Martin LSS Plating System ;K153482: KLS Martin Thoracic Plating System ;K161259: KLS Martin Cannulated Headless Screws;K170124: Level One Hand Plating System ;K221938: KLS Martin Pure Pectus System ;K222397: KLS Martin Level One Rib Fixation System ;K222624: KLS Martin LINOS Wrist System
Common Name	Single/multiple component metallic bone fixation appliances and accessories
Classification Name	Plate, Fixation, Bone
Regulation Number	888.3030
Product Code(s)		HRS, HWC, JDQ

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

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Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K032413	KLS Martin Sternal Plating System	HRS
K040598	KLS Martin Hand Plating System	HRS
K051165	KLS Martin Sternal Talon	HRS
K070169	KLS Martin Sternal Talon & KLS Martin Sternal Plating System	HRS
K122860	Recon Talon	HRS
K141489	LINOS MOH Hand Plating System	HRS
K151983	KLS Martin LSS Plating System	JDQ
K153482	KLS Martin Thoracic Plating System	HRS
K161259	KLS Martin Cannulated Headless Screws	HWC
K170124	Level One Hand Plating System	HRS
K221938	KLS Martin Pure Pectus System	HRS
K222397	KLS Martin Level One Rib Fixation System	HRS
K222624	KLS Martin LINOS Wrist System	HRS
Device Description Summary21 CFR 807.92(a)(4)

Device Description Summary

KLS Martin Sternal Plating System (K032413):

The KLS Martin Sternal Plating System consists of titanium plates ranging in thickness from 1.0mm – 3.0mm and screws ranging in diameter from 2.3mm – 3.2mm.

KLS Martin Hand Plating System (K040598):

The KLS Martin Hand Plating System consists of titanium plates ranging in thickness from 0.6mm – 3.0mm and screws ranging in diameter from 1.0mm – 2.7mm.

KLS Martin Sternal Talon (K051165):

The KLS Martin Sternal Talon is a two-piece with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three-position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw. The KLS Martin Sternal Talon is manufactured from titanium alloy (Ti-6Al-4V).

KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile (K070169):

The KLS Martin Sternal Talon (K051165) is a two-piece with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three-position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the KLS Martin Sternal Talon is manufactured from titanium alloy (T-6Al-4V). The KLS Martin Sternal Plating System (K032413) consists of titanium plates rom 1.0mm – 3.0mm and screws ranging in diameter from 2.3mm - 3.2mm. The screws are used to affix the plates to the sternum. Plate an elongated midsection to facilitate quick re-entry in subsequent thoracic procedures.

Recon Talon (K122860):

The KLS Martin Recon Talon is a two-piece clamping device, which has on either end an attached plate. Plate thickness ranges from

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1.0mm to 3.0mm and screw diameter ranges from 2.2mm. The two-piece clamping device utilizes a ratcheted locking system. Each piece of the device is affixed to opposing sides of the sternum and interlocks to provide stablized fixation. The device has a threeposition screw, allowing the ratchet to open, close, and lock. In an emergency situation the device can be reopened by turning the screw to the open position. Secondary emergency re-entry is provided by cut points adjacent to the screw.

LINOS MOH Hand Plating System (K141489):

The LINOS MOH Hand Plating System consists of titanium plates ranging in thickness from 0.6mm – 3.0mm and screws ranging in diameter from 1.0mm – 2.7mm. Plate features include a low profile with anqulated-locking threaded screws are either locking or non-locking.

KLS Martin LSS Plating System (K151983):

The KLS Martin LSS Plating System includes plates and screws that are in conjunction with stainless steel suture wire for midline sternal closure. The LSS plates, when applied, are used to reinforce the sternal halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK and offered in one size. The thickness from 2.1 mm – 2.5 mm (minimum – maximum dimensions) and are fixated using 2.3mm titanium screws. Once the sternum is reapproximated, the midline is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished by cutting the stainless steel suture wire.

KLS Martin Thoracic Plating System (K153482):

The KLS Martin Thoracic Plating System includes metallic plates and screws that provide rigid fixation to fractures, and can be used for reconstructive procedures in the thoracic anatomy. The implants are available non-sterile in multiple shapes and sizes. Plates are manufactured from CP Titanium (ASTM F67:2013) and range in thickness from 1.0 – 3.0mm. Screws are manufactured from Ti-6Al-4V (ASTM F1362013) and range in diameter from 2.3 – 3.2mm with lengths from 7 – 17mm.

KLS Martin Cannulated Headless Screws (K161259):

The KLS Martin Cannulated Headless Screws (CHS) system is comprised of headless cannulated screws intended for bone fixation in the treatment of fractures, non-unions, osteotomies, or to aid in small joint fusions of the hand, wrist, foot, and ankle. Bone fixation is achieved by proximal and distal threads designed with different pitches that, when inserted into the bone, cause compression of the bone fragments for bone reduction, stability, and healing. Cannulation of the user to inow the user to insert the screw over the guide wire for proper placement prior to compression. The CHS system offers screws in various diameters, overall lengths, and thread lengths to accommodate different sizes and types of bone reduction, such as scaphoid fractures and non-unions. The screws are self drilling and self-tapping to eliminate the need for do implantation. All screws are manufactured from Ti-6Al-4V (ASTM F136:2013).

Level One Hand Plating System (K170124):

The Level One (L1) Hand Plating System includes metallic plates, washers, and screws intended for small bone fixation. Plates are precontoured to accommodate patient anatomy, available in various shapes and range in thickness from 0.6mm - 3.0mm and are compatible with the standard and multidirectional locking screws offered in the system. Screws are self tapping, available in a standard or multidirectional locking configuration and range in diameter from 1.0mm - 2.7mm with lengths from 2mm - 32mm. Standard screws may be used alone or in conjunction with the washers or plates for small fragment osteosynthesis. Implants are manufactured from CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136).

KLS Martin Pure Pectus System (K221938):

The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pers that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are in multiple sizes and are manufactured using tradition methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also instruments to facilitate placement of the implants.

KLS Martin Level One Rib Fixation System (K222397):

The KLS Martin Level One Rib Fixation System is comprised of PEEK plates and titanium locking screws intended to provide rigid fixation of bone in the thoracic anatomy. The PEEK plates are pre-contoured to accommodate patient anatomy and are offered in plate thicknesses of 2 mm - 3 mm. The PEEK plates are compatible with the Ti-6Al-4V (ASTM Fl 36) 2.3 mm x 7 mm multidirectional locking screws offered in the system. The plates are manufactured from PEEK (ASTM F2026). The system includes the necessary instrumentation to facilitate implantation.

KLS Martin LINOS Wrist System (K222624):

The KLS Martin LINOS Wrist System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and/or corrective osteotomies of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V or CP Titanium. Plates are pre-contoured to accommodate patient anatomy and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants.

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Intended Use/Indications for Use

21 CFR 807.92(a)(5)

KLS Martin Sternal Plating System (K032413):

The KLS Martin Sternal Plating System is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

KLS Martin Hand Plating System (K040598):

The KLS Martin Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

KLS Martin Sternal Talon (K051165):

The KLS Martin Sternal Talon is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile (K070169):

To offer KLS Martin Sternal Talon and KLS Martin Sterile packaging with the following indications for use: K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternal reconstructive procedures.

Recon Talon (K122860):

The KLS Martin Recon Talon is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

LINOS MOH Hand Plating System (K141489):

The LINOS MOH Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

KLS Martin LSS Plating System (K151983):

KLS Martin Thoracic Plating System (K153482):

The KLS Martin Thoracic Plating System is indication and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.

KLS Martin Cannulated Headless Screws (K161259):

KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, arthrodeses, and nonunions of small bones in the hand, wrist, foot, and ankle.

Level One Hand Plating System (K170124):

The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

KLS Martin Pure Pectus System (K221938):

The KLS Martin Pure Pectus System is indical for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.

KLS Martin Level One Rib Fixation System (K222397):

The KLS Martin Level One Rib Fixation System is in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.

KLS Martin LINOS Wrist System (K222624):

The KLS Martin LINOS Wrist System is indicated for use in forearm fractures, and arthrodeses. It is intended for adults, and children (2-12 years) and adolescents (12-21 years) in which growth plates will not be crossed by fixation.

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use for the subject and predical. The basis of this submission is to support the conditional safety and labeling modification of the subject device, KLS Martin Orthopedic Implants – MR Conditional, in the magnetic resonance environment.

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Technological Comparison

The subject and predicate devices share identical technological characteristics which were previously evaluated in each predicate device included in this bundled submission. There have been no significant changes to the previously cleared devices that would impact safety and effectiveness with regard to design, mechanical and engineering performance, manufacturing processes, materials, sterility, packaging and shelf life, and biocompatibility.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-clinical testing has been provided to support the conditional safety of the MR environment. Hazards addressed include magnetically induced displacement force (ASTM F2052-21) and torque (ASTM F2213-17), image artifacts (ASTM F2119-07, R2013), and RF-induced heating (ASTM F2182-19e2).

Not Applicable

Computational modeling and simulation (CM&S) was used to estimate ex-vivo temperature rise due to RF-induced heating for the entire portfolio of KLS Martin thoracic and hand osteosynthesis implants, which is the focus of this pre-submission. Simulations of RF-induced heating at 1.5 T/64 MHz were conducted in lieu of physical testing according to ASTM F2182-19e2 using MED Institute's FDA-qualified Medical Development Tool (MDDT) and in a clinically relevant position within the Duke virtual human anatomy. Various in-vivo device positions and landmarks of the Duke virtual human anatomy with the worst-case single and multiple devices were then simulated in 10 cm increments in each MRI system to determine the worst-case scenario for in-vivo RFinduced heating. The worst-case device, in-vivo position for each MRI system for in-vivo RF-induced heating at a whole-body averaged specific absorption rate (wbSAR) of 2 W/kg are determined. Fractional wbSAR or head SAR for an hour-long scanning session while maintaining a temperature rise of below 6 °C were determined for the worst-case devices within the Duke (Tables 3 to 12 in the test report) to align with the most recent FDA quidance document for testing and labeling of medical devices for safety in the magnetic resonance environment. Scanning conditions for anatomical regions that can be safely scanned for an hour of continuous RF at wbSAR of 2 W/kg were also determined. Therefore, the devices listed in the KLS Martin Orthopedic portfolio can be safely scanned under the conditions presented in the labeling.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.