KLS Martin Orthopedic Implants - MR Conditional

K241018 · KLS-Martin L.P. · HRS · Jul 12, 2024 · Orthopedic

Device Facts

• Record ID: K241018
• Device Name: KLS Martin Orthopedic Implants - MR Conditional
• Applicant: KLS-Martin L.P.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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. 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. 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. 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. 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. 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. 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. 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 are intended for the treatment of fractures, osteotomies, arthrodeses, and nonunions of small bones in the hand, wrist, foot, and ankle. 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. 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. 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. 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 Story

Portfolio of metallic bone fixation implants (plates, screws, talons, pectus bars) for thoracic and small bone orthopedic procedures; implants provide rigid fixation/stabilization of fractures or osteotomies. Subject submission updates labeling to MR Conditional status. Devices are used in clinical/surgical settings by surgeons. Input: patient anatomy; Output: mechanical stabilization of bone fragments. Benefit: enables safe MRI scanning for patients with existing implants. No changes to device design, materials, or manufacturing; safety established via computational modeling and simulation (CM&S) of RF-induced heating, displacement, and torque in MRI environments.

Clinical Evidence

No clinical data. Bench testing and computational modeling (CM&S) only. Simulations performed using FDA-qualified MDDT in Duke virtual human anatomy to assess RF-induced heating, displacement force, and torque per ASTM F2052-21, F2213-17, F2119-07, and F2182-19e2. Results confirm safety under specified MRI conditions.

Technological Characteristics

Materials: CP Titanium (ASTM F67), Ti-6Al-4V (ASTM F136), PEEK (ASTM F2026). Components: Plates, screws, talons, bars. Principle: Mechanical bone fixation/stabilization. Connectivity: N/A. Sterilization: Not specified (implants previously cleared).

Indications for Use

Indicated for stabilization/fixation of chest wall fractures, sternal reconstruction, sternotomy closure, pectus excavatum repair, and small bone fractures/fusions (hand, wrist, foot, ankle). Patient populations include adults and pediatric patients (varies by system; some restricted to 18+ or specific age ranges where growth plates are fused/not crossed).

Regulatory Classification

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.

Predicate Devices

• KLS Martin Sternal Plating System (K032413)
• KLS Martin Hand Plating System (K040598)
• KLS Martin Sternal Talon (K051165)
• KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile (K070169)
• Recon Talon (K122860)
• LINOS MOH Hand Plating System (K141489)
• KLS Martin LSS Plating System (K151983)
• KLS Martin Thoracic Plating System (K153482)
• KLS Martin Cannulated Headless Screws (K161259)
• Level One Hand Plating System (K170124)
• KLS Martin Pure Pectus System (K221938)
• KLS Martin Level One Rib Fixation System (K222397)
• KLS Martin LINOS Wrist System (K222624)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 | [e-mail] | |
| 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 | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | KLS Martin Orthopedic Implants - MR Conditional;<br>K032413: KLS Martin Sternal Plating System;<br>K040598: KLS Martin Hand Plating System;<br>K051165: KLS Martin Sternal Talon;<br>K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plating System<br>- Sterile;<br>K122860: Recon Talon ;<br>K141489: LINOS MOH Hand Plating System ;<br>K151983: KLS Martin LSS Plating System ;<br>K153482: KLS Martin Thoracic Plating System ;<br>K161259: KLS Martin Cannulated Headless Screws;<br>K170124: Level One Hand Plating System ;<br>K221938: KLS Martin Pure Pectus System ;<br>K222397: KLS Martin Level One Rib Fixation System ;<br>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 Summary<br>21 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):

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 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.