(267 days)
No
The description focuses on the mechanical properties and materials of the plates and screws, and the performance studies are bench tests comparing mechanical equivalence to a predicate device. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is an orthopedic implant for internal fixation, alignment, and stabilization of forearm fractures, which aligns with the definition of a therapeutic device.
No
The device is an orthopedic implant system designed for internal fixation, alignment, and stabilization of forearm fractures, not for diagnosing medical conditions.
No
The device description explicitly states it consists of metallic plates, bone screws, locking pins, and instruments, which are all hardware components.
Based on the provided information, the KLS Martin LINOS Wrist System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The KLS Martin LINOS Wrist System is a surgical implant used for the internal fixation, alignment, and stabilization of forearm fractures, osteotomies, and arthrodeses. It is a physical device implanted into the body, not used to test biological samples.
The description clearly indicates it's a system of metallic plates, screws, and pins for surgical procedures on the forearm. This falls under the category of surgical implants or orthopedic devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
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, reconstructive 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forearm fractures, osteotomies, and arthrodeses (specifically distal radius and/or ulna)
Indicated Patient Age Range
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.
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Comparative head-to-head static and dynamic bench testing was conducted on the subject and predicate (Medartis AG APTUS Wrist 2.5 System (KI 42906)) devices to determine that the subject device has equivalent performance to the primary predicate. Additionally, comparative screw testing was performed to evaluate torsional strength, drive torque, and pullout strength in accordance with ASTM F543. Mechanical test results demonstrate that the KLS Martin LINOS Wrist System's performance is substantially equivalent to the primary predicate device. Biological safety risk assessments in compliance with ISO 10993-1 :2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use. The gamma sterilization process for the sterile implants and instrumentation/accessories was validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2012 using the VDmax25 method. The validation was also in accordance with ISO 11737-1:2018 and ISO 11737-2:2019. The dynamic-air-removal steam sterilization cycle parameters for the non-sterile implants and non-sterile instrumentation/accessories were validated in accordance with ISO 17665-1 :2006/(R)2013. Shelf life for all gamma sterilized components is five (5) years from the date of sterilization. LAL endotoxin testing was conducted to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications in accordance with AAMI ANSI ST72: 2019. Packaging validations were performed for the PETG blister pack with 1073B Tyvek cover in accordance with ISO 11607-1:2019, ISO 11607-2:2019, and ASTM D4169:2016. Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K171624, K170124, K110 125, K191972
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 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.
0
May 25, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
KLS-Martin L.P. Liza Gordillo Regulatory Affairs Project Manager 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246
Re: K222624
Trade/Device Name: KLS Martin LINOS Wrist System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: April 25, 2023 Received: April 25, 2023
Dear Liza Gordillo:
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
1
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,
Shumaya Ali-S
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
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
KLS Martin LINOS Wrist System
Indications for Use (Describe)
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) #: K222624
510(k) Summary
Prepared on: 2023-05-25
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 | 800-625-1557 | |
| 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 | 800-625-1557 | |
| Correspondent Contact | Ms. Liza Gordillo | |
| Correspondent Contact Email | liza.gordillo@klsmartin.com | |
| Device Name | ||
| 21 CFR 807.92(a)(2) | ||
| Device Trade Name | KLS Martin LINOS Wrist System | |
| Common Name | Plate, Fixation, Bone (primary); Screw, Fixation, Bone | |
| Classification Name | Single/multiple component metallic bone fixation appliances and | |
| accessories (primary) | ||
| Smooth or threaded metallic bone fixation fastener | ||
| Regulation Number | 888.3030 (primary) / 888.3040 | |
| Product Code | HRS (primary) / HWC | |
| Legally Marketed Predicate Devices | ||
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K142906 | APTUS® Wrist 2.5 System | HRS |
| K171624 | IXOS Radius Plate System (Reference Device) | HRS |
| K170124 | KLS Martin Level One Hand Plating System (Reference Device) | HRS |
| K110 125 | 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM (Refere | HRS |
4
VariAx 2 System, VariAx 2 Mini Fragment System (Reference Da
HRS
HRS
K191972
ARIX Wrist System (Reference Device)
Device Description Summary
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, reconstructive 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.
Intended Use/Indications for Use
The KLS Martin LINOS Wrist System is indicated for use in forearm fractures, and arthrodeses. It is intended for adults, and children (2-12 vears) and adolescents (12-21 years) in which growth plates will not be crossed by fixation.
Indications for Use Comparison
The intended use of the subject device is identical to the primary predicate device, APTUS® Wrist 2.5 System (K142906). The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and validation testing.
Technological Comparison
Similarities to Predicates
The subject and predicate devices, as well as the reference devices, have the same fundamental technologies in that they are all designed for use in surgical procedures of the hand and forearm region and are manufactured in a variety of sizes and configurations to provide the physician with various sizing options to repair hand and forearm fractures, osteotomies, and arthrodeses.
Differences from Predicate
The subject device is manufactured from CP titanium (ASTM F67:2017) and Ti-6Al-4V (ASTM F136:2013), while the predicate device, K142906, is manufactured from CP titanium (ASTM F67:2017), the reference device, K171624, is made of CP titanium (ASTM F67:2017) and the reference device, K170124, is made of both CP titanium (ASTM F136:2017) and Ti-6Al-4V (ASTM F136:2013). Performance testing demonstrated that the differences in material does not affectiveness of the subject devices and can be determined substantially equivalent.
Conclusion
Based on the questions above as well as conformance to FDA-recognized standards, along with the performance data compared with the predicate, K142906, safety and effectiveness has been demonstrated.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-Clinical Performance Data
Comparative head-to-head static and dynamic bench testing was conducted on the subject and predicate (Medartis AG APTUS Wrist 2.5 System (KI 42906)) devices to determine that the subject device has equivalent performance to the primary predicate. Additionally, comparative screw testing was performed to evaluate torsional strength, drive torque, and pullout strength in accordance with ASTM F543. Mechanical test results demonstrate that the KLS Martin LINOS Wrist System's performance is substantially equivalent to the primary predicate device. Biological safety risk assessments in compliance with ISO 10993-1 :2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use.
The gamma sterilization process for the sterile implants and instrumentation/accessories was validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2012 using the VDmax25 method. The validation was also in accordance with ISO 11737-1:2018 and ISO 11737-2:2019. The dynamic-air-removal steam sterilization cycle parameters for the non-sterile implants and non-sterile instrumentation/accessories were validated in accordance with ISO 17665-1 :2006/(R)2013.
Shelf life for all gamma sterilized components is five (5) years from the date of sterilization.
LAL endotoxin testing was conducted to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications in accordance with AAMI ANSI ST72: 2019.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(4)
5
Packaging validations were performed for the PETG blister pack with 1073B Tyvek cover in accordance with ISO 11607-1:2019, ISO 11607-2:2019, and ASTM D4169:2016
Clinical Performance Data
Clinical testing was not necessary for the determination of substantial equivalence.
Conclusions
The KLS Martin LINOS Wrist System has the same intended use and similar technological characteristics as the predicate device and reference devices. Technological differences have been addressed through performance data from the predicate and reference devices, in addition to analysis of peer-reviewed clinical studies. All information provided show the safe and effective use of the subject device for the intended patient population.
In conclusion, the potential benefits associated with the use of the subject device outweigh its potential risks for the targeted patient population. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.