(125 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of metallic plates and screws for bone fixation, with no mention of software, algorithms, or AI/ML capabilities.
No
The device provides rigid fixation for fractures and osteotomies in the chest wall, which is a supportive and structural function rather than a direct therapeutic action.
No
Explanation: The device is described as a Thoracic Plating System used for fixation of fractures and reconstructive procedures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it includes metallic plates, screws, and instruments, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The KLS Martin Thoracic Plating System is described as a system of metallic plates and screws used for the fixation of fractures and reconstructive procedures in the chest wall. This is a surgical implant used directly on the patient's body, not for testing samples outside the body.
The information provided clearly indicates this is a surgical device for internal fixation, not an IVD.
N/A
Intended Use / Indications for Use
The KLS Martin Thoracic Plating System is indication and fixation of fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The KLS Martin Thoracic Plating System includes metallic plates and screws that provide rigid fixation to fractures, planned osteotomies, and can be used for reconstructive procedures in the thoracic anatomy. The implants are available non-sterile or 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 F136:2013) and range in diameter from 2.3 - 3.2mm with lengths from 7 - 17mm. 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
chest wall, sternal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Static and dynamic 4-point bending tests were performed in accordance with ASTM F382. The strength properties of the subject plates were compared against the predicate plates. Results met or exceeded the defined test conditions and demonstrate that the performance of the subject plates is substantially equivalent to the predicate devices. 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.
Biomet Microfixation Thoracic Fixation System (K142823), KLS-Martin Sternal Plating System (K032413 / K070169), KLS Martin Recon Talon (K122860)
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.
Not Found
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2016
KLS-Martin L.P. Mr. Gary Moore Quality Management and Regulatory Affairs Manager 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K153482
Trade/Device Name: KLS Martin Thoracic Plating 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: March 3, 2016 Received: March 8, 2016
Dear Mr. Moore:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
KLS Martin Thoracic Plating System
Indications for Use (Describe)
The KLS Martin Thoracic Plating System is indication and fixation of fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The words "KLS" are in red, "martin" is in gray, and "L.P." is in black. The logo is simple and modern, and it is likely used to represent the company in a variety of contexts.
1201 Saint Johns Industrial Pkwy S . Jacksonville, FL 32246 hone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 w.klsmartinnorthamerica.com
Section 5 510(k) Summary 21 CFR 807.92
| Submitter: | KLS Martin LP
11201 Saint Johns Industrial Pkwy S.
Jacksonville, FL 32246 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director of Quality MGT & Regulatory Affairs
Phone: 800-625-1557
Fax: 904-641-7378 |
| Date Prepared: | April 4, 2016 |
| Trade Name: | KLS Martin Thoracic Plating System |
| Common Name: | Plate, Fixation, Bone |
| Classification: | Single/multiple component metallic bone fixation appliances
and accessories
Class II, 21 CFR 888.3030, Product Code HRS |
| Predicates: | Biomet Microfixation Thoracic Fixation System (K142823)
KLS-Martin Sternal Plating System (K032413 / K070169)
KLS Martin Recon Talon (K122860) |
Device Description:
The KLS Martin Thoracic Plating System includes metallic plates and screws that provide rigid fixation to fractures, planned osteotomies, and can be used for reconstructive procedures in the thoracic anatomy. The implants are available non-sterile or 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 F136:2013) and range in diameter from 2.3 - 3.2mm with lengths from 7 - 17mm. The system also includes the necessary instruments to facilitate placement of the implants.
Indications for Use:
The KLS Martin Thoracic Fixation 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.
Contraindications: 1. Active Infection. 2. Not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical or lumbar spine. 3. Patient conditions including: blood supply limitations, insufficient quantity of bone or latent infections. 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 5. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
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Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The logo is composed of three parts: "KLS" in red, "martin" in gray, and "L.P." in black. The letters are bold and sans-serif.
Substantial Equivalence Discussion:
Similarities to Predicate Devices
The subject and predicate devices include metallic plates and screws intended to provide rigid fixation of bone in the thoracic anatomy. All implant systems are manufactured from CP Titanium and Ti-6A1-4V and are implanted using the same method of fixation. The subject device incorporates locking plate and screw characteristics similar to the KLS Martin Recon Talon - K122860, and undergoes identical manufacturing and sterilization processes as the KLS Martin Recon Talon - K122860 and the KLS-Martin Sternal Plating System - K032413 / K070169.
Differences to Predicate Devices
The subject device offers implants in sterile packaging and additional plate shapes from the primary predicate. Biomet Microfixation Thoracic Fixation System - K142823. The subject device differs from the KLS Martin Recon Talon - K122860 and KLS-Martin Sternal Plating - K032413 / K070169 with expanded indications for use in lateral and posterior chest wall fixation and includes additional plate shapes for rib fractures.
Non-Clinical Performance Data:
Static and dynamic 4-point bending tests were performed in accordance with ASTM F382. The strength properties of the subject plates were compared against the predicate plates. Results met or exceeded the defined test conditions and demonstrate that the performance of the subject plates is substantially equivalent to the predicate devices.
Clinical Performance Data:
Clinical testing was not necessary for the determination of substantial equivalence.
Conclusion:
The KLS Martin Thoracic Plating System has the same intended use, same principles of operation, and similar technological features compared to the predicate devices. Any differences in technological features between the subject and predicate devices do not raise different questions of safety and effectiveness. The non-clinical performance data presented supports substantial equivalence of the KLS Martin Thoracic Plating System to the predicate devices.