(49 days)
No
The description focuses on mechanical components (plates, screws, instruments) and mechanical testing, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is used for "stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones," which indicates a therapeutic purpose.
No
This device is a surgical plating system used for the stabilization and fixation of fractures and offers a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of plates, screws, and instruments, which are physical hardware components used for surgical procedures.
Based on the provided information, the LINOS MOH Hand Plating System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones...". This describes a surgical implant used directly on the patient's body for structural support and repair.
- Device Description: The description details plates, screws, and instruments used for bone fixation. These are physical devices implanted during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the LINOS MOH Hand Plating System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
Product codes
HRS
Device Description
The LINOS MOH Hand Plating System consists of plates of various shapes and thicknesses for bone fixation. Plate features include a low profile with angulated-locking threaded screw holes. The system also includes locking and non-locking screws of various lengths and diameters and the necessary instruments to facilitate placement of the implants. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the existing plates and screws in the previously cleared KLS Martin Hand Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones of the hand, wrist, fingers, feet, ankles, toes
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)
Mechanical testing was conducted according to ASTM F382-99 and ASTM F543-13, which demonstrated the subject devices met performance requirements and are as safe and effective as their predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KLS Martin Hand Plating System (K040598)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for KLS Martin LP. The letters "KLS" are in bold black font, while "martin" is in a white font with a black outline. The letters "LP" are in bold black font, similar to the "KLS".
P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartin.com
K141489 (pg 1/3)
Special 510(k) Summarv Section 21 CFR 807.92
JUL 2 4 2014
| Submitter: | KLS Martin L.P.
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director of Quality Mgt and Regulatory Affairs
Phone: 800-625-1557
Fax: 904-641-7378 |
| Date Prepared: | June 2, 2014 |
| Trade Name: | LINOS MOH Hand 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 |
| Predicate Devices: | KLS Martin Hand Plating System (K040598) |
Device Description:
The LINOS MOH Hand Plating System consists of plates of various shapes and thicknesses for bone fixation. Plate features include a low profile with angulated-locking threaded screw holes. The system also includes locking and non-locking screws of various lengths and diameters and the necessary instruments to facilitate placement of the implants. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the existing plates and screws in the previously cleared KLS Martin Hand Plating System.
Intended Use:
The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes. This is the same intended use as previously cleared for the KLS Martin Hand Plating System, K040598.
1
| .
1
| Acres of anywood on the Artist of the first on |
|---|
| com |
| C |
| Seam |
| TTT |
| म की |
- Partice Participant Participant Property
Status Career States
R |
P.O. Box 16369 ● Jacksonville, FL 32245-6369
904-641-7746 or 800-625-1557 • Fax 904-641-7378
www.klsmartin.com
echnological Characteristics/Substantial Equivalence
| | LINOS MOH Hand Plating System | KLS Martin Hand Plating System - Primary Predicate
(K040598) |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LINOS MOH Hand Plating System is used for stabilization
and fixation of fractures, revision procedures, joint fusion and
reconstruction of small bones of the hand, wrist, fingers, feet,
ankles and toes. | The KLS Martin Hand Plating System is used for stabilization
and fixation of fractures, revision procedures, joint fusion and
reconstruction of small bones of the hand, wrist, fingers, feet,
ankles and toes. |
| Anatomical Sites | Small bones of the hand, wrist, fingers, feet, ankles, toes | Small bones of the hand, wrist, fingers, feet, ankles, toes |
| Material | CP Titanium or Ti-6Al-4V Titanium Alloy | CP Titanium or Ti-6Al-4V Titanium Alloy |
| Plate Geometry | Pre-curved to follow the natural curves of the hand and feet bones | Pre-curved to follow the natural curves of the hand and feet bones |
| Sterilization | Provided Nonsterile (Steam) | Provided Nonsterile (Steam) |
| Plate Thickness | 0.6mm – 3.0mm | 0.6mm – 3.0mm |
| Screw Diameter | 1.0mm – 2.7mm | 1.0mm – 2.7mm |
| Screw Length | 2mm – 32mm | 2mm – 32mm |
| Screw Style | smartDrive® (locking and non-locking) | Centre-Drive® (non-locking) |
| Plate Style | Threaded and Non-Threaded | Non-Threaded |
5-2
2
Image /page/2/Picture/0 description: The image shows the text "KLS martin LP." in a stylized font. The letters "KLS" and "LP" are solid black, while the letters "martin" are outlined in black with a stippled fill. The text appears to be a logo or brand name.
P.O. Box 16369 · Jacksonville. FL 32245-6369 904-641-7746 or 800-625-1557 · Fax 904-641-7378 www.klsmartin.com
K141489 (pg 3/3)
Nonclinical Testing:
A risk analysis was performed in accordance with ISO 14971:2007, "Medical Devices Application of Risk Management to Medical Devices. The evaluation demonstrated that the design change did not present any hazards outside the criteria of acceptability and any risk-related issues were controlled and verified during the design control review process. The same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate, K040598.
Mechanical testing was conducted according to ASTM F382-99 and ASTM F543-13, which demonstrated the subject devices met performance requirements and are as safe and effective as their predicate devices.
Substantial Equivalence Conclusion:
The LINOS MOH Hand Plating System has the same intended use, function, specifications, and is identical in materials and manufacturing processes as the predicate, the KLS Martin Hand Plating System. The LINOS MOH Hand Plating System differs from the predicate in that the product line will be expanded to include screws in non-locking and locking configurations with an updated screw head. The similarities in technological characteristics do not raise new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate device.
3
Public Health Service
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles a human figure embracing or protecting another figure, which is a common representation of health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2014
KLS Martin L.P. Ms. Jennifer Damato Director of Quality Management and Regulatory Affairs 11201 Saint John Industrial Parkway South Jacksonville, Florida 32246
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K141489
Trade/Device Name: LINOS MOH Hand Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Sing/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: June 26, 2014 Received: June 27, 2014
Dear Ms. Damato:
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
4
Page 2 - Ms. Jennifer Damato
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
SECTION 4
510(k) Number (if known):
K141489 (pg 1/1)
LINOS MOH Hand Plating System Device Name:
Indications for Use:
The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures. revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet前站 - Frank - S
Division of Orthopedic Devices