(66 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used for stabilization and fixation of fractures, not for therapeutic treatment.
No
Explanation: This device is described as a plating system used for the stabilization and fixation of fractures and reconstruction of small bones. Its function is to treat or repair, not to diagnose a condition.
No
The device description explicitly states it consists of physical plates and screws, which are 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. These tests are performed outside of the body.
- Device Description and Intended Use: The KLS Martin Hand Plating System is described as a system of plates and screws used for the stabilization and fixation of fractures and other bone procedures. This is a surgical implant used within the body to physically support and repair bone structures.
The function of this device is entirely mechanical and surgical, not diagnostic based on analyzing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The KLS Martin Hand Plating System consists of plates of various lengths and thickness from 0.6mm to 3.0mm and screws of various lengths having a diameter of 1.0mm to 2.7mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, fingers, feet, ankles and 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)
Not Found
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.
K961497, K992961, K011118, K032442, K944565, K944561
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.
0
MAY 1 3 2004
040598
page 1 of 2
510(K) SUMMARY
Submitter:
KLS-Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246 Phone: 904-641-7746 904-641-7378 Fax:
Contact Person:
Date of Summary
Device Name:
Trade Name:
Common Name:
Classification Name and Number:
Regulatory Class:
Predicate Devices:
Device Description:
Director RA/QA March 5th, 2004 KLS Martin Hand Plating System
Hand Plating System
Jennifer Damato
Small Bone Plating System
Sinale/Multiple Component Metallic Bone Fixation Appliances and Accessories (CFR 888.3030)
Class II
Profyle™ Titanium Hand and Small Fragment System (K961497)
Lorenz Small Fragment System (K992961)
Titanium Small Normed Extremity Hand and Fragment System (K011118)
Mandibular Fracture/Reconstruction Kre Martin System II (K032442)
Micro Osteosythesis System(1.5mm) KLS-Martin (K944565)
Micro Osteosynthesis System (1.0mm)(K944561)
The KLS Martin Hand Plating System consists of plates of various lengths and thickness from 0.6mm to 3.0mm and screws of various lengths having a diameter of 1.0mm to 2.7mm.
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K040598
page 2 of 2
Intended Use:
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.
Technological Characteristics:
Similarities to Predicate
Plates and screws of the KLS Martin Hand Plating System are similar to the Profyle " Titanium Hand and Small Fragment System (K961497), Lorenz Small Fragment System (K992961), Normed Extremity Titanium Hand and Small Fragment System (K011118).
Plates and screws of the KLS Martin Hand Plating System are identical in materials and manufacturing processes to the KLS Martin Mandibular Fracture/Reconstruction System II (K032442), KLS-Osteosythesis System(1.5mm) Micro Martin (K944565) and the Micro Osteosynthesis System (1.0mm)(K944561).
Plates and screws are either commercially pure (CP) titanium, or Ti-6AL-4V Titanium Alloy.
Differences to Predicate
The KLS Martin Hand Plating System contains plates that are pre-curved to follow the natural curves of the bones of the hand and feet. These plates are different in shape to the KLS Martin Mandibular Fracture/Reconstruction System II (K032442) KLS-Osteosythesis System(1.5mm) Martin Micro (K944565) and the Micro Osteosynthesis System (1.0mm)(K944561) but are of identical materials and manufacturing procedures.
The KLS Martin Hand Plating System contains 1.5mm screws that have a head that has a larger diameter Micro Osteosythesis than the KLS-Martin System(1.5mm) (K944565) but are of identical materials and manufacturing procedures.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three wing-like shapes, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Jennifer Damato Director Regulatory Affairs and Quality Assurance KLS Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K040598
Trade/Device Name: KLS Martin Hand Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 05, 2004 Received: March 08, 2004
Dear Ms. Damato:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use barea in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the to they 2011-07-11 accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). and Cosment Fee (110) and the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general vehicle wing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 adviscd 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 or any I outher all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2 - Jennifer Damato
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your e FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you doon's five of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
R. Mark A. Mellon
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
4
Indications for Use
510(k) Number (if known): K040598
KLS Martin Hand Plating System Device Name:
Indications For Use: 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Condurrene CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040598
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