(301 days)
Not Found
No
The summary describes a resorbable plating system for craniofacial fractures, consisting of screws, plates, and meshes made of PDLLA. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The focus is on the material and mechanical properties of the fixation system.
No.
A therapeutic device is one that treats a disease or condition. This device is used to fixate bone fractures and assist in reconstructive procedures, which are mechanical interventions rather than direct treatments of a disease state.
No
Explanation: The KLS-Martin Resorb-X System is described as a resorbable plating system intended for the fixation of fractures and reconstructive procedures of the craniofacial skeleton. It consists of screws, plates, and meshes, which are all components used in surgical intervention rather than for diagnosis.
No
The device description clearly states it consists of screws, plates, and meshes made of Poly (D. L)-Lactid-Acid (PDLLA), which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- KLS-Martin Resorb-X System Function: The KLS-Martin Resorb-X System is a surgical implant used to fixate fractures and reconstruct the craniofacial skeleton. It is physically implanted into the patient's body.
The description clearly indicates that this device is used in vivo (within the body) for structural support and fixation, not for testing biological samples.
N/A
Intended Use / Indications for Use
The KLS-Martin Resorb-X System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton.
The KLS-Martin Resorb-X System is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The KLS-Martin Resorb-X resorbable plating system consists of all necessary Instrumentation to employ three diameters of screws with associated plates and meshes. The screws are Poly (D. L)-Lactid-Acid (PDLLA) and are available in diameters 1.6mm, 2.1mm and 2.4mm. The plates and meshes are the same material and vary in shape, size and thickness, and may be used with any of the above diameter screws to fixate.
The screws and plates are provided pre-sterilized by gamma irradiation and are not intended to be resterilized by the end user.
The screws are not intended to be used without a plate.
The screws require a pilot hole and this pilot hole must be tapped.
The plates are not intended to be used for fracture compression.
The Resorb-X system is not intended for use in the mandible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, naso-ethomoidal, infraorbital, frontal sinus wall, midface
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.
K955729, K960988, K971870, K974309, K992158 - W. Lorenz Lactosorb® Trauma Plating System K972913 - Macropore Protective Sheet K974554 - Synthes Resorbable Fixation System K982139 - BioSorbFX, Bioabsorbable Fixation System K982531 - Howemedica Fixation System K993061 - Stryker Leibinger System
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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
R011590
MAR 2 0 2002
510(K) SUMMARY (as required by 807.92 9(c))
Submitter of 510(K):
Regulatory & Marketing Service, Inc. (RMS) 3234 Ella Lane New Port Ritchey, Florida 34655
813-645-2855 Phone: Fax: 813-645-2856
Contact Person:
Art Ward
Date of Summary:
Trade Name:
Classification Name:
Predicate Device:
Resorb-X Resorbable Plating System
Plate, Fixation, Bone, Non-Spinal, Non-Metallic
K955729, K960988, K971870, K974309, K992158 - W. Lorenz Lactosorb® Trauma Plating System K972913 - Macropore Protective Sheet K974554 - Synthes Resorbable Fixation System K982139 - BioSorbFX, Bioabsorbable Fixation System K982531 - Howemedica Fixation System K993061 - Stryker Leibinger System
Device Description/ Comparison:
The KLS-Martin Resorb-X resorbable plating system consists of all necessary Instrumentation to employ three diameters of screws with associated plates and meshes. The screws are Poly (D. L)-Lactid-Acid (PDLLA) and are available in diameters 1.6mm, 2.1mm and 2.4mm. The plates and meshes are the same material and vary in shape, size and thickness, and may be used with any of the above diameter screws to fixate.
The screws and plates are provided pre-sterilized by gamma irradiation and are not intended to be resterilized by the end user.
The screws are not intended to be used without a plate.
The screws require a pilot hole and this pilot hole must be tapped.
The plates are not intended to be used for fracture compression.
The Resorb-X system is not intended for use in the mandible.
1
The KLS-Martin Resorb-X System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton.
The KLS-Martin Resorb-X System is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply Imitations, insufficient quantity or quality of bone, or latent infections.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2002
KLS-Martin L. P. C/O Mr. Arthur Ward Regulatory and Marketing Services 962 Allegro Lane Apollo Beach, Florida 33572
Re: K011590
Trade/Device Name: Resorb-X Resorbable Plating System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 21, 2001 Received: December 26, 2001
Dear Mr. Ward:
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.
If your device is classified (see 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 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.
3
Page 2 - Mr. Ward
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _h(0|1590
Device Name:
Resorb-X Resorbable Plating System
Indications For Use:
The KLS-Martin Resorb-X System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton.
The KLS-Martin Resorb-X System is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 4 (Per 21 CFR 801-109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Roses
(Division Sign-Off) (Thesion of Dental, Infection Control, and General Hospital Dev 5 10(k) Number -----