(248 days)
Not Found
No
The summary describes a resorbable fixation system utilizing ultrasonic technology for implantation, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
Explanation: A therapeutic device is designed to treat or alleviate a disease or condition. This device is a resorbable fixation system for fracture repair and reconstructive procedures, which is a supportive and restorative function rather than a direct therapeutic intervention.
No
The device is a resorbable fixation system for fracture repair and reconstructive procedures, not a device used to identify the presence or absence of a disease or condition.
No
The device description clearly states it consists of physical components (plates, meshes, and pins) and is implanted using an ultrasonic unit, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for surgical fixation of fractures and reconstructive procedures. This is a direct intervention on the body.
- Device Description: The device description details plates, meshes, and pins used for mechanical stabilization of bone.
- 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 for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
The KLS Martin Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in adolescent and adult populations. In addition, resorbable meshes, plates and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in oral and maxillofacial reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
KLS Martin Resorb-X G is a resorbable fixation system similar to the SonicWeld-RX (Resorb-X) (K080862). The system consists of plates, meshes and pins manufactured in a variety of diameters and geometrical configurations that provide fixation and aid in the alignment and stabilization of fractures and reconstructive procedures. Resorb-X G is implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adolescent and adult populations.
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)
Performance Testing: Chemical analysis to ISO 10993-12, -18 and mechanical degradation comparison testing for PDLLA vs. PLLA/PGA were submitted to demonstrate product safety and effectiveness.
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.
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
MAR 2 3 2012
510(K) SUMMARY
Section 21CFR 807.92(a)
Section 21CFR 807.92(a)
| Submitter: | KLS-Martin, L.P.
11201 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
RA/QA Director |
| Date of Summary: | October 28, 2011 |
| Device Name: | KLS Martin Resorb-X G |
| Trade Name: | Resorb-X G |
| Classification: | Class II, §872.4760- Bone Plate |
| Product Code: | JEY |
| Predicate Devices: | SonicWeld RX (Resorb-X) (K080862)
Synthes (USA) Rapid Resorbable Fixation System (K062789)
Biomet, Inc. Lactosorb Trauma Plating System (K992355) |
| Device Description: | KLS Martin Resorb-X G is a resorbable fixation system
similar to the SonicWeld-RX (Resorb-X) (K080862). The
system consists of plates, meshes and pins manufactured in a
variety of diameters and geometrical configurations that
provide fixation and aid in the alignment and stabilization of
fractures and reconstructive procedures. Resorb-X G is
implanted utilizing ultrasonic force generated by an ultrasonic
unit that causes a phase transition in the pin, allowing the pin
to adapt to the previously drilled pilot hole in the surgical site
and utilize the micro undercuts of the bone for retention. |
| Intended Use: | The KLS Martin Resorb-X G is intended for use in non-load
bearing fracture repair and reconstructive procedures in
adolescent and adult populations. In addition, resorbable
meshes, plates and pins may be used in non-loading bearing
applications for maintaining the relative position of, and/or
containing, bony fragments, bone grafts (autograft or
allograft), or bone graft substitutes in oral and maxillofacial
reconstruction. |
1
Contraindications:
These devices are not intended for use in load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. Resorb-X G is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.
Technological Characteristics:
Similarities to Predicate
Resorb-X G uses the same pins, screws, and plates as SonicWeld-RX (Resorb-X) and is implanted in the same manner. The indication for use is the same as SonicWeld-RX (Resorb-X) K080862.
Differences to Predicate
Resorb-X G (PLLA/PGA) material differs in chemical composition from the SonicWeld-RX (Resorb-X) (PDLLA) material, but is the same as that in K062789 and K992355.
Performance Testing: Chemical analysis to ISO 10993-12, -18 and mechanical degradation comparison testing for PDLLA vs. PLLA/PGA were submitted to demonstrate product safety and effectiveness.
Substantial Equivalence: Performance testing results demonstrate that Resorb-X G (PLLA/PGA) is substantially equivalent to Resorb-X (PDLLA) and does not raise new issues of safety or effectiveness.
Material: Poly(L-lactide-co-glycolide) (PLLA/PGA)
2
Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jennifer Damato Director of Quality Management & Regulatory Affairs KLS-Matrin L.P. 11201 Saint Johns Industrial Parkway South P.O. Box 16369 Jacksonville, Florida 32245-6369
MAR 2 3 2012
Re: K112064
Trade/Device Name: Resorb-X G Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 12, 2012 Received: March 13, 2012
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.
3
Page 2 - Ms. Damato
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
112064
SECTION 4
Indications for Use
SECTION 4
510(k) Number (if known): _
Device Name: _
Resorb-X G
Indications for Use:
The KLS Martin Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in adolescent and adult populations. In addition, resorbable meshes, plates and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in oral and maxillofacial reconstruction.
Prescription Use イ (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)
Susan Penner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K112064
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