(116 days)
No
The description focuses on the material properties and mechanical function of the device (ultrasonic force for pin implantation) and does not mention any computational or data-driven capabilities indicative of AI/ML.
No.
The device is used for fracture repair and reconstructive procedures, which are not considered therapeutic interventions in the context of treating disease or illness.
No
The device is described as an implantable system (pins, meshes, plates) for fracture repair and reconstructive procedures, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical pins made of PDLLA and an ultrasonic unit, which are hardware components.
Based on the provided information, the KLS Martin SonicWeld RX (Resorb-X) 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the SonicWeld RX is a system of resorbable pins, plates, and meshes used for fracture repair and reconstructive procedures of the craniofacial skeleton. It is implanted directly into the body to fix bone fragments.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples from the body or perform any kind of diagnostic test.
The KLS Martin SonicWeld RX is a surgical implant used for internal fixation of bone.
N/A
Intended Use / Indications for Use
The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws 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 reconstruction of the craniofacial or mandibular areas. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) 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.
Product codes
JEY
Device Description
The SonicWeld RX (Resorb-X) is identical to RESORB-X® SF (K051236) which consists of RESORB-X® Pins made of Poly (D, L) -Lactide-Acid (PDLLA) of various diameters and lengths that are 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. The RESORB-X® SF pins are designed to be used in conjunction with RESORB-X® Resorbable Plating System plates (K011590).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, craniofacial or mandibular areas. The device is not intended for use in the spine.
Indicated Patient Age Range
pediatric 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Resorb-X Resorbable Plating System (K011590), Resorb-X SF (K051236), Synthes (USA) Rapid Resorbable Fixation System (K062789)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KO80862
:
kıs martın LP.
:
JUL 2 1 2008
510(K) SUMMARY
| Submitter: | KLS-Martin, L.P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Tom Faucett
RA/QA Supervisor | | |
| Date of Summary: | 18 March 2008 | | |
| Device Name: | SonicWeld RX (Resorb-X) | | |
| Trade Name: | SonicWeld RX (Resorb-X) | | |
| Common Name: | Bone Plate | | |
| Classification
Name and Number: | Bone Plate (872.4760) | | |
| Regulatory Class: | II | | |
| Predicate Devices: | Resorb-X Resorbable Plating System
(K011590)
Resorb-X SF (K051236)
Synthes (USA) Rapid Resorbable Fixation
System (K062789) | | |
| Intended Use: | The KLS Martin SonicWeld RX (Resorb-X) is
intended for use in fracture repair and
reconstructive procedures of the craniofacial
skeleton in pediatric and adult populations. In
addition, resorbable meshes, plates, screws
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 reconstruction of the
craniofacial or mandibular areas. | | |
1
The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) 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.
The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.
The SonicWeld RX (Resorb-X) is identical to RESORB-X® SF (K051236) which consists of RESORB-X® Pins made of Poly (D, L) -Lactide-Acid (PDLLA) of various diameters and lengths that are 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. The RESORB-X® SF pins are designed to be used in conjunction with RESORB-X® Resorbable Plating System plates (K011590).
Technological Characteristics:
Similarities to Predicate
The SonicWeld RX (Resorb-X) is identical to RESORB-X Resorbable Plating System (K011590) Resorb-X SF (K051236) in chemical composition.
The SonicWeld RX (Resorb-X) are the identical pins, screws and plates as the RESORB-X Resorbable Plating System (K011590) and Resorb-X SF (K051236) and are implanted in the identical manner.
Device Description:
2
Differences to Predicate
This submission expands the indications for use to include use in non-load bearing applications in the mandible.
Substantial Equivalence:
The SonicWeld RX (Resorb-X)is substantially equivalent in intended use to the RESORB-X Resorbable Plating System (K011590), Resorb-X SF (K051236) and the Synthes (USA) Rapid Resorbable Fixation System (K062789)
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Faucett Senior Regulatory Affairs/ Quality Assurance Specialist KLS Martin L.P. 11239 St. Johns Industrial Parkway South Jacksonville Florida 32246
JUL 2 1 2008
Re: K080862
Trade/Device Name: SonicWeld RX (Resorb-X) Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 17, 2008 Received: June 18, 2008
Dear Mr. Faucett:
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.
4
Page 2 - Mr. Faucett
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); 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 chassification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runore
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K080862 510(k) Number (if known):
SonicWeld RX (Resorb-X) Device Name:
Indications For Use: The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws 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 reconstruction of the craniofacial or mandibular areas. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) 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.
The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.
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 TF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Sue Kummer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090562
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