(199 days)
Not Found
No
The device description and performance studies focus on mechanical components and their function in bone distraction, with no mention of AI or ML technologies.
Yes
The device is described as being used for "bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects" and involves "distraction osteogenesis," which are therapeutic medical procedures.
No
Explanation: The device is described as an implantable system used for bone stabilization and elongation (lengthening) through distraction osteogenesis, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical, implantable components (footplates, drive screw, activation arm, SonicPins) and their mechanical function in bone distraction. There is no mention of software as a component or primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for bone stabilization and elongation through a surgical procedure (distraction osteogenesis) to correct physical defects. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details implantable components (footplates, drive screw, activation arm) that are physically placed within the patient's body to achieve a mechanical outcome (bone lengthening).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the midface and alveolar ridge.
The RxG Distraction System also includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the mandible in patients 2 years old or younger.
The RxG Distraction System is not intended for load-bearing applications in adult or adolescent populations.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of maxillary and mandibular bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 30 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, Mandibular and Maxillofacial Areas
Indicated Patient Age Range
Pediatrics and Adults (specifically, for mandibular defects, patients 2 years old or younger; not intended for load-bearing applications in adult or adolescent populations).
Intended User / Care Setting
Health Care Facilities/ Hospitals
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)
Comparative mechanical testing was performed between the RxG distractor and the LactoSorb distractor. The devices were affixed to abutted sawbone blocks to simulate an osteotomy and placed in a waterbath of Ringers solution for 48 hrs. Distraction and consolidation were then simulated over a period of 52 days. Deformation measurements were taken at regular intervals. The results of the mechanical testing showed that the RxG Distractor is substantially equivalent to the predicate.
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.
LactoSorb Distraction (K030425, K002083), Resorb-X G (K112064), Zurich Distraction System (K010139)
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
Image /page/0/Picture/1 description: The image shows the text "KLS martin L.P.". The text is in a bold, sans-serif font. The letters "KLS" and "LP" are in black, while the word "martin" is in a textured gray color. The text is horizontally aligned.
P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 · Fax 904-641-7378 www.klsmartin.com
MAY 1 5 2014
510(k) Summary Section 21 CFR 807.92
| 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: | May 13, 2014 |
| Trade Name: | RxG Distraction System |
| Common Name: | Resorbable Distractor |
| Classification: | Bone Plate
Class II, 21 CFR 872.4760, Product Code JEY |
| Predicate Devices: | LactoSorb Distraction (K030425, K002083)
Resorb-X G (K112064), Zurich Distraction System (K010139) |
Device Description:
The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of maxillary and mandibular bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 30 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.
Indications for Use:
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the midface and alveolar ridge.
The RxG Distraction System also includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the mandible in patients 2 years old or younger.
The RxG Distraction System is not intended for load-bearing applications in adult or adolescent populations.
1
P.O. Box 16369 • Jacksonville, FL 32245-6369
904-641-7746 or 800-625-1557 • Fax 904-641-7378
www.klsmartin.com
kts martin L.P.
| Characteristic | RxG Distraction System | LactoSorb Distraction | Resorb-X G | Zurich Distraction System |
|---|---|---|---|---|
| Indications for Use | The RxG Distraction System | |||
| includes devices intended for use in | ||||
| bone stabilization and elongation | ||||
| (lengthening) in the correction of | ||||
| congenital or developmental defects | ||||
| of the midface and alveolar ridge. |
The RxG Distraction System also
includes devices intended for use in
bone stabilization and elongation
(lengthening) in the correction of
congenital or developmental defects
of the mandible in patients 2 years
old or younger.
The RxG Distraction System is not
intended for load-bearing
applications in adult or adolescent
populations. | The Lorenz Resorbable Distraction System
includes devices intended for use in bone
stabilization and elongation (lengthening)
when correction of oral (alveolar ridge),
cranial, maxillofacial deficiencies or post-
traumatic defects require gradual bone
distraction. The Lorenz Resorbable
Distraction System also includes devices
intended for use in bone stabilization and
elongation (lengthening) when correction
of mandibular deficiencies or post-
traumatic defects require gradual bone
distraction patients two (2) years old or
younger. The mid-face distractor is
intended primarily for LeFort III
osteotomies. | 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. | The Zurich Distraction System
includes devices intended as a bone
stabilizer and lengthening (and or
transport) device when correction of
congential deficiencies or post
traumatic defects of the mandible
(including ramus, body, alveolar ridge,
palate, symphisis), mid-face, and
cranial bones require gradual
distraction. |
| Contraindications | 1. Active infection
2. Foreign body sensitivity | 1. Active infection
2. Foreign body sensitivity. Where
material sensitivity is suspected,
testing is to be completed prior to
implantation.
3. Patients with limited blood supply,
insufficient quantity or quality of
bone, or latent infection.
4. Patients, or parents/guardians of
patients are unwilling or incapable of
following postoperative care
instructions.
5. Patients with bleeding disorders or
poor wound healing.
6. Patients with metabolic disorders. | 1. High-load regions in the absence
of traditional rigid fixation
2. Active or latent infections
3. Patients in a bad general state of
health or suffering from
metabolic disorders | 1. Active infection
2. Patient conditions including:
blood supply limitations,
insufficient quantity or quality of
bone or latent infections
3. Patients with mental or
neurologic conditions who are
unwilling or incapable of
following postoperative care
instructions
4. Foreign body sensitivity - where
material sensitivity is suspected,
tests are to be made prior to
implantation |
| Target Population | Pediatrics and Adults | Pediatrics and Adults | Adolescents and Adults | Pediatrics and Adults |
| Anatomical Sites | Oral, Mandibular and Maxillofacial
Areas | Cranial, Oral, Mandibular and
Maxillofacial Areas | Oral, Mandibular and Maxillofacial
Areas | Cranial, Oral, Mandibular and
Maxillofacial Areas |
| Characteristic | RxG Distraction System | LactoSorb Distraction | Resorb-X G | Zurich Distraction System |
| Materials | | | | |
| Bone Plates | 85:15 PLLA/PGA | 82:18 PLLA/PGA | 85:15 PLLA/PGA | TI-6AL-4V or CP Titanium |
| Bone
Pins/Screws | 85:15 PLLA/PGA | 82:18 PLLA/PGA | 85:15 PLLA/PGA | TI-6AL-4V |
| Drive Screw | TI-6AL-4V or Stainless Steel | Stainless Steel | N/A | TI-6AL-4V |
| Activation Arm | TI-6AL-4V or Stainless Steel | TI-6AL-4V, Stainless Steel | N/A | TI-6AL-4V |
| Sterility | Provided Sterile (Gamma Radiation) | Provided Sterile (ETO) | Provided Sterile (Gamma Radiation) | Provided Non-Sterile (Steam) |
| Where used (hospital, home, ambulance, etc) | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/Hospitals |
| Breakdown Products (Plates, Pins/Screws) | H₂O and CO₂ | H₂O and CO₂ | H₂O and CO₂ | Not applicable |
| Resorption Time | 12-14 months | 12 months | 12-14 months | Not applicable |
| Max. Distraction Distance | | | | |
| Alveolar Ridge Distractor | 25 mm | 25 mm | N/A | 15 mm |
| Midface Distractor | 30 mm | 40 mm | N/A | 30 mm |
| Mandibular Distractor | 30 mm | 25 mm | N/A | 30 mm |
| Plate Thickness | 2-5 mm | 2-5 mm | 0.6 - 1.0 mm | 0.6 mm |
| Cumulative Max. Plate Volume | 7840 mm³ | Unknown | 15876 mm³ | Not applicable |
| Pin/Screw Diameter | 2.1 mm | 1.5-2.5 mm | 1.6 mm | 1.5 mm |
| Pin/Screw Length | 3-7 mm | 6-9 mm | 5 mm | 3.5-6 mm |
.
RxG Distraction System, K13330
5-2
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KUS MONTEN L.P. P.O.Box 18389 v Jacksonille, FL 3224-6369
Kiloman Can L.P. P.O.Box 16389 v Jacksonille, FL 3245-6369
www.klsmarti.com L. P. www.klsmartin.com
RxG Distraction System, K133304
.
5-3
3
Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The text is in a bold, sans-serif font. The letters are black and have a textured appearance.
Performance Testing:
Comparative mechanical testing was performed between the RxG distractor and the LactoSorb distractor. The devices were affixed to abutted sawbone blocks to simulate an osteotomy and placed in a waterbath of Ringers solution for 48 hrs. Distraction and consolidation were then simulated over a period of 52 days. Deformation measurements were taken at regular intervals. The results of the mechanical testing showed that the RxG Distractor is substantially equivalent to the predicate.
Pyrogenicity:
No claim of "pyrogen free" is made.
Conclusion:
The RxG Distraction System has the same intended use as the predicate, the LactoSorb Distractor. The performance testing results and similarities in technological characteristics do not raise new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate devices.
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Image /page/4/Picture/1 description: The image shows a circular seal with an emblem in the center. The emblem features a stylized bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle, following its curvature.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2014
KLS-Martin, LP Jennifer Damato Director of Quality Management and Regulatory Affairs 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 US
Re: K133304
Trade/Device Name: RxG Distraction System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: April 14, 2014 Received: April 17, 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.
5
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 of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21 CFR 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/Reportal?roblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary S: Runner -S
Erin I. Keith. M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
SECTION 4
510(k) Number (if known):
RxG Distraction System Device Name:
Indications for Use:
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the midface and alveolar ridge.
The RxG Distraction System also includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the mandible in patients 2 years old or younger.
The RxG Distraction System is not intended for load-bearing applications in adult or adolescent populations.
イ 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)
Sheena A Green S
2014.05.15 08.37.50 -04'00'
RxG Distraction System 510(k)