RXG DISTRACTION SYSTEM
Device Facts
| Record ID | K133304 |
|---|---|
| Device Name | RXG DISTRACTION SYSTEM |
| Applicant | KLS-Martin L.P. |
| Product Code | JEY · Dental |
| Decision Date | May 15, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4760 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
RxG Distraction System is an implantable device for distraction osteogenesis to lengthen maxillary and mandibular bones. System comprises resorbable 85:15 PLLA/PGA footplates, a TI-6AL-4V or stainless steel threaded drive screw, and an activation arm. Footplates are secured to bone via SonicPins RxG on either side of an osteotomy. Activation arm extends through soft tissue for external manual operation by clinician or patient. Turning the arm separates plates to achieve up to 30 mm of distraction. After bone consolidation, drive screw is detached and removed; plates and pins remain to resorb over 12-14 months. Used in hospital settings for reconstructive procedures. Benefits include gradual bone lengthening and stabilization without permanent hardware.
Clinical Evidence
Bench testing only. Comparative mechanical testing performed between RxG distractor and LactoSorb predicate. Devices affixed to sawbone blocks, submerged in Ringer's solution for 48 hours, and subjected to simulated distraction and consolidation over 52 days. Deformation measured at regular intervals; results confirmed substantial equivalence.
Technological Characteristics
Materials: 85:15 PLLA/PGA (plates/pins), TI-6AL-4V or stainless steel (drive screw/activation arm). Resorption time: 12-14 months. Sterilization: Gamma radiation. Form factor: Threaded drive screw with footplates. Mechanical principle: Distraction osteogenesis via manual activation. No software or electronic components.
Indications for Use
Indicated for bone stabilization and elongation in correction of congenital or developmental defects of midface and alveolar ridge in pediatric and adult populations, and mandible in patients 2 years or younger. Not for load-bearing applications in adult or adolescent populations.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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.<br>11201 Saint Johns Industrial Pkwy S<br>Jacksonville, FL 32246 |
|--------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato<br>Director of Quality Mgt and Regulatory Affairs<br>Phone: 800-625-1557<br>Fax: 904-641-7378 |
| Date Prepared: | May 13, 2014 |
| Trade Name: | RxG Distraction System |
| Common Name: | Resorbable Distractor |
| Classification: | Bone Plate<br>Class II, 21 CFR 872.4760, Product Code JEY |
| Predicate Devices: | LactoSorb Distraction (K030425, K002083)<br>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.
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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<br>includes devices intended for use in<br>bone stabilization and elongation<br>(lengthening) in the correction of<br>congenital or developmental defects<br>of the midface and alveolar ridge.<br><br>The RxG Distraction System also<br>includes devices intended for use in<br>bone stabilization and elongation<br>(lengthening) in the correction of<br>congenital or developmental defects<br>of the mandible in patients 2 years<br>old or younger.<br><br>The RxG Distraction System is not<br>intended for load-bearing<br>applications in adult or adolescent<br>populations. | The Lorenz Resorbable Distraction System<br>includes devices intended for use in bone<br>stabilization and elongation (lengthening)<br>when correction of oral (alveolar ridge),<br>cranial, maxillofacial deficiencies or post-<br>traumatic defects require gradual bone<br>distraction. The Lorenz Resorbable<br>Distraction System also includes devices<br>intended for use in bone stabilization and<br>elongation (lengthening) when correction<br>of mandibular deficiencies or post-<br>traumatic defects require gradual bone<br>distraction patients two (2) years old or<br>younger. The mid-face distractor is<br>intended primarily for LeFort III<br>osteotomies. | Resorb-X G is intended for use in non-<br>load bearing fracture repair and<br>reconstructive procedures in<br>adolescent and adult populations. In<br>addition, resorbable meshes, plates<br>and pins may be used in non-loading<br>bearing applications for maintaining<br>the relative position of, and/or<br>containing, bony fragments, bone<br>grafts (autograft or allograft), or bone<br>graft substitutes in oral and<br>maxillofacial reconstruction. | The Zurich Distraction System<br>includes devices intended as a bone<br>stabilizer and lengthening (and or<br>transport) device when correction of<br>congential deficiencies or post<br>traumatic defects of the mandible<br>(including ramus, body, alveolar ridge,<br>palate, symphisis), mid-face, and<br>cranial bones require gradual<br>distraction. |
| Contraindications | 1. Active infection<br>2. Foreign body sensitivity | 1. Active infection<br>2. Foreign body sensitivity. Where<br>material sensitivity is suspected,<br>testing is to be completed prior to<br>implantation.<br>3. Patients with limited blood supply,<br>insufficient quantity or quality of<br>bone, or latent infection.<br>4. Patients, or parents/guardians of<br>patients are unwilling or incapable of<br>following postoperative care<br>instructions.<br>5. Patients with bleeding disorders or<br>poor wound healing.<br>6. Patients with metabolic disorders. | 1. High-load regions in the absence<br>of traditional rigid fixation<br>2. Active or latent infections<br>3. Patients in a bad general state of<br>health or suffering from<br>metabolic disorders | 1. Active infection<br>2. Patient conditions including:<br>blood supply limitations,<br>insufficient quantity or quality of<br>bone or latent infections<br>3. Patients with mental or<br>neurologic conditions who are<br>unwilling or incapable of<br>following postoperative care<br>instructions<br>4. Foreign body sensitivity - where<br>material sensitivity is suspected,<br>tests are to be made prior to<br>implantation |
| Target Population | Pediatrics and Adults | Pediatrics and Adults | Adolescents and Adults | Pediatrics and Adults |
| Anatomical Sites | Oral, Mandibular and Maxillofacial<br>Areas | Cranial, Oral, Mandibular and<br>Maxillofacial Areas | Oral, Mandibular and Maxillofacial<br>Areas | Cranial, Oral, Mandibular and<br>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<br>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 |
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RxG Distraction System, K13330
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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
.
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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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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.
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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
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# Indications for Use
# SECTION 4
510(k) Number (if known):
K133304
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)
