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 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.

AI/ML Overview

The provided documentation describes the KLS Martin L.P. RxG Distraction System and outlines the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (LactoSorb Distraction System) through comparative mechanical testing. The implicit acceptance criterion is that the RxG Distraction System performs comparably to the predicate device in simulated use.

Characteristic / Test	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)	Reported Device Performance (RxG Distraction System vs. LactoSorb Distraction)
Mechanical Testing: Deformation measurements over simulated distraction and consolidation (52 days)	Performance comparable to the LactoSorb Distractor	"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	No claim of "pyrogen free" is made
Intended Use	Same intended use as the LactoSorb Distractor	"The RxG Distraction System has the same intended use as the predicate, the LactoSorb Distractor."
Technological Characteristics (Material, Sterility, Resorption Time, Max. Distraction Distance, Plate Thickness, Pin/Screw Diameter/Length etc.)	Similar to the LactoSorb Distractor (or other predicates for specific aspects)	Detailed comparison provided in the table, demonstrating similarities. For example, both use PLLA/PGA, have similar resorption times (12-14 months vs. 12 months), and comparable maximum distraction distances.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size (e.g., number of devices or iterations) for the comparative mechanical testing. It mentions "The devices were affixed to abutted sawbone blocks..." suggesting multiple instances, but no quantity is given.
Data Provenance: The study appears to be retrospective in the sense that it's a pre-market notification relying on comparison to already marketed devices. It is an in-vitro (benchtop) study using "sawbone blocks" rather than human or animal data. The country of origin for the data generation is not explicitly stated, but the submission is from a US company to the US FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of performance study for a medical device seeking 510(k) clearance. The "ground truth" for mechanical testing is established by physical measurement against engineering standards or direct comparison to a predicate device's measured performance, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable as there is no expert review or human interpretation of clinical data in this comparative mechanical test. The assessment is based on physical deformation measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study is focused on the mechanical performance of a device, not on the interpretative performance of human readers, with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is established through physical measurements of deformation under simulated conditions, directly compared to the measured performance of the predicate device. It is a benchtop (in-vitro) ground truth, not pathology, outcomes data, or expert consensus on clinical cases.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, and its development does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above (no training set for a physical device).

Summary

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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.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Jennifer DamatoDirector of Quality Mgt and Regulatory AffairsPhone: 800-625-1557Fax: 904-641-7378
Date Prepared:	May 13, 2014
Trade Name:	RxG Distraction System
Common Name:	Resorbable Distractor
Classification:	Bone PlateClass II, 21 CFR 872.4760, Product Code JEY
Predicate Devices:	LactoSorb Distraction (K030425, K002083)Resorb-X G (K112064), Zurich Distraction System (K010139)

Device Description:

Indications for Use:

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 Systemincludes devices intended for use inbone stabilization and elongation(lengthening) in the correction ofcongenital or developmental defectsof the midface and alveolar ridge.The RxG Distraction System alsoincludes devices intended for use inbone stabilization and elongation(lengthening) in the correction ofcongenital or developmental defectsof the mandible in patients 2 yearsold or younger.The RxG Distraction System is notintended for load-bearingapplications in adult or adolescentpopulations.	The Lorenz Resorbable Distraction Systemincludes devices intended for use in bonestabilization and elongation (lengthening)when correction of oral (alveolar ridge),cranial, maxillofacial deficiencies or post-traumatic defects require gradual bonedistraction. The Lorenz ResorbableDistraction System also includes devicesintended for use in bone stabilization andelongation (lengthening) when correctionof mandibular deficiencies or post-traumatic defects require gradual bonedistraction patients two (2) years old oryounger. The mid-face distractor isintended primarily for LeFort IIIosteotomies.	Resorb-X G is intended for use in non-load bearing fracture repair andreconstructive procedures inadolescent and adult populations. Inaddition, resorbable meshes, platesand pins may be used in non-loadingbearing applications for maintainingthe relative position of, and/orcontaining, bony fragments, bonegrafts (autograft or allograft), or bonegraft substitutes in oral andmaxillofacial reconstruction.	The Zurich Distraction Systemincludes devices intended as a bonestabilizer and lengthening (and ortransport) device when correction ofcongential deficiencies or posttraumatic defects of the mandible(including ramus, body, alveolar ridge,palate, symphisis), mid-face, andcranial bones require gradualdistraction.
Contraindications	1. Active infection2. Foreign body sensitivity	1. Active infection2. Foreign body sensitivity. Wherematerial sensitivity is suspected,testing is to be completed prior toimplantation.3. Patients with limited blood supply,insufficient quantity or quality ofbone, or latent infection.4. Patients, or parents/guardians ofpatients are unwilling or incapable offollowing postoperative careinstructions.5. Patients with bleeding disorders orpoor wound healing.6. Patients with metabolic disorders.	1. High-load regions in the absenceof traditional rigid fixation2. Active or latent infections3. Patients in a bad general state ofhealth or suffering frommetabolic disorders	1. Active infection2. Patient conditions including:blood supply limitations,insufficient quantity or quality ofbone or latent infections3. Patients with mental orneurologic conditions who areunwilling or incapable offollowing postoperative careinstructions4. Foreign body sensitivity - wherematerial sensitivity is suspected,tests are to be made prior toimplantation
Target Population	Pediatrics and Adults	Pediatrics and Adults	Adolescents and Adults	Pediatrics and Adults
Anatomical Sites	Oral, Mandibular and MaxillofacialAreas	Cranial, Oral, Mandibular andMaxillofacial Areas	Oral, Mandibular and MaxillofacialAreas	Cranial, Oral, Mandibular andMaxillofacial 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
BonePins/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

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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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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.

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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 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)

Regulation Number and Section

§ 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.