The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.

Device Description

The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of cranial 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 40 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

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Performance Bench	The RxG distractor should exhibit less deformation than the LactoSorb distractor.	The RxG Distraction System exhibited less deformation and achieved greater distraction distance than the LactoSorb distractor. The results showed substantial equivalence to the primary predicate.
Biocompatibility	Biocompatibility requirements met as per FDA Blue Book Memorandum #G95-1.	The RxG Distraction System patient-contacting materials are previously cleared, have the same chemical composition, manufacturing processes, body contact, and sterilization methods as the reference device. The biocompatibility requirements have been met.
Sterility	Achieve a Sterility Assurance Level (SAL) of 10⁻⁶.	The subject device undergoes the same sterilization methods as the reference devices and achieved an SAL of 10⁻⁶.
Packaging & Shelf-Life	Packaging suitable for sterilization and capable of maintaining sterility for shelf life.	The packaging & shelf-life for the subject device is identical to a reference device. The packaging is suitable for the intended sterilization process and can maintain sterility during the intended shelf life period of 5 years.

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

The document only describes non-clinical testing.

Performance Bench: The test involved comparing the RxG distractor to the LactoSorb distractor. The sample size for this comparative mechanical testing is not specified in the provided text.
Data Provenance: The tests are described as non-clinical (bench testing), so there's no patient data or country of origin to report.

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

Not applicable. The tests are non-clinical (bench testing) and do not involve human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The tests are non-clinical (bench testing) and do not involve human adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical implant system, not an AI-powered diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a medical implant system, not an algorithm. No standalone performance study (in the context of AI) was done.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests was based on:

Performance Bench: Direct measurements of deformation and distraction distance during simulated osteotomy in a controlled laboratory setting.
Biocompatibility: Adherence to FDA-recognized international standards (ISO 10993).
Sterility: Adherence to international standards for sterilization validation (ISO 11137, ISO 11737).
Packaging & Shelf-Life: Adherence to international standards for packaging integrity (ISO 11607) and real-time stability testing.

8. The Sample Size for the Training Set

Not applicable. This device is a medical implant system, not an AI model that requires a training set.

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

Not applicable. This device is a medical implant system, not an AI model.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The KLS-Martin RxG Distraction System demonstrated substantial equivalence through a series of non-clinical laboratory tests. These tests compared the subject device to its primary predicate (LactoSorb Distraction, K002083) and referenced other cleared devices (RxG Distraction System, K133304; Resorb-X G, K121606) to demonstrate that the new device does not raise new issues of safety or effectiveness.

The key studies and their findings were:

Performance Bench Testing: Comparative mechanical testing was conducted between the RxG distractor and the LactoSorb distractor. The devices were affixed to sawbone blocks, simulating an osteotomy, and placed in a Ringer's solution waterbath. After a 48-hour latency period, distraction and consolidation were simulated over 52 days, with deformation measurements taken at regular intervals. The RxG Distraction System met the acceptance criterion by exhibiting less deformation and achieving greater distraction distance than the predicate device.
Biocompatibility Testing: The biocompatibility of the materials (Resorb xG, Ti-6Al-4V, and Stainless Steel) was assessed according to FDA Blue Book Memorandum #G95-1, encompassing toxicology, cytotoxicity, and chemical analysis. The materials in the subject device were deemed to have met biocompatibility requirements as they are identical to those previously cleared in reference devices, with the same chemical composition, manufacturing processes, body contact, and sterilization methods.
Sterility Testing: Validation of the gamma sterilization process was performed in accordance with ISO 11137-1, -2, and ISO 11737-1, -2. The tests included bioburden assessment and dose verification. The sterilization methods achieved an SAL of 10⁻⁶, meeting the acceptance criteria.
Packaging & Shelf-Life Testing: Validation of package integrity was conducted per ISO 11607-1, -2, and real-time stability testing was performed for the Resorb xG implants. The packaging and shelf-life were found to be identical to a reference device, confirming its suitability for sterilization and maintenance of sterility for a 5-year shelf life.

Clinical testing was explicitly stated as "not necessary for the determination of substantial equivalence." This indicates that the non-clinical data was considered sufficient by the FDA to demonstrate that the RxG Distraction System is as safe and effective as existing legally marketed devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 27, 2015

KLS-Martin L.P. Mr. Gary Moore Ouality MGT and Regulatory Affairs Manager 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K150771

Trade/Device Name: RxG Distraction System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: July 21, 2015 Received: July 24, 2015

Dear Mr. Moore:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. 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/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 Industry and Consumer Education 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,

Carlos L. Pena -SFD/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150771

Device Name RxG Distraction System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Registration Use (Part 21 CFR 201 Subpart D) OTC System Use (Part 21 CFR 201 Subpart G)
-------------------------------------------------	--------------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are smaller than the other letters.

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartinnorthamerica.com

	510(k) Summary21 CFR 807.92
Submitter:	KLS-MARTIN L.P.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Jennifer DamatoDirector of Quality MGT & Regulatory AffairsPhone: 800-625-1557Fax: 904-641-7378
Date Prepared:	August 19, 2015
Trade Name:	RxG Distraction System
Common Name:	Cranial Distraction System
Classification:	Preformed nonalterable cranioplasty plateClass II, 21 CFR 882.5330, Product Code PBJ
Primary Predicate:	LactoSorb Distraction (K002083)
Reference Devices:	RxG Distraction System (K133304)Resorb-X G (K121606)

Device Description:

The purpose of this Traditional 510(k) is to expand the indications for use of the RxG Distraction System to include cranial use in the pediatric and adult populations.

Indications for Use:

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KLS martın LP.

P.O. Box 16369 • Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartinnorthamerica.com

Technological Characteristics / Substantial Equivalence:

	RxG Distraction System(Subject Device)	LactoSorb Distraction(Primary Predicate – K002083)	RxG Distraction System(Reference Device – K133304)	Resorb-X G(Reference Device – K121606)
Indications for Use	The RxG Distraction System includesdevices intended for use in bonestabilization and elongation(lengthening) in the correction ofcongenital or developmental defects incranial reconstruction for the pediatricand adult populations.	The Lorenz Resorbable Distraction Systemincludes devices intended for use in bonestabilization and elongation (lengthening)when correction of oral (alveolar ridge),cranial, maxillofacial deficiencies orpost-traumatic defects require gradual bonedistraction. The Lorenz Resorbable DistractionSystem also includes devices intended for usein bone stabilization and elongation(lengthening) when correction of mandibulardeficiencies or post-traumatic defects requiregradual bone distraction patients two (2) yearsold or younger. The mid-face distractor isintended primarily for LeFort III osteotomies.	The RxG Distraction System includesdevices intended for use in bonestabilization and elongation(lengthening) in the correction ofcongenital or developmental defects ofthe midface and alveolar ridge.The RxG Distraction System alsoincludes devices intended for use inbone stabilization and elongation(lengthening) in the correction ofcongenital or developmental defects ofthe mandible in patients 2 years old oryounger.The RxG Distraction System is notintended for load-bearing applicationsin adult or adolescent populations.	Resorb-X G is intended for use innon-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 cranialreconstruction.
Contraindications	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 incapableof following postoperative careinstructions.5. Patients with bleeding disorders orpoor wound healing.6. Patients with metabolic disorders.	1. Active infection2. Foreign body sensitivity. Where materialsensitivity is suspected, testing is to becompleted prior to implantation.3. Patients with limited blood supply,insufficient quantity or quality of bone,or latent infection.4. Patients, or parents/guardians of patientsare unwilling or incapable of followingpostoperative care instructions.5. Patients with bleeding disorders or poorwound healing.6. Patients with metabolic disorders.	1. Active infection2. Foreign body sensitivity	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
Target Population	Pediatrics and Adults	Pediatrics and Adults	Pediatrics and Adults	Pediatrics and Adults
Anatomical Sites	Cranial	Cranial, Oral, Mandibular, and Maxillofacial	Oral, Mandibular, and Maxillofacial	Cranial
	RxG Distraction System(Subject Device)	LactoSorb Distraction(Primary Predicate – K002083)	RxG Distraction System(Reference Device- K133304)	Resorb-X G(Reference Device – K121606)
Materials
Bone Plates	85:15 PLLA-PGA	82:18 PLLA-PGA	85:15 PLLA-PGA	85:15 PLLA-PGA
BonePins/Screws	85:15 PLLA-PGA	82:18 PLLA-PGA	85:15 PLLA-PGA	85:15 PLLA-PGA
Drive Screw	TI-6AL-4V or Stainless Steel	Stainless Steel	TI-6AL-4V or Stainless Steel	N/A
Activation Arm	TI-6AL-4V or Stainless Steel	TI-6AL-4V , Stainless Steel	TI-6AL-4V or Stainless Steel	N/A
Sterility	Provided Sterile (GammaRadiation)	Provided Sterile (ETO)	Provided Sterile (GammaRadiation)	Provided Sterile (GammaRadiation)
Standards Met	See Section 9.0	ASTM F136, ASTM F138	Same as current submission	ISO 10993-1, -5, -12, -18ISO 11137-1, -2, 11737-1, -2
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	H2O and CO2
Resorption Time	12 - 14 months	12 months	12 - 14 months	12 - 14 months
Max. Distraction Distance
CranialDistractor	40 mm	40 mm	N/A	N/A
Alveolar RidgeDistractor	N/A	25 mm	25 mm	N/A
MidfaceDistractor	N/A	40 mm	30 mm	N/A
MandibularDistractor	N/A	25 mm	30 mm	N/A
Plate Thickness	2 - 5 mm	2 - 5 mm	2 - 5 mm	0.3 - 1.0 mm
Cumulative Max. PlateVolume	7840 mm3	Unknown	7840 mm3	15876 mm3
Pin/Screw Diameter	1.6 mm or 2.1 mm	1.5 – 2.5 mm	2.1 mm	1.6 mm or 2.1 mm
Pin/Screw Length	3 - 9 mm	6 - 9 mm	3 - 7 mm	3 - 7 mm

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kıs martın L.P.

P.O. Box 16369 • Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 ● Fax 904-641-7378 www.klsmartinnorthamerica.com

Technological Characteristics / Substantial Equivalence, Continued:

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Image /page/6/Picture/0 description: The image shows the logo for KLS Martin L.P. The text "KLS" is in red, while the text "martin" is in gray. The text "L.P." is in black and is smaller than the other text. The logo is simple and modern.

Nonclinical Testing:

Nonclinical testing to support substantial equivalence of the RxG Distraction System is summarized in the following table:

Test	Summary	Results
Performance Bench	Comparative mechanical testing was performed between the RxG distractor and LactoSorb distractor to measure deformation and distraction distance. Acceptance Criteria: The RxG distractor should exhibit less deformation than the LactoSorb distractor. Devices were affixed to sawbone blocks to simulate an osteotomy, and then placed in a waterbath of Ringer's solution for the duration of testing. After the 48 hour latency period, distraction and consolidation were simulated over a period of 52 days. Deformation measurements were taken at regular intervals.	Final deformation was determined by measuring the distance between the two footplates of each distractor. The RxG Distraction System exhibited less deformation and achieved greater distraction distance than the LactoSorb distractor.The results of the testing showed substantial equivalence to the primary predicate.
Biocompatibility	Biocompatibility requirements were assessed in accordance with FDA Blue Book Memorandum #G95-1 “Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by FDA. The battery of testing included the following tests:Toxicology Cytotoxicity Chemical Analysis	The RxG Distraction System patient-contacting materials Resorb xG, Ti-6Al-4V, and Stainless Steel used for the components in the subject device are previously cleared in K133304, have the same chemical composition, undergo the same manufacturing processes, have the same body contact, and are subjected to the same sterilization methods as the reference device.The results of the testing showed that the biocompatibility requirements have been met. No claim of "pyrogen free" is made.
Sterility	Bioburden, dose verification, and tests of sterility for the gamma sterilization process were validated in accordance with ISO 11137-1, -2, as well as ISO 11737-1, -2 to achieve an SAL of 10-6.	The subject device undergoes the same sterilization methods as the reference devices in K121606 and K133304.The results of the testing showed that the sterilization doses achieve an SAL of 10-6 for the devices.
Packaging & Shelf-Life	Validation of package integrity was performed in accordance with ISO 11607-1, -2. Real-time stability testing was performed for the Resorb xG implants in K121606.	The packaging & shelf-life for the subject device is identical to the reference device in K133304.The results of the testing showed that the packaging is suitable for the intended sterilization process and can maintain sterility during the intended shelf life period of 5 years.

Clinical Testing:

Clinical testing was not necessary for the determination of substantial equivalence.

Conclusions:

The RxG Distraction System has the same intended use as the primary predicate, the LactoSorb Distractor (K002083). In addition, the subject device has the same technological characteristics as the RxG Distraction System (K133304) and Resorb-X G (K121606) reference devices. The nonclinical testing results and similarities in technological characteristics do not raise new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate devices.

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).