The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.

Cranium

. The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.

Device Description

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, and infants. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs as detailed in the table below.

AI/ML Overview

Acceptance Criteria and Study for Craniomaxillofacial Distraction System (CMFD)

The provided document describes the Craniomaxillofacial Distraction System (CMFD) and its demonstration of substantial equivalence to predicate devices. The "acceptance criteria" here refers to the performance benchmarks demonstrated through non-clinical testing to ensure the device is safe and effective and comparable to existing devices, especially given some technological differences.

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Implicit from Test Method/Predicate Comparison)	Reported Device Performance
Reversing Prevention	The device should not reverse unintentionally under conditions where the previous design of CMFD reversed.	The subject device does not reverse unintentionally under the same conditions where the previous design of CMFD reversed.
Construct Bending Strength	The CMFD construct should be at least as strong as the predicate KLS Arnaud distractor, and design changes should not weaken it.	The CMFD construct is stronger than the predicate KLS Arnaud distractor, and the design changes relative to the previous design in K060138 do not affect the strength of the distractor construct.
Torque Input/Force Output and Construct Torsional Strength	The device must be capable of outputting the force required to distract bone in the cranium without failing.	The device is capable of outputting the force required to distract bone in the cranium without failing.
Extension Arm Interface Tensile Strength	The interface between the distractor and extension arm must withstand a tensile force based on a human factors benchmark applicable to the previous CMFD design.	The redesigned CMFD meets the same human factors benchmark as the previous design of CMFD.
Biocompatibility	Materials should be biocompatible, either by using previously cleared materials or demonstrating biocompatibility for new materials.	For modified distractor bodies (new material, Cobalt Chromium), a risk-based assessment per ISO 10993-1 was conducted with supporting biocompatibility testing. Results demonstrated that the material change does not raise new questions of safety or efficacy with respect to biocompatibility. Other components use materials cleared in predicate K060138.
Steam Sterilization Validation	Must achieve a Sterility Assurance Level (SAL) of 10^-6 via steam sterilization using previously validated parameters.	The devices may be effectively steam sterilized by the proposed parameters, which are the same parameters as the previous design of CMFD. The sterilization parameters were validated using the "overkill" method as referenced in Annex D of ANSI/AAMI/ISO 17665-1 to assure an SAL of 10^-6.
Endotoxin Testing	Maximum endotoxin levels for finished devices must be met (e.g., 2.15 EU/device).	The subject devices meet the maximum endotoxin testing limit of 2.15 EU/device (quantified using a Kinetic Turbidimetric method).

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

The document does not specify sample sizes for the individual non-clinical tests (e.g., how many constructs were tested for bending strength, how many devices for reversing prevention). The tests are described generally, without providing specific numbers of units or repetitions.

The provenance of the data for these non-clinical tests would be the device manufacturer's (DePuy Synthes) internal testing laboratories or contracted labs, likely in the US (where the company is based). These are prospective tests performed specifically to support this regulatory submission.

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

This section is not applicable to the type of study presented. The studies described are non-clinical (mechanical, materials, sterilization, endotoxin) which rely on objective measurements and engineering standards, not expert interpretation of results to establish ground truth in the way a clinical study with image interpretation would.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments, where disagreements among experts need a resolution process. The tests performed here are objective engineering and laboratory tests.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicate devices, along with a literature review of the previous device. There is no mention of human readers or AI assistance.

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

This is not applicable as the device is a mechanical surgical implant (Craniomaxillofacial Distraction System), not an algorithm or AI software, so there is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is established by:

Engineering Standards and Specifications: For mechanical tests like bending strength, torsional strength, and tensile strength, the ground truth is defined by established engineering principles, material properties, and predetermined performance thresholds derived from predicate devices or clinical requirements.
Biocompatibility Standards: ISO 10993-1 provides the framework for biocompatibility assessment.
Sterilization Standards: ANSI/AAMI/ISO 17665-1 defines the "overkill" method for sterilization validation, setting the SAL of 10^-6 as the ground truth for sterility.
Endotoxin Limits: Established limits (e.g., 2.15 EU/device) are the ground truth for endotoxin testing.
Predicate Device Performance: Performance of the predicate devices implicitly sets a benchmark for acceptable "ground truth" performance for comparison.

8. The Sample Size for the Training Set

This section is not applicable. This is a submission for a mechanical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" in the context of device development or testing mentioned here.

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

This section is not applicable for the same reasons as #8.

Summary

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December 7, 2017

Synthes USA Products, LLC Nicholas Fountoulakis Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K170818

Trade/Device Name: Craniomaxillofacial Distraction System (CMFD) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Non-alterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: November 8, 2017 Received: November 9, 2017

Dear Mr. Fountoulakis:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carlos L. Pena -S

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) K170818

Device Name

Craniomaxillofacial Distraction System (CMFD)

Indications for Use (Describe)

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.

Cranium

The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, and adults.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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1. 510(k) Summary

Date Prepared: November 7, 2017

1.1.Submitter

Primary Contact: Nicholas Fountoulakis Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-6553 nfounto@its.jnj.com

Alternate Contact:

Susan Lewandowski Associate Director, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5852 slewand2@its.jnj.com

1.2.Device

Name of Device: Craniomaxillofacial Distraction System (CMFD) Common or Usual Name(s): Cranial Distraction System Classification Name(s): Preformed nonalterable cranioplasty plate Regulatory Class: Class II - 882.5330 Product Code: PBJ Review Panel: Neurology

1.3.Predicate Devices

Primary Predicate: Zurich Distraction System's Arnaud Distractor (K010139) Additional Predicate: Synthes Craniomaxillofacial Distraction System (K060138)

1.4.Indications for Use

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.

Cranium

. The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.

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1.5.Device Description

	Distractor Body	Footplates	Extension Arms	Bone Screws
Dimensions	10, 15, 20, 25,30, 35, and 40mm lengths	Cloverleaf andmesh designsAccept 1.5, 2.0,and 2.4 mmdiameter screws	Rigid lengths are20, 40, and 60mmFlexible lengthsare 30, 40, and60 mm	1.5, 2.0, and 2.4mm diameter4 – 12 mmlengths
Materials	TAN (ASTM F1295) L605 (ASTM F90) CoCrMo (ASTM F1537) MP35N (ASTM F562)	CP2 and CP4 Titanium (ASTM F67)	TAN (ASTM F1295) L605 (ASTM F90) MP35N (ASTM F562) Silicone (ASTM F2042)	CP Titanium (ASTM F67) TAN (ASTM F1295)

The distractor body is first secured to bone using footplates and screws, and then activation of the distractor is accomplished through the rotation of an advancement/lead screw with an activation instrument percutaneously.

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1.6.Comparison to Predicate Devices

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1.6.1. Summary Comparison of Intended Use

Both the subject DePuy Synthes CMFD System and the KLS Zurich Distraction System's Arnaud Distractor (K010139) are indicated for correction of congenital deficiencies or post-traumatic defects of the cranium where gradual bone distraction is required. Additionally, clinical literature is provided in this submission discussing the effective use of the previous design of Synthes CMF Distraction System (K060138) in cranial distraction osteogenesis. The proposed use of the subject CMFD in the cranium does not constitute a new intended use not already addressed by the predicate device.

1.6.2. Summary Comparison of Technological Characteristics

The major technological differences between the subject CMFD in comparison to predicate KLS Zurich Distraction System's Arnaud Distractor (K010139) are:

The subject device features a reversing prevention mechanism while the predicate does ● not. Non-clinical performance data of the reversing prevention mechanism demonstrates its efficacy.
. The subject device is made of commercially pure titanium alloy (TAN), cobalt chromium alloys (L605, MP25N, and CoCrMo), and silicone while the predicate is made of titanium and titanium alloy (TAV). However, these materials were used in other implantable components of the previous design of CMFD and are materials with established biocompatibility.

1.7.Non-clinical performance data

Non-clinical performance data demonstrates that the technological differences of the CMFD System do not raise new questions of safety and efficacy with respect to the predicate devices, and therefore support substantial equivalence:

Test Name	Test Method Summary	Results
Reversing Prevention	Anatomically simulatedspinning and vibration of thesubject distractor and theprevious design of CMFD.	The subject device does notreverse unintentionally underthe same conditions wherethe previous design of CMFDreversed.
Construct bending strength	Four-point bend test setup ofa subject device construct incomparison to the predicateKLS Zurich DistractionSystem's Arnaud Distractor,and analysis comparing thesubject design to theprevious design of CMFD.	The CMFD construct isstronger than the predicateKLS Arnaud distractor, andthe design changes relativeto the previous design inK060138 do not affect thestrength of the distractorconstruct.
Torque Input/Force Outputand Construct TorsionalStrength	This testing challenged theconstruct in torsion byapplying an increasing torque(torque input) to theactivation end of the devicethrough an extension armuntil failure of the deviceoccurred.	The device is capable ofoutputting the force requiredto distract bone in thecranium without failing.
Extension arm interfacetensile strength	This testing challenged theinterface between thedistractor and extension armto ensure the interface canwithstand a tensile forcebased on a human factorsbenchmark.	The redesigned CMFD meetsthe same human factorsbenchmark as the previousdesign of CMFD.
Biocompatibility	All subject devices with theexception of the modifieddistractor bodies utilize thesame materials andmanufacturing processes asthe predicate devices clearedin K060138, and thereforebiocompatibility testing wasnot provided.For the modified distractorbodies, a risk basedassessment per ISO 10993-1was conducted, andsupporting biocompatibilitytesting was provided.	The results ofbiocompatibility riskassessment and testingdemonstrate that thematerial change to thedistractor body does notraise new questions of safetyor efficacy with respect tobiocompatibility.
Steam Sterilization Validation	The sterilization parameterswere validated using the"overkill" method asreferenced in Annex D ofANSI/AAMI/ISO 17665-1 inorder to assure a SterilityAssurance Level (SAL) of 10-6.	The devices may beeffectively steam sterilized bythe proposed parameters,which are the sameparameters as the previousdesign of CMFD.
Endotoxin Testing	Endotoxin levels for finishedsubject devices werequantified using a KineticTurbidimetric method.	The subject devices meet themaximum endotoxin testinglimit of 2.15 EU/device.

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1.8.Clinical performance data

Clinical literature discussing the application of the previous design of CMFD (K060138) in the cranium is provided in this submission. A literature review was conducted and seven articles were identified discussing the use of the previous design of CMFD (K060138) in the cranium. The previous design of CMFD (K060138) was identified through narrative descriptions, x-rays, and/or images within the articles.

1.9.Substantial Equivalence

Results of non-clinical performance testing, discussions of clinical literature, and comparison to predicate devices included in this submission demonstrate that:

Technological differences of the CMFD System in comparison to the predicate devices does not raise new questions of safety and efficacy
The proposed CMFD System has the same intended use as the predicate devices

It is concluded that the information provided in this submission supports substantial equivalence.

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).

System/Device Name	Synthes CraniomaxillofacialDistraction System	KLS Zurich Distraction System'sArnaud Distractor	Synthes CraniomaxillofacialDistraction System (previousdesign)
Indications	The DePuy Synthes CMFDistraction System is intended foruse as a bone stabilizer andlengthening (and/or transport)device.The DePuy Synthes CMFDistraction System is indicated forcorrection of congenitaldeficiencies or post-traumaticdefects of the cranium, wheregradual bone distraction isrequired in adults and pediatricpatients. DePuy Synthes CMFDistraction System is intended forsingle use only.CraniumThe 1.5 mm and 2.0 mmmesh and cloverleaffootplates and screws areintended for infants,children, adolescents, andadults.	The Zurich Distraction Systemincludes devices intended as abone stabilizer and lengthening(and/or transport) device whencorrection of congenitaldeficiencies or post traumaticdefects of the mandible (includingramus, body, alveolar ridge, palate,symphysis), midface, and cranialbones require gradual distraction.	The Synthes CraniomaxillofacialDistraction System (CMFDistraction System) is intended foruse as a bone stabilizer andlengthening (and/or transport)device for correction of congenitaldeficiencies or post-traumaticdefects of the mandibular bodyand ramus where gradual bonedistraction is required.The Synthes CMF DistractionSystem is intended for single useonly. The Synthes Pediatric CMFDistraction System is intended foruse as a bone stabilizer andlengthening (and/or transport)device for correction of congenitaldeficiencies or post-traumaticdefects of the mandibular bodyand ramus where gradual bonedistraction is required in childrenunder the age of 12 months. TheSynthes Pediatric CMF DistractionSystem is intended for single useonly.
Contraindications	The Synthes CMF DistractionSystem is contraindicated for		Use of the Synthes CMF DistractionSystem is contraindicated in
System/Device Name	Synthes CraniomaxillofacialDistraction System	KLS Zurich Distraction System'sArnaud Distractor	Synthes CraniomaxillofacialDistraction System (previousdesign)
	patients sensitized to nickel, cobaltchromium, silicone ormolybdenum.		patients previously sensitized tonickel
Where Used	Hospital, home	Hospital, home	Hospital, home
System Features	Modular design includes body,plates, and removable activationarms	Pre-assembled distractor body andplates with removable and non-removable activation arm	Modular design includes body,plates, and removable activationarms
	Surgeon and Patient FacingInstrumentation	Surgeon and Patient FacingInstrumentation	Surgeon and Patient FacingInstrumentation
Distractor BodySpecifications	End and center translating 10 - 40 mm lengths	End and center translating 20 mm and 30 mm lengths	End and center translating 10 - 40 mm lengths
	Accommodates left and rightplacement Available with or withoutuniversal joint Spring clip to preventinadvertent reversing	Accommodates left and rightplacement Available with or withoutuniversal joint (2.0 mm size)	Accommodates left and rightplacement Available with or withoutuniversal joint
Plate Specifications	Cloverleaf and mesh designs Symmetric design May be cut and bent Fixed with 1.5, and 2.0 mm	Mesh design Symmetric design May be cut and bent Fixed with 1.5, and 2.0 mm	Cloverleaf, mesh, and elevatedmesh designs Symmetric design May be cut and bent Fixed with 1.0, 1.3, 1.5, and 2.0 mm
System/Device Name	Synthes CraniomaxillofacialDistraction System	KLS Zurich Distraction System'sArnaud Distractor	Synthes CraniomaxillofacialDistraction System (previousdesign)
	Fixed with 2.0 and 2.4 mm Emergency Screws Fixed with 2.0 mm Locking Screws	Fixed with 1.8, and 2.3 mm Emergency Screws	Fixed with 1.2, 1.7, 2.0, 2.4 mm PlusDrive Emergency Screws Fixed with 2.0 mm Locking Screws
Extension ArmSpecifications	Point of activation moved away from distractor for patient access Rigid and flexible options May be removed without surgical procedure Rigid lengths are 20, 40, and 60 mm Flexible lengths are 30, 40, and 60 mm May be combined to increase length	Point of activation moved away from distractor for patient access Rigid and flexible options (2.0 mm size) May be removed without surgical procedure (2.0 mm size) Rigid lengths are 25, 33, 35, 43, 45, 50, and 53 mm Flexible lengths are 30, 33, 40, and 50 mm (2.0 mm size) May be combined to increase length (2.0 mm size)	Point of activation moved away from distractor for patient access Rigid and flexible options May be removed without surgical procedure Rigid lengths are 20, 40, and 60 mm Flexible lengths are 30, 40, and 60 mm May be combined to increase length
Operating Principle(s)	Advancement/lead screwadjustment of metallic plate andscrew construct to achievedistraction osteogenesis	Advancement/lead screwadjustment of metallic plate andscrew construct to achievedistraction osteogenesis	Advancement/lead screwadjustment of metallic plate andscrew construct to achievedistraction osteogenesis
Materials	Distractor Bodies:Titanium Alloy TAN (ASTM F1295) Chromium Cobalt L605 (ASTM F90) CoCrMo (ASTM F1537) MP35N (ASTM F562)	Distractor Body:Titanium Alloy TAV (ASTM F136)	Distractor Bodies:Titanium Alloy TAN (ASTM F1295) Chromium Cobalt L605 (ASTM F90)
System/Device Name	Synthes CraniomaxillofacialDistraction System	KLS Zurich Distraction System'sArnaud Distractor	Synthes CraniomaxillofacialDistraction System (previousdesign)
	Plates:CP2 or CP4 Titanium (ASTM F67)Extension Arms:Titanium Alloy• TAN (ASTM F1295)Chromium Cobalt• L605 (ASTM F90)• MP35N (ASTM F562)Silicone (ASTM F2042)	Plates:CP Titanium (ASTM F67)Extension Arms:Titanium Alloy• TAV (ASTM F136)	Plates:CP2 or CP4 Titanium (ASTM F67)Extension Arms:Titanium Alloy• TAN (ASTM F1295)Chromium Cobalt• L605 (ASTM F90)• MP35N (ASTM F562)Silicone (ASTM F2042)
	Screws:• TAN (ASTM F1295)	Screws:• CP Titanium (ASTM F67)	Screws:• CP Titanium (ASTM F67)• TAN (ASTM F1295)
Sterility	NonsterileSterilized to SAL of 10-6 via steam(moist-heat) prior to use	NonsterileSterilized via steam (moist-heat)prior to use	NonsterileSterilized to SAL of 10-6 via steam(moist-heat) prior to use