K Number
K162594
Device Name
Craniomaxillofacial Distraction System (CMFD)
Date Cleared
2017-05-08

(234 days)

Product Code
Regulation Number
872.4760
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only. Mandible - The 1.0 mm plates and screws are intended for neonates and infants under the age of 12 months - The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger - The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older
Device Description
DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the mandibular body and mandibular ramus in adults, adolescents, children, infants, and neonates. The distractor implant consists of several components; the distractor body, footplates, extension arms, and bone screws, many of which are available in a variety of configurations to meet patient and surgeon needs as detailed the table below. | Component | Distractor Body | Footplates | Extension Arms | Bone Screws | |------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Dimensions | 10, 15, 20, 25, 30,<br>35, and 40 mm<br>lengths | Cloverleaf, mesh,<br>and elevated mesh<br>designs<br>Accept 1.0, 1.2, 1.3,<br>1.5, 1.7, 2.0, and 2.4<br>mm diameter<br>screws | Rigid lengths are 20,<br>40, and 60 mm<br>Flexible lengths are<br>30, 40, and 60 mm | 1.0, 1.2, 1.3, 1.5, 1.7,<br>2.0, and 2.4 mm<br>diameter<br>4 – 12 mm lengths | | Materials | ● TAN (ASTM<br>F1295)<br>● L605 (ASTM<br>F90)<br>● CoCrMo (ASTM<br>F1537)<br>● MP35N (ASTM<br>F562) | ● CP2 and CP4<br>Titanium (ASTM<br>F67) | ● TAN (ASTM<br>F1295)<br>● L605 (ASTM<br>F90)<br>● MP35N (ASTM<br>F562)<br>● Silicone (ASTM<br>F2042) | ● CP Titanium<br>(ASTM F67)<br>● TAN (ASTM<br>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 either percutaneously or intra-orally.
More Information

Synthes Curvilinear Distraction System (K121502)

No
The device description and performance studies focus on mechanical properties and biocompatibility of a physical implant for bone distraction. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Yes
The device is described as a "bone stabilizer and lengthening (and/or transport) device" intended for "correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required." This directly aligns with the definition of a therapeutic device, as it is used to treat or alleviate a medical condition.

No

Explanation: The device is intended for use as a bone stabilizer and lengthening device to correct congenital deficiencies or post-traumatic defects, not to diagnose medical conditions.

No

The device description explicitly details physical hardware components made of various materials (TAN, L605, CoCrMo, MP35N, CP2 and CP4 Titanium, Silicone) including plates, screws, distractor bodies, footplates, and extension arms. It also describes the mechanical function of the device (rotation of an advancement/lead screw). This is clearly a hardware medical device.

Based on the provided information, the DePuy Synthes CMF Distraction System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is described as a "bone stabilizer and lengthening (and/or transport) device" for correcting congenital deficiencies or post-traumatic defects of the mandibular body and ramus. This is a surgical implant used directly on the patient's body.
  • Device Description: The device is a modular distractor system consisting of physical components (distractor body, footplates, extension arms, bone screws) made of various materials. It is surgically implanted and activated mechanically.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.

Therefore, the DePuy Synthes CMF Distraction System is a surgical implant, not an IVD.

N/A

Intended Use / Indications for Use

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

The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only.

Mandible
• The 1.0 mm plates and screws are intended for neonates and infants under the age of 12 months
• The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger
• The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older

Product codes (comma separated list FDA assigned to the subject device)

MQN

Device Description

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the mandibular body and mandibular ramus in adults, adolescents, children, infants, and neonates. The distractor implant consists of several components; the distractor body, footplates, extension arms, and bone screws, many of which are available in a variety of configurations to meet patient and surgeon needs as detailed the table below.

ComponentDimensionsMaterials
Distractor Body10, 15, 20, 25, 30, 35, and 40 mm lengthsTAN (ASTM F1295), L605 (ASTM F90), CoCrMo (ASTM F1537), MP35N (ASTM F562)
FootplatesCloverleaf, mesh, and elevated mesh designs Accept 1.0, 1.2, 1.3, 1.5, 1.7, 2.0, and 2.4 mm diameter screwsCP2 and CP4 Titanium (ASTM F67)
Extension ArmsRigid lengths are 20, 40, and 60 mm Flexible lengths are 30, 40, and 60 mmTAN (ASTM F1295), L605 (ASTM F90), MP35N (ASTM F562), Silicone (ASTM F2042)
Bone Screws1.0, 1.2, 1.3, 1.5, 1.7, 2.0, and 2.4 mm diameter 4 – 12 mm lengthsCP 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 either percutaneously or intra-orally.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mandibular body and mandibular ramus

Indicated Patient Age Range

Neonates, infants, children, adolescents, and adults

Intended User / Care Setting

Surgeon, patient, and/or patient caregiver

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)

Non-clinical performance data demonstrates the modified distractor design is an effective correction of the root-cause of the associated recall of the device - reversing due to patient movement:

  • Anatomically simulated motion (i.e. swinging or spinning of the flexible extension arm during treatment) of the redesigned CMFD showed the device does not reverse unintentionally.

Mechanical:

  • Construct bending strength analysis of the redesigned CMFD in comparison to the recalled design of CMFD demonstrates the design changes including material changes do not affect the strength of the distractor construct.
  • Torque Input/Force Output and construct torsional strength testing demonstrates that the device is capable of outputting the force required to distract bone in the intended applications without failing. This testing challenged the construct in torsion by applying an increasing torque (torque input) to the activation end of the device through an extension arm until failure of the device occurred.
  • And, the construct tensile strength of the redesigned CMFD meets the same human factors benchmark as the recalled CMFD. This testing challenged the interface between the distractor and extension arm to ensure the interface can withstand a tensile force based on a human factors benchmark.
  • Engineering analysis of Raised Head Screws in comparison to the predicate PlusDrive Screws from the Synthes Craniomaxillofacial Distraction System (K060138) demonstrates how the Raised Head Screws are expected to have equivalent performance (Torsional Strength, Insertion Torque, Axial Pullout, and Construct Strength) as the Plus Drive Screws when used with the Craniomaxillofacial Distraction System.

Biocompatibility:
Chemical characterization and cleanliness (ISO 10993-18) and cytotoxicity (ISO 10993-5) tests were performed to document that the manufacturing process has not fundamentally altered the composition and cleanliness of the final finished distractor bodies. All other subject devices utilize the same material and manufacturing methods as the previous design of CMFD (K060138) and therefore biocompatibility testing is not required for these devices in this submission.

Sterilization:
The sterilization parameters were validated using the "overkill" method as referenced in Annex D of ANSI/AAMI/ISO 17665-1 in order to assure a Sterility Assurance Level (SAL) of 10-6. The sterility validation of the subject devices was based on Master Products. Master Products are those possessing the most difficult challenges to sterilize via steam, establishing that proposed devices can be cleaned or sterilized considering worst-case conditions and design elements.

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.

Synthes Craniomaxillofacial Distraction System (K060138)

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.

Synthes Curvilinear Distraction System (K121502)

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.

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

May 8, 2017

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

Re: K162594

Trade/Device Name: Craniomaxillofacial Distraction System (CMFD) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: MQN Dated: March 31, 2017 Received: April 3, 2017

Dear Nicholas 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 (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.

1

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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K162594

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.

The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuv Synthes CMF Distraction System is intended for single use only.

Mandible

· The 1.0 mm plates and screws are intended for neonates and infants under the age of 12 months

· The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger

· The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older

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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Image /page/3/Picture/0 description: The image shows the Synthes logo. The logo consists of a stylized symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the word "SYNTHES".

5. 510(k) Summary

Date Prepared: April 24, 2017

5.1.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

5.2.Device

Name of Device: Craniomaxillofacial Distraction System (CMFD) Common or Usual Name(s): External Mandibular Fixator and/or Distractor Classification Name(s): Bone plate Regulatory Class: Class II - 872.4760 Product Code: MQN

5.3.Predicate Devices

Primary Predicate Device:

  • Synthes Craniomaxillofacial Distraction System (K060138)
    Reference Device(s):

  • Synthes Curvilinear Distraction System (K121502)

5.4.Indications for Use

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

The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only.

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Image /page/4/Picture/0 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. A small registered trademark symbol is located to the right of the word.

Mandible

  • The 1.0 mm plates and screws are intended for neonates and infants under the age of ● 12 months
  • The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger
  • . The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older

5.5.Device Description

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the mandibular body and mandibular ramus in adults, adolescents, children, infants, and neonates. The distractor implant consists of several components; the distractor body, footplates, extension arms, and bone screws, many of which are available in a variety of configurations to meet patient and surgeon needs as detailed the table below.

ComponentDistractor BodyFootplatesExtension ArmsBone Screws
Dimensions10, 15, 20, 25, 30,
35, and 40 mm
lengthsCloverleaf, mesh,
and elevated mesh
designs
Accept 1.0, 1.2, 1.3,
1.5, 1.7, 2.0, and 2.4
mm diameter
screwsRigid lengths are 20,
40, and 60 mm
Flexible lengths are
30, 40, and 60 mm1.0, 1.2, 1.3, 1.5, 1.7,
2.0, and 2.4 mm
diameter
4 – 12 mm lengths
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 either percutaneously or intra-orally.

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Image /page/5/Picture/0 description: The image shows the Synthes logo. The logo consists of a stylized symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the word "SYNTHES". The logo is black and white.

5.6.Comparison to Predicate Devices

Indications:

In the previous clearance of CMFD (K060138), the indications for use were separated by the naming convention "CMF Distraction System" and "Pediatric CMF Distraction System" where the 1.0 mm and 1.3 mm plates and screws were considered the Pediatric CMF Distraction System and the 1.5 mm and 2.0 mm plates and screws were considered the CMF Distraction System. In this submission, the indications for use statement was altered to detail the exact age range applicable to each plate and screw size to ensure clarity in the pediatric use of the device, and to ensure the use of 1.3 mm plates and screws was aligned with the Synthes Curvilinear Distractor (K121502) to include children 4 years of age and younger. No other changes were made to the indications for use since the previous clearance of CMFD (K060138). CMFD remains intended for correction of deformities and post-traumatic defects of the mandible through gradual bone distraction in both adult and pediatric patients. The changes to the indications for use since the previous clearance do not raise any new questions of safety and do not result in a new intended use not already addressed by the predicate devices.

Technology

Technological Similarities of the subject Craniomaxillofacial Distraction System (CMFD) to CMFD (K060138):

In comparison to the previously cleared design of CMFD (K060138), the principle design and function of the device remains unchanged. The distractor system consists of a distractor body, extension arms, footplates, screws, and instruments. Footplates are assembled to the distractor body and fixation of the footplates to bone is accomplished using screws. Distraction of the bone is accomplished by the surgeon, patient, and/or patient caregiver using an instrument to drive the advancement/lead screw in the distractor body. Rotation of the advancement/lead screw translates the footplates and distracts the bones.

Technological Differences of the subject Craniomaxillofacial Distraction System (CMFD) to CMFD (K060138):

In comparison to the previously cleared design of CMFD (K060138), the redesigned CMFD distractor bodies feature a spring clip mechanism to prevent reversing of the device due to patient movement. Components of the distractor body assembly were changed accordingly to accommodate the spring clip mechanism. Changes include material and dimensional changes. The design changes were made to address the root-cause of recall Z-2148-2014. Non-clinical performance data provided in the submission is detailed below in Section 5.7, and demonstrates that the differences in technological characteristics of the subject and predicate device do not raise new questions of safety and efficacy.

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5.7.Non-clinical performance data

Non-clinical performance data demonstrates the modified distractor design is an effective correction of the root-cause of the associated recall of the device - reversing due to patient movement:

  • . Anatomically simulated motion (i.e. swinging or spinning of the flexible extension arm during treatment) of the redesigned CMFD showed the device does not reverse unintentionally.
    Non-clinical performance supports that the design of the subject CMFD System is substantially equivalent to the primary predicate device.

Mechanical:

  • Construct bending strength analysis of the redesigned CMFD in comparison to the . recalled design of CMFD demonstrates the design changes including material changes do not affect the strength of the distractor construct.
  • Torque Input/Force Output and construct torsional strength testing demonstrates that the device is capable of outputting the force required to distract bone in the intended applications without failing. This testing challenged the construct in torsion by applying an increasing torque (torque input) to the activation end of the device through an extension arm until failure of the device occurred.
  • . And, the construct tensile strength of the redesigned CMFD meets the same human factors benchmark as the recalled CMFD. This testing challenged the interface between the distractor and extension arm to ensure the interface can withstand a tensile force based on a human factors benchmark.
  • Engineering analysis of Raised Head Screws in comparison to the predicate PlusDrive Screws from the Synthes Craniomaxillofacial Distraction System (K060138) demonstrates how the Raised Head Screws are expected to have equivalent performance (Torsional Strength, Insertion Torque, Axial Pullout, and Construct Strength) as the Plus Drive Screws when used with the Craniomaxillofacial Distraction System.

Biocompatibility:

Chemical characterization and cleanliness (ISO 10993-18) and cytotoxicity (ISO 10993-5) tests were performed to document that the manufacturing process has not fundamentally altered the composition and cleanliness of the final finished distractor bodies. All other subject devices utilize the same material and manufacturing methods as the previous design of CMFD (K060138) and therefore biocompatibility testing is not required for these devices in this submission.

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Image /page/7/Picture/0 description: The image shows the Synthes logo. The logo consists of a stylized symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the word "SYNTHES". The logo is black and white.

Sterilization:

The sterilization parameters were validated using the "overkill" method as referenced in Annex D of ANSI/AAMI/ISO 17665-1 in order to assure a Sterility Assurance Level (SAL) of 10 °. The sterility validation of the subject devices was based on Master Products. Master Products are those possessing the most difficult challenges to sterilize via steam, establishing that proposed devices can be cleaned or sterilized considering worst-case conditions and design elements.

5.8.Clinical performance data

No clinical performance data is included in this submission.

5.9.Substantial Equivalence

The information provided in this submission demonstrates:

  • The modified distractor design is an effective correction of the root-cause of the associated recall
  • . The proposed devices are at least as safe and effective as the predicates
  • . The proposed CMFD System has the same intended use as the predicate devices

The information provided in this submission supports substantial equivalence.