MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

K211313 · Synthes (USA) Products, LLC · KTT · May 25, 2021 · Orthopedic

Device Facts

• Record ID: K211313
• Device Name: MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
• Applicant: Synthes (USA) Products, LLC
• Product Code: KTT · Orthopedic
• Decision Date: May 25, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The DePuy Synthes MaxFrame™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: - · fracture fixation (open and closed) - · pseudoarthrosis of long bones - limb lengthening (epiphyseal or metaphyseal distraction) joint arthrodesis - · infected fractures or nonunions - · correction of bony or soft tissue deformities - · correction of segmental defects

Device Story

External ring fixation system; includes hardware (schanz screws, pins, struts, rings) and MAXFRAME 3D II software. Software assists surgeons in treatment planning for bone/soft tissue deformities. Inputs: X-rays/radiographic images. Processing: software-based planning for deformity correction and frame identification. Output: treatment plan for surgeon. Used in clinical settings by surgeons. Benefits: efficient planning, simplified upgrades, improved functionality for frame identification and deformity treatment.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical software verification and validation testing confirming outputs meet input requirements and user needs.

Technological Characteristics

External ring fixation hardware (schanz screws, pins, struts, rings). Software: MAXFRAME 3D II (Moderate Level of Concern). Connectivity: Web-based software for treatment planning. Sterilization: Hardware components (not specified).

Indications for Use

Indicated for adults, children (3-12), and adolescents (12-21) with fused growth plates or where hardware does not cross growth plates for fracture fixation, pseudoarthrosis, limb lengthening, joint arthrodesis, infected fractures/nonunions, and correction of bony/soft tissue deformities or segmental defects.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• DePuy Synthes MAXFRAME™ Multi-Axial Correction System (K161417)

Submission Summary (Full Text)

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May 25, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Synthes (USA) Products, LLC Suchitra Basu Associate Director, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380

## Re: K211313

Trade/Device Name: MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: OSN, KTT Dated: April 29, 2021 Received: April 30, 2021

## Dear Suchitra Basu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ting Song, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number (if known) K211313

Device Name

MaxFrame™ Multi-Axial Correction System

#### Indications for Use (Describe)

The DePuy Synthes MaxFrame™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware:

- · fracture fixation (open and closed)
- · pseudoarthrosis of long bones
- · limb lengthening (epiphyseal or metaphyseal distraction)
- joint arthrodesis
- · infected fractures or nonunions
- · correction of bony or soft tissue deformities
- · correction of segmental defects

| 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 logo for DePuy Synthes Trauma. The logo consists of a circular design on the left, followed by the text "DePuy Synthes" in a bold, sans-serif font. Below "DePuy Synthes" is the word "TRAUMA" in a smaller, sans-serif font. Underneath the word "TRAUMA" is the text "COMPANIES OF Johnson & Johnson" in a smaller font.

# 6 510(k) Summary

# K211313

| Sponsor | Synthes | Address |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Primary Contact | Suchitra Basu, PhD, RAC<br>Associate Director, Regulatory Affairs<br>DePuy Synthes | 1301 Goshen Parkway<br>West Chester, PA USA<br>T: 610-719-5448<br>Email: [e-mail] |
| Secondary Contact | Thomas Shea<br>Regulatory Affairs Manager<br>DePuy Synthes | 1301 Goshen Parkway<br>West Chester, PA USA<br>T: 610-719-5679<br>Email: [e-mail] |
| Date Prepared | April 27, 2021 | |
| Proprietary Name | MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) | |
| Device Name | MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) | |
| Common Name | Software for Diagnosis/Treatment; Single/multiple component metallic bone<br>fixation appliances | |
| Classification | Class II<br>Product Code(s): OSN (Software for Diagnosis/Treatment),<br>KTT (Appliance, fixation, nail/blade/plate combination, multiple components) | |
| Predicate<br>Device(s) | DePuy Synthes MAXFRAME™ Multi-Axial Correction System (K161417) | |
| Reference<br>Device(s) | None | |
| Reason for<br>Submission | To introduce MAXFRAME 3D II Software (software re-write of MaxFrame Web<br>Software) compatible with existing MaxFrame Hardware cleared as a part of the<br>MAXFRAME Multi Axial Correction System in K161417 | |
| Device<br>Description | The DePuy Synthes MAXFRAME™ Multi Axial Correction System, is an<br>external ring fixation system that consists of MAXFRAME Hardware<br>(schanz screws, pins, struts, rings) and MAXFRAME Web Software, used<br>in treatment of soft tissue and bone deformities.<br><br>The subject device MAXFRAME 3D II Software (Moderate Software<br>Level of Concern) is a software re-write of the MAXFRAME Web<br>Software to make it more efficient, simplify software upgrades for<br>functionality and fixing of software anomalies or bugs. Additionally, based<br>on surgeon feedbacks and voice of customer, new functionality has been<br>added around how frames are identified on X-Rays/radiographic images<br>and how the treatment of the deformity can be planned. | |
| Intended Use | The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is intended | |
| Indications for<br>Use | for external fixation of fractured long bones and bones of the foot, limb<br>lengthening, and deformity correction in adult, children* (3-12), and adolescent*<br>(12-21) patient populations. The DePuy Synthes MAXFRAME™ Multi- Axial<br>Correction System utilizes software for assisting surgeons in treatment planning.<br>*in which the growth plates have fused or will not be crossed. | |
| | The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated<br>for the following treatments in adults, and in both children (3-12) and adolescents<br>(12-21) in which the growth plates have fused or will not be crossed with hardware:<br>• fracture fixation (open and closed)<br>• pseudoarthrosis of long bones<br>• limb lengthening (epiphyseal or metaphyseal distraction)<br>• joint arthrodesis<br>• infected fractures or nonunions<br>• correction of bony or soft tissue deformities<br>• correction of segmental defects. | |
| Comparison to<br>Predicate | The DePuy Synthes MAXFRAME 3D II Software has the same indications for<br>use and design (fundamental software architecture) as the MAXFRAME Web<br>Software. It utilizes the existing MAXFRAME hardware, creates a similar patient<br>treatment plan, and has highly comparable functionality and usability to the<br>predicate MAXFRAME Web Software. | |
| Non-clinical<br>Performance<br>Testing | The performance of the subject MAXFRAME 3D II Software has been evaluated<br>by confirming that the outputs meet the input requirements and conform to the<br>user needs and intended uses. | |
| Clinical<br>Performance Data | Clinical data was not necessary for the determination of substantial equivalence. | |
| Substantial<br>Equivalence | The subject device has the same intended use, indications for use, and<br>fundamental principles as the predicate device. It has been adequately compared<br>to the predicate device to demonstrate substantial equivalence | |
| Conclusion | The results of non-clinical performance data in terms of software verification and<br>validation demonstrate that the subject device is substantially equivalent to the<br>predicate device. | |

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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes Trauma, a company that is part of Johnson & Johnson. The logo consists of a geometric design on the left, followed by the company name in bold, blue letters. Below the company name is the word "TRAUMA" in smaller, black letters. At the bottom of the image, the words "COMPANIES OF Johnson & Johnson" are printed in a smaller font.