ONE Planner Hip

K210653 · Orthosoft D/B/A Zimmer Cas · LLZ · Jul 7, 2021 · Radiology

Device Facts

• Record ID: K210653
• Device Name: ONE Planner Hip
• Applicant: Orthosoft D/B/A Zimmer Cas
• Product Code: LLZ · Radiology
• Decision Date: Jul 7, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

Device Story

ONE Planner™ Hip is a web-based preoperative surgical planning software for total hip arthroplasty. It accepts X-ray images as input; performs automated templating; enables 2D sizing and positioning of implants; calculates biomechanical measurements (leg length, femoral offset); and performs functional analysis of pelvic parameters (e.g., pelvic tilt, cup orientation). Surgeons use the interactive interface to adjust the surgical plan, visualize anatomy, and select implant components. The output is a preoperative surgical plan used to guide component selection and placement. The device is intended for use by orthopedic surgeons in a clinical setting to improve surgical planning accuracy and patient outcomes.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical testing, including software verification and validation per IEC 62304 and usability/performance testing.

Technological Characteristics

Web-based software application for preoperative surgical planning. Features include automated templating system, image processing tools, and interactive user interface for implant sizing/positioning. Operates on X-ray image inputs. Software level of concern: moderate.

Indications for Use

Indicated for orthopedic surgeons performing preoperative surgical planning for primary total hip arthroplasty.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Corin Optimized Positioning System Insight (K192656)

Reference Devices

• G7 Acetabular Systems (K121874, K142746, K142882, K140669, K150522, K190660, K190656)
• Taperloc Complete Stems (K101086, K103755, K110400, K120030, K200196)
• Echo Bi-Metric Stems (K070274, K143009, K150503)
• Avenir Complete (K182048, K192189)
• Avenir Muller and Cemented Hip Stems (K123392, K131884, K193030)

Submission Summary (Full Text)

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July 7, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Orthosoft d/b/a Zimmer CAS % Mr. Paul Hardy Regulatory Affairs Associate Director 75 Queen Street, Suite 3300 Montreal, Quebec H3C 2N6 CANADA

# Re: K210653

Trade/Device Name: ONE Planner™ Hip Regulation Number: 21 CFR 892.2050 Regulation Name: Medical imaging management and processing system Regulatory Class: Class II Product Code: LLZ, LZO, PBI, LPH Dated: May 25, 2021 Received: June 1, 2021

Dear Mr. Hardy:

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K210653

Device Name ONE Planner™ Hip

Indications for Use (Describe)

ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|--|
| <div> <span> </span> Prescription Use (Part 21 CFR 201 Subpart D) </div> | |
| <div> <span> </span> Over-The-Counter Use (21 CFR 201 Subpart C) </div> | |

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) Summary

In accordance with 21 CFR \$807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ONE Planner TM Hip 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

- Sponsor : Orthosoft, Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal, QC, CANADA H3C 2N6 Establishment Registration Number: 9617840 Contact Person(s): Paul Hardy Regulatory Affairs Associate Director Telephone: [phone] [e-mail] Dave Bierhuizen Quality Assurance and Regulatory Affairs Manager [e-mail] Date: June 29, 2021 Trade Name: ONE Planner™ Hip Subject Device: Common Name: Image Processing System Product Code(s) / Classification Name (s): LLZ - Picture Archiving and Communications System to ● Medical imaging management and processing system (21 CFR 892.2050). . LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353) . PBI - Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310) LPH- Hip joint metal/polymer/metal semi-constrained porous-. coated uncemented prosthesis (21 CFR 888.3358
## Predicate Device(s):

| Manufacturer | Device Name | 510(k) Number |
|--------------|--------------------------------------------|---------------|
| Corin | Corin Optimized Positioning System Insight | K192656 |

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| Purpose and Device<br>Description: | ONE Planner™ Hip (OPH) is an interactive software application<br>intended to be used as a preoperative tool for Total Hip<br>Arthroplasty. It enables 2D sizing and positioning of implants in<br>the patient's anatomy, calculates biomechanical measurements and<br>performs functional analysis based on the patient's pelvic<br>kinematics. The biomechanical measurements include<br>measurements related to leg length and femoral offset. The<br>functional analysis includes determination of pelvic parameters<br>(e.g. pelvic tilt), and cup orientation calculations.<br><br>The software application consists of an automated templating<br>system and a web-based templating user interface. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | ONE Planner™ Hip is intended for use as preoperative surgical<br>planning software to aid orthopedic surgeons in component<br>selection, sizing and placement for primary total hip arthroplasty |
| Summary of<br>Technological<br>Characteristics: | The rationale for substantial equivalence is based on consideration<br>of the following characteristics:<br>• Indications for Use: ONE Planner™ Hip and the predicate<br>device have the same Indications for Use.<br>• Design Features: Both devices have the following features:<br>Ο ONE Planner™ Hip and the predicate device use input files<br>consisting of X-ray images.<br>Ο ONE Planner™ Hip and the predicate device provide image<br>processing tools.<br>Ο ONE Planner™ Hip and the predicate device provide<br>preoperative sizing values.<br>Ο ONE Planner™ Hip and the predicate device provide<br>functional analysis of pelvic parameters<br>Ο ONE Planner™ Hip and the predicate device provide<br>interactive adjustment of the preoperative surgical plan<br>Ο ONE Planner™ Hip and the predicate device provide tools<br>for visualization and to perform measurements, and to<br>choose size and position implants.<br>Ο ONE Planner™ Hip and the predicate device export a<br>preoperative surgical plan. |
| Compatible Devices: | ONE Planner™ Hip can be used with the following implant<br>systems:<br><br>G7 Acetabular Systems (K121874, K142746, K142882, K140669,<br>K150522, K190660, K190656)<br>Taperloc Complete Stems (K101086, K103755, K110400,<br>K120030, K200196) |

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Echo Bi-Metric Stems (K070274, K143009, K150503) Avenir Complete (K182048, K192189) Avenir Muller and Cemented Hip Stems (K123392, K131884, K193030)

ONE Planner™ Hip has been evaluated through the following nonclinical testing:

## · Software Verification & Validation Testing

Software verification and validation testing was conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software is considered a "moderate" level of concern, a malfunction in the device could lead to a minor iniurv. The testing demonstrates that the ONE Planner™ Hip does not introduce new questions of safety and effectiveness as compared to the predicate device.

# • Non-Clinical Testing

Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended.

## · Clinical Testing

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

Substantial Equivalence Conclusion:

The subject device has the same intended use, same indications for use, similar technological characteristics and principles of operation as the predicate device. The differences between the subject device and the predicate device does not introduce new types of safety and effectiveness questions. Therefore, the subject device is at least as safe and effective as the legally marketed predicate device.

Summary of Performance Data (Nonclinical and/or Clinical):