The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

Device Description

The subject submission adds locking screw component options and associated instrumentation to the subject My3D® Personalized Pelvic Reconstruction system.

The My3D® Personalized Pelvic Reconstruction system is a patient specific combination of single use resection instruments, a pelvic implant, screws, acetabular, and femoral components. The system was developed to address conditions which require reconstruction of the acetabulum and hip joint.

This patient matched device is designed from inputs including imaging, diagnosis, and surgical approach. Together with the surgeon, these inputs are then translated via a design process to create patient specific implants and, if appropriate, instruments to reconstruct the patient's pelvis. If utilized, the patient specific instruments are used to resect the bone and allow for implantation of the patient matched pelvis. The joint is then reconstructed with a cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components.

The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

AI/ML Overview

This FDA 510(k) summary for the My3D® Personalized Pelvic Reconstruction device (K223348) primarily focuses on establishing substantial equivalence to a predicate device (K212815) for an addition of locking screw components and associated instrumentation. It does not describe a clinical study in the typical sense of evaluating diagnostic accuracy or clinical outcomes in human subjects with acceptance criteria.

Instead, the "acceptance criteria" and "study" are related to mechanical performance testing of the newly added locking screw components to demonstrate that they are comparable to existing, legally marketed devices and do not negatively impact the overall device's safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for each test or detailed performance reports with specific values. Instead, it refers to industry standards (ASTM F543-17) and implies that the device met these standards. The "reported device performance" is a general statement that the device underwent testing and a stress analysis, which supported its safety.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Torsional properties testing (ASTM F543-17)	Conformance to ASTM F543-17 standards for screw performance.	The subject device successfully underwent torsional properties testing per ASTM F543-17. (Implies satisfactory performance relative to the standard)
Axial pullout testing (ASTM F543-17)	Conformance to ASTM F543-17 standards for screw performance.	The subject device successfully underwent axial pullout testing per ASTM F543-17. (Implies satisfactory performance relative to the standard)
Driving and removal torque (ASTM F543-17)	Conformance to ASTM F543-17 standards for screw performance.	The subject device successfully underwent driving and removal torque testing per ASTM F543-17. (Implies satisfactory performance relative to the standard)
Stress Analysis	Stress levels in the pelvic implant with locking screws do not create a new worst-case for failure compared to the predicate device.	A stress analysis was performed to support the development of an engineering rationale demonstrating that the subject locking screws do not create a new worst-case for failure of the pelvic implant due to stress.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify exact sample sizes (e.g., number of screws tested) for the mechanical tests. Mechanical testing often involves a smaller number of samples compared to clinical trials, determined by statistical considerations for materials testing.
Data Provenance: The data provenance is from mechanical laboratory testing performed on the device components (locking screws). It is not clinical data from human subjects. The country of origin of the data is not explicitly mentioned but is likely associated with the manufacturer (Onkos Surgical, Inc., based in Parsippany, New Jersey, USA) or a third-party testing facility. This is not retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable in this context. The "ground truth" for mechanical testing is established by engineering principles and adherence to recognized industry standards (e.g., ASTM F543-17). There are no "experts" establishing a clinical ground truth for a test set in this 510(k) submission, as it focuses on mechanical equivalence.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (e.g., 2+1) are typically used in clinical or image-based studies where multiple reviewers assess data and reconcile discrepancies. Mechanical testing results are objective measurements against defined physical standards.

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

No, a MRMC comparative effectiveness study was not done. This device is a physical medical device (pelvic reconstruction system) and not an AI/imaging device that would involve human readers or AI assistance in interpretation.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device and does not involve a standalone algorithm in the way this question implies (e.g., a diagnostic AI algorithm).

7. The type of ground truth used

The "ground truth" for the mechanical testing is based on:

Industry Standards: Adherence to established mechanical testing standards like ASTM F543-17.
Engineering Rationale: Demonstrating through stress analysis that the new components do not compromise the structural integrity or safety of the overall pelvic implant.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of mechanical laboratory testing for a physical device like this. This question is typically relevant for machine learning or AI models.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of submission.

Summary

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January 30, 2023

Onkos Surgical, Inc. Matthew Vernak Vice President, Ouality and Regulatory 77 East Halsev Road Parsippany, New Jersey 07054

Re: K223348

Trade/Device Name: My3D® Personalized Pelvic Reconstruction Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH Dated: December 20, 2022 Received: December 20, 2022

Dear Matthew Vernak:

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

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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) 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Limin Sun-S

Limin Sun, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K223348

Device Name My3D® Personalized Pelvic Reconstruction

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Premarket Notification: My3D® Personalized Pelvic Reconstruction

11. 510(k) Summary

Device Trade Name:	My3D® Personalized Pelvic Reconstruction
Common Name:	Hip Prosthesis
Manufacturer:	Onkos Surgical, Inc.77 East Halsey RoadParsippany, NJ, 07054, USA
Contact:	Matthew VernakVP, Quality and RegulatoryOnkos Surgical, Inc.77 East Halsey RoadParsippany, NJ, 07054, USAPhone: (551) 579-1081Email: mvernak@onkossurgical.com
Prepared by:	Veronica FleckDirector, Regulatory AffairsMCRA, LLC803 7th Street NW, Floor 3Washington, DC 20001Email: vfleck@mcra.comPhone: 202.552.5837
Date Prepared:	November 1, 2022
Classifications:	21 CFR §888.3358
Classification Name:	Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis.
Class:	II
Product Codes:	LPH

Indications for Use:

The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant. The pelvic implant is intended to the remaining pelvic

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anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

Device Description:

The subject submission adds locking screw component options and associated instrumentation to the subject My3D® Personalized Pelvic Reconstruction system.

The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

Primary Predicate Device:

The My3D® Personalized Pelvic Reconstruction system is substantially equivalent to the primary predicate device listed in Table 11-1, with regards to indications, basic design, materials, manufacturing, sizing, and performance.

Device Name	Manufacturer	K-Number
My3D® Personalized PelvicReconstruction	Onkos Surgical, Inc.	K212815

Table 11-1: Primary Predicate Device

Reference Devices:

The subject locking screw components of the My3D® Personalized Pelvic Reconstruction system are substantially equivalent to the reference devices listed in Table 11-2, with respect to design, materials, sizing, and mechanical performance. The NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System (K150561) is referenced in support of the mechanical performance testing methodology for the subject device.

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Device Name	Manufacturer	K-Number
NET Brand Small Fragment andLarge Fragment OsteosynthesisPlating System (locking screwcomponents)	Narang MedicalLimited	K150561

Table 11-2: Reference Devices

Performance Testing Summary:

The subject device underwent torsional properties testing per ASTM F543-17, axial pullout testing per ASTM F543-17, and driving and removal torque testing per ASTM F543-17. Additionally, a stress analysis was performed to support the development of an engineering rationale demonstrating that the subject locking screws do not create a new worst-case for failure of the pelvic implant due to stress.

Comparison of Technological Characteristics:

The subject device was demonstrated to be substantially equivalent to the My3D® Personalized Pelvic Reconstruction primary predicate devices (K212815) with respect to indications, design, materials, manufacturing, sizing, principles of operation, and performance.

Conclusion:

The subject My3D® Personalized Pelvic Reconstruction system and primary predicate device cited above have the same intended use, indications for use, technological characteristics, are made of identical materials, and include similar implant designs. The subject and primary predicate devices are packaged in identical materials, are both provided non-sterile, and are intended to be sterilized by the end user via steam sterilization (autoclave). Based on the test results and supporting documentation provided in this 510(k) premarket notification, the subject My3D Personalized Pelvic Reconstruction has been demonstrated to be as safe, as effective, and is substantially equivalent to the legally marketed primary predicate, My3D® Personalized Pelvic Reconstruction (K212815).

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.