(89 days)
No
The description focuses on a "design process" that translates imaging and other inputs into patient-specific implants and instruments, but it does not mention or imply the use of AI or ML algorithms for this process. The performance studies are mechanical tests, not related to algorithmic performance.
Yes.
The device is used to reconstruct the pelvis and/or hip joint due to disease, deformity, trauma, or failed treatments, which are therapeutic interventions aimed at restoring function and alleviating symptoms.
No
The device is a system for personalized pelvic and hip reconstruction, including implants and instruments, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The My3D® Personalized Pelvic Reconstruction system is a surgical implant and associated instruments used for the physical reconstruction of the pelvis and hip joint. It is directly implanted into the patient's body.
- Intended Use: The intended use clearly describes a surgical procedure for reconstruction, not the analysis of biological samples.
The device is a medical device, specifically a surgical implant system, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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 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.
Product codes
LPH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
imaging
Anatomical Site
pelvis and/or hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
| 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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3
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 Road | ||
| Parsippany, NJ, 07054, USA | ||
| Contact: | Matthew Vernak | |
| VP, Quality and Regulatory | ||
| Onkos Surgical, Inc. | ||
| 77 East Halsey Road | ||
| Parsippany, NJ, 07054, USA | ||
| Phone: (551) 579-1081 | ||
| Email: mvernak@onkossurgical.com | ||
| Prepared by: | Veronica Fleck | |
| Director, Regulatory Affairs | ||
| MCRA, LLC | ||
| 803 7th Street NW, Floor 3 | ||
| Washington, DC 20001 | ||
| Email: vfleck@mcra.com | ||
| Phone: 202.552.5837 | ||
| Date Prepared: | November 1, 2022 | |
| Classifications: | 21 CFR §888.3358 | |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous | |
| coated 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
4
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.
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 Pelvic | ||
| Reconstruction | 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 and | ||
| Large Fragment Osteosynthesis | ||
| Plating System (locking screw | ||
| components) | Narang Medical | |
| Limited | 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).