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FDA 510(k)

My3D® Personalized Pelvic Reconstruction

K-Number: K212815 · 2022-07-06

ApplicantOnkos Surgical
Decision Date2022-07-06
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

My3D® Personalized Pelvic Reconstruction is a medical device manufactured by Onkos Surgical. It received FDA 510(k) clearance on 2022-07-06 under approval number K212815. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the My3D® Personalized Pelvic Reconstruction?

My3D® Personalized Pelvic Reconstruction is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Onkos Surgical. The 510(k) number is K212815.

When was My3D® Personalized Pelvic Reconstruction approved by the FDA?

My3D® Personalized Pelvic Reconstruction received FDA 510(k) clearance on 2022-07-06, under approval number K212815.

What company makes My3D® Personalized Pelvic Reconstruction?

My3D® Personalized Pelvic Reconstruction is manufactured by Onkos Surgical.

What is the FDA product code for My3D® Personalized Pelvic Reconstruction?

The FDA product code for My3D® Personalized Pelvic Reconstruction is LPH.

Related Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT07544667 Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration RECRUITING NCT07254351 Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics RECRUITING

Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026)

Other Devices by Onkos Surgical

K203090ELEOS Limb Salvage System featuring BIOGRIP K211677ELEOS Limb Salvage System K203815ELEOS Limb Salvage System with BioGrip K203588ELEOS™ Limb Salvage System DEN210058ELEOSx™ Limb Salvage System

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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