510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

My3D® Personalized Pelvic Reconstruction

K212815510(k) TraditionalCleared Jul 6, 2022306-day reviewClass II21 CFR 888.3358Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Onkos Surgical · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jul 6, 2022 as substantially equivalent to K983035 (Biomet, Inc., 1998) after a 306-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 2 times.

Decided
Jul 6, 2022
Review
306 days
Class
Class II
Product code
LPH
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K983035 (1998). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2023: 1 descendant clearedReference device: K190044 · VSP Orthopedics System · 3D Systems, Inc. · 2019Reference device: K211244 · VSP® Orthopedics System · 3D Systems · 2021Reference device: K894334 · Second Generation Knee System · Orthomet, Inc. · 1989Reference device: K002149 · Lineage Acetabular System · Wrightmedicaltechnologyinc · 2000Reference device: K110135 · Polarcup Dual Mobility System · Smith & Nephew, Inc. · 2011Reference device: K130728 · Polarstem Standard and Lateral Femoral Stems with TI/HA · Smith & Nephew, Inc. · 2013 · recalledReference device: K143739 · POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA · Smith & Nephew, Inc. · 2015 · recalledReference device: K151902 · REDAPT¿ Revision Femoral System · Smith & Nephew, Inc. · 2015Reference device: K162303 · REDAPT Sleeved Monolithic Revision Stems · Smith & Nephew, Inc. · 2017Reference device: K021673 · Total Hip Femoral Head - 12/14 Taper · Smith & Nephew, Inc. · 2002 · recalledReference device: K963509 · Global Taper Tapered Hip System, GT Spectron · Smith & Nephew Richards, Inc. · 1997K983035 · Custom Flanged Acetabular Component · Biomet, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K983035 · Custom Flanged Acetabular Component · Biomet, Inc. · 19980
  1. Root · 1 generation backK983035 Custom Flanged Acetabular ComponentBiomet, Inc. · 1998
  2. This deviceK212815 My3D® Personalized Pelvic ReconstructionOnkos Surgical · 2022
  3. Descendant · cites it directly · 0 of its ownK223348 My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc. · 2023 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K223348My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983035Custom Flanged Acetabular ComponentBiomet, Inc.1998—
0 (this device)K212815My3D® Personalized Pelvic ReconstructionOnkos Surgical2022—
+1K223348My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc.20232

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K212815, 1998–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K983035Custom Flanged Acetabular Component
Summary page 4
…porous-coated uncemented prosthesis Regulatory Class: II Product Code(s): LPH 5.3. Predicate Devices Biomet’s Patient Matched Pelvic Implant, K983035 (Primary Predicate) 3D System’s VSP® Orthopedics System, K190044 and K211244 (Reference Device) MicroPort’s Second Generation Kne…
Biomet, Inc.1998—
†K190044VSP Orthopedics System3D Systems, Inc.2019—
†K211244VSP® Orthopedics System3D Systems2021—
†K894334Second Generation Knee SystemOrthomet, Inc.1989—
†K002149Lineage Acetabular SystemWrightmedicaltechnologyinc2000—
†K110135Polarcup Dual Mobility SystemSmith & Nephew, Inc.2011—
†K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc.20131
†K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.20151
†K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.2015—
†K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.2017—
†K021673Total Hip Femoral Head - 12/14 TaperSmith & Nephew, Inc.20021
†K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc.1997—

Also cleared against K983035: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K223348My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc.20230

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 24, 2026Class IIZ-0091-2027Labeling mix-upsPersonalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Jul 24, 2026Class IIZ-0090-2027Labeling mix-upsPersonalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K223348 (Onkos Surgical, Inc., 2023) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K983035.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

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…

Read the full statement (126 words)

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 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.

Indications for use as stated in the FDA summary.

Also cleared against K983035

3 other devices cite the same predicate.

  • K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc. · 2010
  • K030861HA Pmi Flanged Acetabular ComponentBiomet, Inc. · 2003
  • K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000

More from Onkos Surgical

6 FDA decisions under this applicant name. See the company

  • DEN210058ELEOSx™ Limb Salvage SystemOnkos Surgical · 2024
  • K211677ELEOS Limb Salvage SystemOnkos Surgical · 2021
  • K203815ELEOS Limb Salvage System with BioGripOnkos Surgical · 20213 recalls
  • K203588ELEOS™ Limb Salvage SystemOnkos Surgical · 20213 recalls
  • K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K212815 · printed Nov 4, 2026

Cite this page

510(k) Report. “K212815: My3D® Personalized Pelvic Reconstruction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212815

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026