510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

My3D® Personalized Pelvic Reconstruction

K223348510(k) TraditionalCleared Jan 30, 202389-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, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 30, 2023 as substantially equivalent to K212815 (Onkos Surgical, 2022) after an 89-day review. Its family tree reaches back 2 generations to 1998. It has been recalled 2 times.

Decided
Jan 30, 2023
Review
89 days
Class
Class II
Product code
LPH
Recalls
2
Predicates
1

Its longest line of descent runs back 2 generations to K983035 (1998). No later device cites it as a predicate yet.

Reference device: K150561 · NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System · Narang Medical Limited · 2015K983035 · Custom Flanged Acetabular Component · Biomet, Inc. · 1998K212815 · My3D® Personalized Pelvic Reconstruction · Onkos Surgical · 2022 · recalled1995200020052010201520202025
K212815 · My3D® Personalized Pelvic Reconstruction · Onkos Surgical · 2022 · recalledK983035 · Custom Flanged Acetabular Component · Biomet, Inc. · 19980
  1. Root · 2 generations backK983035 Custom Flanged Acetabular ComponentBiomet, Inc. · 1998
  2. 1 generation backK212815 My3D® Personalized Pelvic ReconstructionOnkos Surgical · 2022 · Recalled
  3. This deviceK223348 My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K983035Custom Flanged Acetabular ComponentBiomet, Inc.1998—
−1K212815My3D® Personalized Pelvic ReconstructionOnkos Surgical20222
0 (this device)K223348My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc.2023—
FIG. 1 — Lineage of K223348, 1998–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K212815My3D® Personalized Pelvic Reconstruction
Summary page 5
…Manufacturer K-Number My3D® Personalized Pelvic Onkos Surgical, Inc. K212815 Reconstruction Reference Devices: The subject locking screw components of the My3D® Personalized Pelvic Reconstruction…
Onkos Surgical20222
†K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited2015—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 23.6 years on median.
  • 1 of the 2 ancestors has a recall of any class.

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. 2023, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Onkos Surgical, Inc.

5 FDA decisions under this applicant name. See the company

  • K253066ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc. · 2026
  • K252920ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc. · 2025
  • K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc. · 2018
  • K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 201611 recalls

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/K223348 · printed Nov 4, 2026

Cite this page

510(k) Report. “K223348: 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/K223348

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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