510(k) Report

510(k) · Cleared

Cleared

b-ONE® Total Hip System

K173380510(k) TraditionalCleared Aug 30, 2018304-day reviewClass II21 CFR 888.3353

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

B-One Ortho, Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Aug 30, 2018 as substantially equivalent to K052718 (Howmedica Osteonics Corp., 2005) and 7 other predicates after a 304-day review. Its family tree reaches back 10 generations to 1981.

Decided
Aug 30, 2018
Review
304 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
8

Its longest line of descent runs back 10 generations to K810258 (1981). 112 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2011: 2 other ancestors2009: 2 other ancestors2005: 6 other ancestors2001: 4 other ancestors2000: 7 other ancestors1987: 1 other ancestor2010: 4 other ancestors2003: 5 other ancestors2002: 7 other ancestors1999: 3 other ancestors1998: 3 other ancestors1997: 7 other ancestors1994: 15 other ancestors1991: 3 other ancestors2008: 1 other ancestor2007: 3 other ancestors1996: 7 other ancestors1995: 12 other ancestors1990: 1 other ancestor1983: 1 other ancestor2004: 1 other ancestor1992: 3 other ancestors1986: 1 other ancestor1985: 1 other ancestor1993: 1 other ancestorReference device: K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledReference device: K161569 · Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2016Reference device: K112802 · Pipeline Total Hip System · Pipeline Orthopedics · 2012Reference device: K122158 · PBP Total Hip System · Pipeline Biomedical Products, LLC · 2012Reference device: K111546 · U2 Hip System · United Orthopedic Corp. · 2011 · recalledK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K082996 · Biolox Delta Option Ceramic Heads · Biomet, Inc. · 2009 · recalledK093549 · 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum · Biomet Manufacturing Corp · 2009K121874 · G7 Acetabular System · Biomet Manufacturing Corp · 2012 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 24 other ancestors3 generations back: 24 other ancestors4 generations back: 19 other ancestors5 generations back: 19 other ancestors6 generations back: 7 other ancestors7 generations back: 2 other ancestors K121874 · G7 Acetabular System · Biomet Manufacturing Corp · 2012 · recalledK093549 · 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum · Biomet Manufacturing Corp · 2009K082996 · Biolox Delta Option Ceramic Heads · Biomet, Inc. · 2009 · recalledK073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations between
  3. 3 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
  4. 2 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
  5. 1 generation backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  6. This deviceK173380 b-ONE® Total Hip SystemB-One Ortho, Corp. · 2018
Show all 10 generations
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 4 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 3 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
  9. 2 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
  10. 1 generation backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  11. This deviceK173380 b-ONE® Total Hip SystemB-One Ortho, Corp. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−9K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−8K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−7K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−6K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−5K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−4K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−3K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.20094
−2K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M…Biomet Manufacturing Corp2009—
−1K121874G7 Acetabular SystemBiomet Manufacturing Corp20123
0 (this device)K173380b-ONE® Total Hip SystemB-One Ortho, Corp.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198610
198710
199010
199130
199230
199310
1994150
1995120
199670
199770
199830
199930
200070
200140
200270
200350
200410
200560
200730
200810
200920
201040
201120
201210
FIG. 1 — Lineage of K173380, 1981–2018Source: 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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (8)

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
*K052718V40 Biolox Delta Ceramic Femoral Heads
Summary page 4
…Screw, fixation, bone, smooth or threaded metallic bone fixation (888.3040) fastener Legally Marketed Predicate K052718, StrykerV40™ Biolox® delta Ceramic Femoral Heads Devices to Which Substantial K010757, Stryker V40™ Femoral Head Components E…
Howmedica Osteonics Corp.20052
*K010757Lfit V40 Femoral Head Components
Summary page 4
…(888.3040) fastener Legally Marketed Predicate K052718, StrykerV40™ Biolox® delta Ceramic Femoral Heads Devices to Which Substantial K010757, Stryker V40™ Femoral Head Components Equivalence is Claimed: K103479 Accolade II Hip Stem…
Howmedica Osteonics Corp.20014
*K103479Novel Tapered Hip Stem
Summary page 4
…K052718, StrykerV40™ Biolox® delta Ceramic Femoral Heads Devices to Which Substantial K010757, Stryker V40™ Femoral Head Components Equivalence is Claimed: K103479 Accolade II Hip Stem K001448 Stryker Trident Acetabular Shells: HA over PPS…
Stryker Corp.2011—
*K001448Trident Acetabular Shells: PS-HA
Summary page 4
…ces to Which Substantial K010757, Stryker V40™ Femoral Head Components Equivalence is Claimed: K103479 Accolade II Hip Stem K001448 Stryker Trident Acetabular Shells: HA over PPS K121874 Biomet G7 Acetabular System…
Howmedica Osteonics Corp.2000—
*K121874G7 Acetabular System
Summary page 4
…s Claimed: K103479 Accolade II Hip Stem K001448 Stryker Trident Acetabular Shells: HA over PPS K121874 Biomet G7 Acetabular System K120370 Zimmer Continuum Acetabular System (UHMWPE+VitE)…
Biomet Manufacturing Corp20123
*K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners
Summary page 4
…K001448 Stryker Trident Acetabular Shells: HA over PPS K121874 Biomet G7 Acetabular System K120370 Zimmer Continuum Acetabular System (UHMWPE+VitE) K091508 Zimmer Continuum Acetabular System (UHM…
Zimmer, Inc.2012—
*K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System
Summary page 4
…K121874 Biomet G7 Acetabular System K120370 Zimmer Continuum Acetabular System (UHMWPE+VitE) K091508 Zimmer Continuum Acetabular System (UHMWPE) K873251Stryker Self-Tapping Acetabular Screw Legal…
Zimmer, Inc.20093
*K873251Omnifit Bone Screw
Summary page 4
…70 Zimmer Continuum Acetabular System (UHMWPE+VitE) K091508 Zimmer Continuum Acetabular System (UHMWPE) K873251Stryker Self-Tapping Acetabular Screw Legally Marketed Reference K082844 Biolox Ceramic Femoral Heads Devices Used to Sup…
Osteonics Corp.198729
†K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081
†K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2016—
†K112802Pipeline Total Hip SystemPipeline Orthopedics2012—
†K122158PBP Total Hip SystemPipeline Biomedical Products, LLC2012—
†K111546U2 Hip SystemUnited Orthopedic Corp.20111

Also cleared against K052718: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • 38 of the 112 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K052718.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for…

Read the full statement (124 words)

The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with

a severely disabled hip joint and/or hip damage due to the following conditions:

Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.

The b-ONE® Total Hip System is intended for cementless use only.

b-ONE® Total Hip System components are not intended for use with other total hip systems.

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

Also cleared against K052718

5 other devices cite the same predicate.

  • K23402522.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
  • K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 20201 recall
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 20081 recall
  • K071830Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 20071 recall

More from B-One Ortho, Corp.

13 FDA decisions under this applicant name. See the company

  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K253357b-ONE® Bipolar HeadB-One Ortho, Corp. · 2026
  • K240528b-ONE® Total Hip SystemB-One Ortho, Corp. · 2024
  • K222431b-ONER MOBIO Total Knee SystemB-One Ortho, Corp. · 2022
  • K213673b-ONE MOBIO Total Knee SystemB-One Ortho, Corp. · 2022

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K173380 · printed Nov 5, 2026

Cite this page

510(k) Report. “K173380: b-ONE® Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173380

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