510(k) Report

510(k) · Cleared

Cleared

Accolade HFX Femoral Stem

K051741510(k) TraditionalCleared Sep 26, 200590-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

Stryker Orthopaedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Sep 26, 2005 as substantially equivalent to K994366 (Howmedica Osteonics Corp., 2000) after a 90-day review. Its family tree reaches back 3 generations to 1994. 18 later devices descend from it.

Decided
Sep 26, 2005
Review
90 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K941141 (1994). 8 ancestors in all, the oldest K921301 (1994). 18 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 3 other ancestors1994: 1 other ancestor2016: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2022: 4 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2025: 4 descendants cleared2024: 2 descendants clearedK941141 · Precision Ostelock SP Femoral Component · Howmedica Corp. · 1994K972228 · Meridian Titanium Femoral Stems · Howmedica, Inc. · 1997K994366 · TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem · Howmedica Osteonics Corp. · 2000 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 9 descendants3 generations forward: 7 descendants K994366 · TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem · Howmedica Osteonics Corp. · 2000 · recalledK972228 · Meridian Titanium Femoral Stems · Howmedica, Inc. · 1997K941141 · Precision Ostelock SP Femoral Component · Howmedica Corp. · 19940
  1. Root · 3 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
  2. 2 generations backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
  3. 1 generation backK994366 TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemHowmedica Osteonics Corp. · 2000 · Recalled
  4. This deviceK051741 Accolade HFX Femoral StemStryker Orthopaedics · 2005
  5. Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  6. Descendant · cites it directly · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  7. Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
  8. Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
  9. Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2016: 12018: 12019: 22020: 12021: 12022: 42023: 12024: 22025: 42026: 1
2016high 4 (2022) · low 0 (2017)2026

Most influential descendants

Showing 5 of 18 · See all
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · cites it directly8descendants
  • K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
  • K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
  • K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K941141Precision Ostelock SP Femoral ComponentHowmedica Corp.1994—
−2K972228Meridian Titanium Femoral StemsHowmedica, Inc.1997—
−1K994366TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemHowmedica Osteonics Corp.20003
0 (this device)K051741Accolade HFX Femoral StemStryker Orthopaedics2005—
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics20161
+1K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20182
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.20201

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199530
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201810
201920
202010
202110
202240
202310
202420
202540
202610
FIG. 1 — Lineage of K051741, 1994–2026Source: 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 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? (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
*K994366TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem
Summary page 2
…tion of the substantial equivalence of the Accolade® hip stem is based on its similarities in intended use, design and sterilization to the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000). Predicate device information is located in Appendix E. DEPARTMENT OF HEALTH & HUMAN…
Howmedica Osteonics Corp.20003

Also cleared against K994366: 5 other devices →

What descends from it? (18)

See all 18

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics201617
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20188

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 11 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
  • 4 of the 8 ancestors have a recall of any class.
  • Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
  • 5 other devices also cite its predicate K994366.

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.

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?

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

Rheumatoid arthritis;

Correction of functional deformity;

Revision procedures where other treatments or devices have failed; and,

Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Indications for use as stated in the FDA summary.

Also cleared against K994366

5 other devices cite the same predicate.

  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 20122 recalls
  • K120578Accolade II Hip StemHowmedica Osteonics · 20121 recall
  • K103479Novel Tapered Hip StemStryker Corp. · 2011
  • K052542Accolade RPS Hip StemStryker Orthopaedics · 2005

More from Stryker Orthopaedics

24 FDA decisions under this applicant name. See the company

  • K211703Insignia Hip StemStryker Orthopaedics · 2021
  • K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall

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/K051741 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051741: Accolade HFX Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051741

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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