510(k) Report

510(k) · Cleared

Cleared

Accolade C Femoral Component

K002320510(k) TraditionalCleared Sep 14, 200045-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

Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Sep 14, 2000 as substantially equivalent to K936126 (Howmedica, Inc., 1994) and 3 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1991.

Decided
Sep 14, 2000
Review
45 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K911685 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 3 other ancestorsK911685 · Ranawat/Burstein Porous Total Hip Femoral Comp · Biomet, Inc. · 19911990199219941996199820002002
Other ancestors, by generation 1 generation back: 3 other ancestors K911685 · Ranawat/Burstein Porous Total Hip Femoral Comp · Biomet, Inc. · 19910
  1. Root · 1 generation backK911685 Ranawat/Burstein Porous Total Hip Femoral CompBiomet, Inc. · 1991
  2. This deviceK002320 Accolade C Femoral ComponentHowmedica Osteonics Corp. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911685Ranawat/Burstein Porous Total Hip Femoral CompBiomet, Inc.1991—
0 (this device)K002320Accolade C Femoral ComponentHowmedica Osteonics Corp.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199430
FIG. 1 — Lineage of K002320, 1991–2000Source: 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? (4)

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
*K936126Howmedics DRG Femoral Component
Summary page 1
…al Component is based upon equivalence in intended use, materials, design, and operational principles to the Howmedica® DRG Femoral Component (Howmedica Osteonics Corp.; K936126), Howmedica® Premium Femoral Component (Howmedica Osteonics Corp.; K936127), Osteonics® Omnifit® EON™ Hip System (Howmedica Osteo…
Howmedica, Inc.1994—
*K936127Howmedica Premium Femoral Component
Summary page 1
…and operational principles to the Howmedica® DRG Femoral Component (Howmedica Osteonics Corp.; K936126), Howmedica® Premium Femoral Component (Howmedica Osteonics Corp.; K936127), Osteonics® Omnifit® EON™ Hip System (Howmedica Osteonics Corp; K933561) and Ranawat/Burstein Total Hip Femoral Component (Biome…
Howmedica, Inc.19941
*K933561Osteonics Omnifit Forged Hip Stem Series
Summary page 1
…dica Osteonics Corp.; K936126), Howmedica® Premium Femoral Component (Howmedica Osteonics Corp.; K936127), Osteonics® Omnifit® EON™ Hip System (Howmedica Osteonics Corp; K933561) and Ranawat/Burstein Total Hip Femoral Component (Biomet®; K911 685). For information contact: Ms. Nancy J. Rieder Rutherford R…
Osteonics Corp.1994—
*K911685Ranawat/Burstein Porous Total Hip Femoral Comp
Summary page 1
…(Howmedica Osteonics Corp.; K936127), Osteonics® Omnifit® EON™ Hip System (Howmedica Osteonics Corp; K933561) and Ranawat/Burstein Total Hip Femoral Component (Biomet®; K911 685). For information contact: Ms. Nancy J. Rieder Rutherford Regulatory Affairs Howmedica Osteonics Corp. 359 Veterans Boulevard Ru…
Biomet, Inc.1991—

Also cleared against K936126: 3 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?

  • 1 of the 4 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K936126.

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?

The AccoladeTmC Femoral Component is indicated for cemented primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally, this femoral stem can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This stem is also indicated for use in revision procedures where other treatments or devices have failed.

The AccoladeTmC Femoral Component is intended for implantation with bone cement.

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 K936126

3 other devices cite the same predicate.

  • K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 200212 recalls
  • K980813Reliance Long Stem Femoral ComponentsHowmedica, Inc. · 1998
  • K970200Reliance PF Femoral StemsHowmedica Corp. · 19971 recall

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

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/K002320 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002320: Accolade C Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002320

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026