510(k) Report

510(k) · Cleared

Cleared

Implex Ceramic Head

K955117510(k) TraditionalCleared Apr 5, 1996148-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

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

Cleared on Apr 5, 1996 as substantially equivalent to K925345 (Biomet, Inc., 1994) and 2 other predicates after a 148-day review. Its family tree reaches back 1 generation to 1994.

Decided
Apr 5, 1996
Review
148 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K925345 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestorsK925345 · Ziconia Ceramic Mod Head (Type I Taper 28/32, +6MM) · Biomet, Inc. · 199419901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors K925345 · Ziconia Ceramic Mod Head (Type I Taper 28/32, +6MM) · Biomet, Inc. · 19940
  1. Root · 1 generation backK925345 Ziconia Ceramic Mod Head (Type I Taper 28/32, +6MM)Biomet, Inc. · 1994
  2. This deviceK955117 Implex Ceramic HeadImplex Corp. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K925345Ziconia Ceramic Mod Head (Type I Taper 28/32, +6MM)Biomet, Inc.1994—
0 (this device)K955117Implex Ceramic HeadImplex Corp.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
FIG. 1 — Lineage of K955117, 1994–1996Source: 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? (5)

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
*K925345Ziconia Ceramic Mod Head (Type I Taper 28/32, +6MM)
Summary page 1
…ent Products: PROZYR™ Zirconium Oxide Ceramic Head from Smith & Nephew Richards, Inc. Ceramic Bearing Head from Osteonics, Corp. Modular Ceramic Heads from Biomet. Inc. (K925345) Zr Ceramic Heads from Howmedica (K952418 & K946026) Description: The Implex Ceramic Head is a ceramic femoral head. It is a sph…
Biomet, Inc.1994—
*K952418V40 Zirconia Femoral Heads
Summary page 1
…mic Head from Smith & Nephew Richards, Inc. Ceramic Bearing Head from Osteonics, Corp. Modular Ceramic Heads from Biomet. Inc. (K925345) Zr Ceramic Heads from Howmedica (K952418 & K946026) Description: The Implex Ceramic Head is a ceramic femoral head. It is a spherical ball made from zirconia ceramic whi…
Howmedica Corp.1995—
*K946026Howmedica (R) 28MM Zirconia Femoral Heads
Summary page 1
…rom Smith & Nephew Richards, Inc. Ceramic Bearing Head from Osteonics, Corp. Modular Ceramic Heads from Biomet. Inc. (K925345) Zr Ceramic Heads from Howmedica (K952418 & K946026) Description: The Implex Ceramic Head is a ceramic femoral head. It is a spherical ball made from zirconia ceramic which has a t…
Howmedica, Inc.1995—
*—PROZYR™ Zirconium Oxide Ceramic Head from Smith & Nephew Richards, Inc.
Named without a submission number
—
*—Ceramic Bearing Head from Osteonics, Corp.
Named without a submission number
—

Also cleared against K925345: 1 other device →

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?

  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K925345.

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 Implex Ceramic Head is intended to provide articulation in cases of: Severely disabled joints as a result of degenerative arthritis or avascular NECrosis. Secondary revision of a previously unsuccessful femoral component or total hip replacement. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results. Fracture dislocation of the hip or irreducible fractures in which…

Read the full statement (117 words)

The Implex Ceramic Head is intended to provide articulation in cases of:

Severely disabled joints as a result of degenerative arthritis or avascular NECrosis.

Secondary revision of a previously unsuccessful femoral component or total hip replacement.

Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.

Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.

Non-union of femoral neck or head fractures.

Salvage of a failed primary or secondary total or hemi hip.

The Implex Ceramic Head is intended to be used in either cemented or uncemented applications depending on the intended use of the femoral stem it is mated with.

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 K925345

1 other device cites the same predicate.

  • K042091Biolox Delta Ceramic HeadsBiomet, Inc. · 20052 recalls

More from Implex Corp.

65 FDA decisions under this applicant name. See the company

  • K051978Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
  • K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp. · 2005
  • K040487Trabecular Metal Knee System AugmentsImplex Corp. · 20041 recall
  • K040630Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZImplex Corp. · 20042 recalls
  • K040756The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004

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/K955117 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955117: Implex Ceramic Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955117

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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