510(k) Report

510(k) · Cleared

Cleared

Stelkast 32MM Modular Ceramic Femoral Head

K033944510(k) TraditionalCleared Mar 12, 200484-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

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

Cleared on Mar 12, 2004 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.

Decided
Mar 12, 2004
Review
84 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2014: 2 descendants cleared2022: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK033944 Stelkast 32MM Modular Ceramic Femoral HeadStelkast Company · 2004
  2. Descendant · cites it directly · 6 of its ownK132158 Novohip Total Hip SystemNovosource, Inc. · 2014 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK143314 Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2015
  4. Descendant · 2 generations on · 2 of its ownK140701 Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014
  5. Descendant · 2 generations on · 1 of its ownK213842 ONVOY Acetabular SystemGlobus Medical, Inc. · 2022
  6. Descendant · 3 generations on · 1 of its ownK151424 The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2010: 12014: 22015: 12016: 12019: 12022: 12025: 1
2010high 2 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 8 · See all
  • K132158Novohip Total Hip SystemNovosource, Inc. · 2014 · cites it directly6descendants
  • K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2015 · 2 generations on2descendants
  • K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014 · 2 generations on2descendants
  • K213842ONVOY Acetabular SystemGlobus Medical, Inc. · 2022 · 2 generations on1descendant
  • K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2016 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033944Stelkast 32MM Modular Ceramic Femoral HeadStelkast Company2004—
+1K132158Novohip Total Hip SystemNovosource, Inc.20141
+2K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC2015—
+2K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.2014—
+2K213842ONVOY Acetabular SystemGlobus Medical, Inc.2022—
+3K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201420
201510
201610
201910
202210
202510
FIG. 1 — Lineage of K033944, 2004–2025Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K132158Novohip Total Hip SystemNovosource, Inc.20146
K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100

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?

  • Of its descendants, K132158 (Novosource, Inc., 2014) has gone furthest, with 6 descendants of its own.

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 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.

Indications for use as stated in the FDA 510(k) statement.

More from Stelkast Company

43 FDA decisions under this applicant name. See the company

  • K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company · 20131 recall
  • K122773Cross-Over Acetabular Shell & LinerStelkast Company · 20121 recall
  • P040051/S002Stelkast Surpass Acetabular SystemStelkast Company · 2011
  • K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company · 2011
  • P040051/S001Stelkast Surpass Acetabular SystemStelkast Company · 2009

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/K033944 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033944: Stelkast 32MM Modular Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033944

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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