510(k) Report

510(k) · Cleared

Cleared

Osteonics Ion Implanted Femoral Bearing Series

K910988510(k) TraditionalCleared Mar 26, 199119-day reviewClass II21 CFR 888.3350

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

Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Mar 26, 1991 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 303 later devices descend from it.

Decided
Mar 26, 1991
Review
19 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
0

303 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2016: 12 descendants cleared2002: 2 descendants cleared2001: 1 descendant cleared2026: 19 descendants cleared2018: 19 descendants cleared2011: 16 descendants cleared2017: 17 descendants cleared2006: 6 descendants cleared2019: 17 descendants cleared2022: 22 descendants cleared2020: 17 descendants cleared2021: 20 descendants cleared2023: 18 descendants cleared2005: 1 descendant cleared2004: 2 descendants cleared2010: 7 descendants cleared2015: 7 descendants cleared2012: 22 descendants cleared2025: 22 descendants cleared2024: 15 descendants cleared2008: 6 descendants cleared2013: 21 descendants cleared2009: 5 descendants cleared2014: 7 descendants cleared1990200020102020
  1. This deviceK910988 Osteonics Ion Implanted Femoral Bearing SeriesOsteonics Corp. · 1991
  2. Descendant · cites it directly · 300 of its ownK010757 Lfit V40 Femoral Head ComponentsHowmedica Osteonics Corp. · 2001 · Recalled
  3. Descendant · 2 generations on · 298 of its ownK022077 36MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002 · Recalled
  4. Descendant · 3 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  5. Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  6. Descendant · 4 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004

Showing 5 of 303 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22004: 22005: 12006: 62007: 22008: 62009: 52010: 72011: 162012: 222013: 212014: 72015: 72016: 122017: 172018: 192019: 172020: 172021: 202022: 222023: 182024: 152025: 222026: 19
2001high 22 (2012) · low 0 (2003)2026

Most influential descendants

Showing 5 of 303 · See all
  • K010757Lfit V40 Femoral Head ComponentsHowmedica Osteonics Corp. · 2001 · cites it directly300descendants
  • K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002 · 2 generations on298descendants
  • K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 3 generations on267descendants
  • K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants
  • K043079Bicontact Hip System with U-CapAesculap · 2004 · 4 generations on166descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910988Osteonics Ion Implanted Femoral Bearing SeriesOsteonics Corp.1991—
+1K010757Lfit V40 Femoral Head ComponentsHowmedica Osteonics Corp.20014
+2K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp.200212
+3K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
+3K042344Excia Total Hip SystemAesculap, Inc.200510
+4K043079Bicontact Hip System with U-CapAesculap2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
200420
200510
200660
200720
200860
200950
201070
2011160
2012220
2013210
201470
201570
2016120
2017170
2018190
2019170
2020170
2021200
2022220
2023180
2024150
2025220
2026190
FIG. 1 — Lineage of K910988, 1991–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (303)

See all 303

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

NumberDeviceApplicantDecidedDescendants
K010757Lfit V40 Femoral Head ComponentsHowmedica Osteonics Corp.2001300
K063791Corin Unipolar Modular HeadCorin USA200763
K02131036MM C-Taper Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp.200255
K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics201617
K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20260

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, K010757 (Howmedica Osteonics Corp., 2001) has gone furthest, with 300 descendants of its own.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K910988 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910988: Osteonics Ion Implanted Femoral Bearing Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910988

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026