510(k) · Cleared
ClearedOsteonics Extended Femoral Bearing Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Oct 21, 1998 after a 61-day review. The FDA summary names its predicate without a number. 56 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 61 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 1 citing it directly.
- This deviceK982936 Osteonics Extended Femoral Bearing HeadOsteonics Corp. · 1998
- Descendant · cites it directly · 55 of its ownK021310 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002
- Descendant · 2 generations on · 54 of its ownK061434 Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · Recalled
- Descendant · 3 generations on · 37 of its ownK110290 Exeter Hip StemHowmedica Osteonics Corp. · 2011 · Recalled
- Descendant · 2 generations on · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 3 generations on · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K02131036MM C-Taper Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. · 2002 · cites it directly55descendants
- K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · 2 generations on54descendants
- K110290Exeter Hip StemHowmedica Osteonics Corp. · 2011 · 3 generations on37descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · 2 generations on17descendants
- K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982936 | Osteonics Extended Femoral Bearing Head | Osteonics Corp. | 1998 | — |
| +1 | K021310 | 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit) | Howmedica Osteonics Corp. | 2002 | — |
| +2 | K061434 | Trident Large Diameter Hip System | Howmedica Osteonics Corp. | 2006 | 2 |
| +3 | K110290 | Exeter Hip Stem | Howmedica Osteonics Corp. | 2011 | 1 |
| +2 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +3 | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Osteonics® Morse Taper Heads Named without a submission number | |
| * | — | Osteonics® C-Taper Heads Named without a submission number | |
| * | — | DePuy Articule-Eze® Total Hip Balls Named without a submission number |
What descends from it? (56)
See all 561 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021310 | 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit) | 2002 | 55 |
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, K021310 (Howmedica Osteonics Corp., 2002) has gone furthest, with 55 descendants of its own.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Osteonics® Extended Femoral Bearing Heads are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® Extended Femoral Bearing Heads are designed to accommodate a patient population requiring extended offset provided by a plus 12.5mm or a plus 15mm femoral head option when used in conjunction with the Osteonics® Femoral Stems specified in this submission. Indications: For use as…
Read the full statement (203 words)
The Osteonics® Extended Femoral Bearing Heads are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® Extended Femoral Bearing Heads are designed to accommodate a patient population requiring extended offset provided by a plus 12.5mm or a plus 15mm femoral head option when used in conjunction with the Osteonics® Femoral Stems specified in this submission.
Indications:
For use as a Bipolar or Hemi-Hip R;bglacement:
® Femoral head/neck fractures or non-unions.
® Aseptic necrosis of the femoral head.
® Osteo-, theumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other considerations for use as a Bipolar or Hemi-Hip Replacement:
e Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
® Salvage of failed total hip arthroplasty.
For use as a Total Hip Replacement:
e Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular Necrosis.
® Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
® Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982936 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982936: Osteonics Extended Femoral Bearing Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982936
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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