510(k) · Cleared
ClearedThe New Bio-Moore Endo Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Jan 19, 1999 as substantially equivalent to K954077 (Howmedica Corp., 1995) and 5 other predicates after a 68-day review. Its family tree reaches back 2 generations to 1988. 117 later devices descend from it.
- Decided
- Jan 19, 1999
- Review
- 68 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K881288 (1988). 8 ancestors in all, the oldest K845025 (1985). 117 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
- 1 generation backK960538 Opteon UnipolarExactech, Inc. · 1996
- This deviceK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
- Descendant · cites it directly · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
- Descendant · 2 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
- Descendant · 3 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- Descendant · 4 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- Descendant · 4 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K042037M2A Magnum SystemBiomet, Inc. · 2004 · cites it directly116descendants
- K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 2 generations on74descendants
- K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 3 generations on73descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · 4 generations on41descendants
- K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 4 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881288 | Corin Modular Moore Stem | Orthopedic Systems, Inc. | 1988 | — |
| −1 | K960538 | Opteon Unipolar | Exactech, Inc. | 1996 | — |
| 0 (this device) | K984028 | The New Bio-Moore Endo Heads | Biomet, Inc. | 1999 | — |
| +1 | K042037 | M2A Magnum System | Biomet, Inc. | 2004 | — |
| +2 | K053536 | Durom Acetabular Component and Metasul LDH Large Diameter Heads | Zimmer GmbH | 2006 | 13 |
| +3 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| +4 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| +4 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 12 | 0 |
| 2021 | 8 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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 KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K954077 | Unitrax V40 Modular AdaptorSummary page 2…ilar to all other devices on the market in terms of intended use and design. Predicate devices include: Unitrax V40 Modular Adaptor (Howmedica, Rutherford, NJ) 510(K) #K954077 Osteo Austin Moore Endoprostheis System (Osteonics , Allendale, NJ) 510(K) #K974807 Prime Modular Endo Head (Orthopaedic Innovat… | 1995 |
| * | K974807 | Osteo Austin Moore Endoprosthesis SystemSummary page 2…te devices include: Unitrax V40 Modular Adaptor (Howmedica, Rutherford, NJ) 510(K) #K954077 Osteo Austin Moore Endoprostheis System (Osteonics , Allendale, NJ) 510(K) #K974807 Prime Modular Endo Head (Orthopaedic Innovations, Minneapolis, MN) 510(K) #K962646 Opteon Unipolar Endoprosthesis (Exactech, Gai… | 1998 |
| * | K962646 | Prime Modular Endo HeadSummary page 2…#K954077 Osteo Austin Moore Endoprostheis System (Osteonics , Allendale, NJ) 510(K) #K974807 Prime Modular Endo Head (Orthopaedic Innovations, Minneapolis, MN) 510(K) #K962646 Opteon Unipolar Endoprosthesis (Exactech, Gainesville, FL) 510(K) #K960538 Ultima Unipolar head and Adapter Sleeves (Johnson & J… | 1996 |
| * | K960538 | Opteon UnipolarSummary page 2…) 510(K) #K974807 Prime Modular Endo Head (Orthopaedic Innovations, Minneapolis, MN) 510(K) #K962646 Opteon Unipolar Endoprosthesis (Exactech, Gainesville, FL) 510(K) #K960538 Ultima Unipolar head and Adapter Sleeves (Johnson & Johnson, Raynham, MA) 510(K) #K965156 Austin Moore Endoprosthesis (Biomet,… | 1996 |
| * | K965156 | Ultima*Unipolar Head and Adapter SleevesSummary page 2…#K962646 Opteon Unipolar Endoprosthesis (Exactech, Gainesville, FL) 510(K) #K960538 Ultima Unipolar head and Adapter Sleeves (Johnson & Johnson, Raynham, MA) 510(K) #K965156 Austin Moore Endoprosthesis (Biomet, Warsaw, IN) 510(K) #K845025 ooess 00055 *’, ul'lq,w(' i ‘, - . - - _,/C D… | 1997 |
| * | K845025 | Austin-Moore Modular Hip ProsthesisSummary page 2…FL) 510(K) #K960538 Ultima Unipolar head and Adapter Sleeves (Johnson & Johnson, Raynham, MA) 510(K) #K965156 Austin Moore Endoprosthesis (Biomet, Warsaw, IN) 510(K) #K845025 ooess 00055 *’, ul'lq,w(' i ‘, - . - - _,/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service "h Foo… | 1985 |
What descends from it? (117)
See all 1171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042037 | M2A Magnum System | 2004 | 116 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K042037 (Biomet, Inc., 2004) has gone furthest, with 116 descendants of its own.
- 1 other device also cites its predicate K954077.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
a.) non-inflammatory degenerative joint disease, including avascular necrosis and
osteoarthritis.
b.) rheumatoid arthritis
c.) correction of functional deformities
d.) revision procedures where other devices or treatments have failed
e.) treatment of non-unions, femoral neck trochanteric fractures of the proximal femur
with neck involvement
The New Bio-Moore Endo Heads are intended for impaction on either a press-fit or
cemented femoral component and are for single use implants.
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/K984028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984028: The New Bio-Moore Endo Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984028
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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