510(k) · Cleared
ClearedAustin-Moore Modular Hip Prosthesis
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 Apr 19, 1985 after a 113-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 118 later devices descend from it.
- Decided
- Apr 19, 1985
- Review
- 113 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 0
118 later devices descend from it, 1 citing it directly.
- This deviceK845025 Austin-Moore Modular Hip ProsthesisBiomet, Inc. · 1985
- Descendant · cites it directly · 117 of its ownK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
- Descendant · 2 generations on · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
- Descendant · 3 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
- Descendant · 4 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- Descendant · 5 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K984028The New Bio-Moore Endo HeadsBiomet, Inc. · 1999 · cites it directly117descendants
- K042037M2A Magnum SystemBiomet, Inc. · 2004 · 2 generations on116descendants
- K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 3 generations on74descendants
- K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 4 generations on73descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · 5 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K845025 | Austin-Moore Modular Hip Prosthesis | Biomet, Inc. | 1985 | — |
| +1 | K984028 | The New Bio-Moore Endo Heads | Biomet, Inc. | 1999 | — |
| +2 | K042037 | M2A Magnum System | Biomet, Inc. | 2004 | — |
| +3 | K053536 | Durom Acetabular Component and Metasul LDH Large Diameter Heads | Zimmer GmbH | 2006 | 13 |
| +4 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| +5 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (118)
See all 1181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984028 | The New Bio-Moore Endo Heads | 1999 | 117 |
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, K984028 (Biomet, Inc., 1999) has gone furthest, with 117 descendants of its own.
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 | — |
https://510kreport.com/device/K845025 · printed Nov 4, 2026
Cite this page
510(k) Report. “K845025: Austin-Moore Modular Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K845025
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026