510(k) · Cleared
ClearedOsteo Austin Moore Endoprosthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Mar 16, 1998 after an 83-day review. The FDA summary names its predicate without a number. 151 later devices descend from it.
- Decided
- Mar 16, 1998
- Review
- 83 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 0
151 later devices descend from it, 2 citing it directly.
- This deviceK974807 Osteo Austin Moore Endoprosthesis SystemOsteonics Corp. · 1998
- 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 151 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 151 · 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) | K974807 | Osteo Austin Moore Endoprosthesis System | Osteonics Corp. | 1998 | — |
| +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 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 9 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 20 | 0 |
| 2020 | 14 | 0 |
| 2021 | 9 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 11 | 0 |
| 2025 | 10 | 0 |
| 2026 | 12 | 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? (1)
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 |
|---|---|---|---|
| * | — | Howmedica Austin Moore Endoprosthesis, Howmedica Inc. Named without a submission number |
What descends from it? (151)
See all 1512 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 | — |
What is it indicated for?
The subject devices are intended for hemi-hip replacement. They are intended for cemented use only.
Indications
Femoral head/neck fractures
Aseptic necrosis of the femoral head
Osteo-, rheumatoid, and post-traumatic arthitis of the hip with minimal acetabular involvement.
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/K974807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974807: Osteo Austin Moore Endoprosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974807
Report an extraction error
Are you the manufacturer?
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