510(k) · Cleared
Recalled · Class II · 2013Enhanced Modular Austin Moore Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KMC Prosthesis, Hip, Semi-Constrained, Composite/Metal
Cleared on Apr 26, 1994 after a 127-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.
- Decided
- Apr 26, 1994
- Review
- 127 days
- Class
- Class II
- Product code
- KMC
- Recalls
- 1
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 KMC? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2013 | Class II | Z-1018-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KMC devicesKMC Prosthesis, Hip, Semi-Constrained, Composite/Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMC
FDA has decided no KMC device since 2007.
Median 510(k) review, days · KMC
Too few KMC 510(k)s in any year since 2007 to give a median.
Recalls per year · KMC
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMC
1in 2022
MAUDE reports naming product code KMC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K936044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K936044: Enhanced Modular Austin Moore Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K936044
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026