510(k) · Cleared
Recalled · Class II · 2012Durom Acetabular Component and Metasul LDH Large Diameter Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Mar 16, 2006 as substantially equivalent to K042037 (Biomet, Inc., 2004) and 2 other predicates after an 87-day review. Its family tree reaches back 4 generations to 1988. 74 later devices descend from it. It has been recalled 13 times.
- Decided
- Mar 16, 2006
- Review
- 87 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 13
- Predicates
- 3
Its longest line of descent runs back 4 generations to K881288 (1988). 24 ancestors in all, the oldest K845025 (1985). 74 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
- 3 generations backK960538 Opteon UnipolarExactech, Inc. · 1996
- 2 generations backK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
- 1 generation backK042037 M2A Magnum SystemBiomet, Inc. · 2004
- This deviceK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006
- Descendant · cites it directly · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- Descendant · 2 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- Descendant · 2 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- Descendant · 2 generations on · 19 of its ownK130899 Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013
- Descendant · 3 generations on · 14 of its ownK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · cites it directly73descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · 2 generations on41descendants
- K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 2 generations on34descendants
- K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013 · 2 generations on19descendants
- K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881288 | Corin Modular Moore Stem | Orthopedic Systems, Inc. | 1988 | — |
| −3 | K960538 | Opteon Unipolar | Exactech, Inc. | 1996 | — |
| −2 | K984028 | The New Bio-Moore Endo Heads | Biomet, Inc. | 1999 | — |
| −1 | K042037 | M2A Magnum System | Biomet, Inc. | 2004 | — |
| 0 (this device) | K053536 | Durom Acetabular Component and Metasul LDH Large Diameter Heads | Zimmer GmbH | 2006 | — |
| +1 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| +2 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| +2 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| +2 | K130899 | Biolox Delta Ceramic Femoral Heads | Zimmer GmbH | 2013 | — |
| +3 | K120030 | Taperloc Complete Size 4MM and XR 123 | Biomet Manufacturing Corp | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 9 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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 KWA? 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 |
|---|---|---|---|
| * | K042037 | M2A Magnum SystemSummary page 1…acetabular component, prosthesis Classification Reference 21 CTR § 888.3330 Predicate Devices · Biomet M 2A Magnum System (K042037) * Wright Metal Transcend Articular System (K021349)… | 2004 |
| * | K021349 | Metal Transcend Articulation System (Larger Sizes)Summary page 1…0 Predicate Devices · Biomet M 2A Magnum System (K042037) * Wright Metal Transcend Articular System (K021349) - Centerpulse/Zimmer EpsilonTrlm Metasul®Acetabular insert… | 2002 |
| * | K033634 | Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedSummary page 1…- Centerpulse/Zimmer EpsilonTrlm Metasul®Acetabular insert and Metasul Modular Femoral head (K033634) Device Description The Metasul LDII large d iameter h cad system consists o f Iarge… | 2004 |
What descends from it? (74)
See all 741 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071723 | Zimmer Porolock Mis Stem | 2008 | 73 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0248-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Jul 22, 2008 | Not classified | Z-2426-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2417-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2419-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2421-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2422-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2415-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2424-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2420-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2423-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2416-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2418-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
| Jul 22, 2008 | Not classified | Z-2425-2008 | Labeling False and Misleading | Instructions for use/surgical technique instructions are inadequate. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K071723 (Zimmer GmbH, 2008) has gone furthest, with 73 descendants of its own.
- 7 other devices also cite its predicate K042037.
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
MAUDE reports naming product code KWA, 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 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
* Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. * Those patients with failed previous surgery where pain, deformity, or dysfunction persists. * Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with…
Read the full statement (105 words)
* Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
* Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
* Revision of previously failed hip arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053536: Durom Acetabular Component and Metasul LDH Large Diameter Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053536
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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