510(k) · Cleared
ClearedProfile Femoral Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Apr 23, 1985 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 387 devices in its family, counting itself, has a Class I recall. 386 later devices descend from it.
- Decided
- Apr 23, 1985
- Review
- 105 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 0
386 later devices descend from it, 2 citing it directly. 1 of the 387 devices in this family, counting this one, has a Class I recall.
- This deviceK850055 Profile Femoral HipDepuy, Inc. · 1985
- Descendant · cites it directly · 384 of its ownK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 363 of its ownK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- Descendant · 3 generations on · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- Descendant · 4 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · 5 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
Showing 5 of 386 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…5 generations on · 2007
Most influential descendants
Showing 5 of 386 · See all- K961378Delta Hip ProsthesisZimmer, Inc. · 1996 · cites it directly384descendants
- K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997 · 2 generations on363descendants
- K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · 3 generations on296descendants
- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 4 generations on267descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 5 generations on198descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| +1 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| +2 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| +3 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| +4 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +5 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 1 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 17 | 0 |
| 2012 | 29 | 0 |
| 2013 | 26 | 0 |
| 2014 | 13 | 0 |
| 2015 | 13 | 0 |
| 2016 | 16 | 0 |
| 2017 | 23 | 0 |
| 2018 | 22 | 0 |
| 2019 | 24 | 0 |
| 2020 | 25 | 0 |
| 2021 | 20 | 0 |
| 2022 | 20 | 0 |
| 2023 | 20 | 0 |
| 2024 | 19 | 0 |
| 2025 | 25 | 0 |
| 2026 | 23 | 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.
1 device in this family has a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (386)
See all 3862 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K961378 (Zimmer, Inc., 1996) has gone furthest, with 384 descendants of its own.
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 | — |
https://510kreport.com/device/K850055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K850055: Profile Femoral Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850055
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026