510(k) · Cleared
ClearedFitmore Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Nov 5, 2019 as substantially equivalent to K071723 (Zimmer GmbH, 2008) after a 78-day review. Its family tree reaches back 6 generations to 1985. 1 later device descends from it.
- Decided
- Nov 5, 2019
- Review
- 78 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K850055 (1985). 45 ancestors in all, the oldest K845025 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 5 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 4 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 3 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 2 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 1 generation backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- This deviceK192236 Fitmore Hip StemZimmer GmbH · 2019
- Descendant · cites it directly · 0 of its ownK200112 Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K200112Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −5 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −4 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −3 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −2 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −1 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| 0 (this device) | K192236 | Fitmore Hip Stem | Zimmer GmbH | 2019 | — |
| +1 | K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · 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 |
|---|---|---|---|
| * | K071723 | Zimmer Porolock Mis StemSummary page 4…constrained cemented or nonporous uncemented prosthesis Predicate Device: Fitmore® Hip Stem, manufactured by Zimmer GmbH, K071723, cleared March 7, 2008 Device Description: The Fitmore® Hip Stem is a modular f… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200112 | Zimmer Hip Joint Replacement | 2020 | 0 |
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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 12 of the 45 ancestors have a recall of any class.
- Of its descendants, K200112 (Zimmer GmbH, 2020) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K071723.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., theumatoid arthritis.
Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.
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/K192236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192236: Fitmore Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192236
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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