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 Feb 7, 2017 as substantially equivalent to K071723 (Zimmer GmbH, 2008) after a 29-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Feb 7, 2017
- Review
- 29 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). No later device cites it as a predicate yet.
- 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 deviceK170072 Fitmore® Hip StemZimmer GmbH · 2017
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) | K170072 | Fitmore® Hip Stem | Zimmer GmbH | 2017 | — |
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 |
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 3…Indications for Use See PRA Statement below. 510(k) Number (if known) Not yet known (submitted as a Special 510(k) to K071723) K170072 Device Name Fitmore® Hip Stem Indications for Use (Describe) This femoral stem is for total hip or hemi-hip art… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 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.
- 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. 2017, 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: • Non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. • Failed previous surgery where pain, deformity, or dysfunction persists. • Revision of previously failed hip arthroplasty. • Total hip replacements may be considered for younger patients…
Read the full statement (124 words)
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
• Non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• 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.
This stem is for uncemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170072: 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/K170072
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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