510(k) · Cleared
ClearedShort Citation Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Jan 13, 2006 as substantially equivalent to K993768 (Howmedica Osteonics Corp., 2000) after a 25-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jan 13, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941141 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
- 2 generations backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
- 1 generation backK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
- This deviceK053528 Short Citation Femoral StemStryker Orthopaedics · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941141 | Precision Ostelock SP Femoral Component | Howmedica Corp. | 1994 | — |
| −2 | K972228 | Meridian Titanium Femoral Stems | Howmedica, Inc. | 1997 | — |
| −1 | K993768 | Citation TMZF HA Stem | Howmedica Osteonics Corp. | 2000 | 12 |
| 0 (this device) | K053528 | Short Citation Femoral Stem | Stryker Orthopaedics | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1996 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · 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 |
|---|---|---|---|
| * | K993768 | Citation TMZF HA StemSummary page 2…f the substantial equivalence of the Short Citation® hip stem is based on its similarities in intended use, design and sterilization to the Citation® TMZF® femoral stem (K993768, cleared January 21, 2000). Predicate device information is located in Appendix E.… | 2000 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K993768.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Revision procedures where other treatments or devices have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053528: Short Citation Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053528
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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