510(k) · Cleared
ClearedEntrada™ hip stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corporation · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Aug 24, 2017 as substantially equivalent to K953111 (Landos, Inc., 1996) and 6 other predicates after a 118-day review. Its family tree reaches back 14 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 24, 2017
- Review
- 118 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K941847 (1994). 264 ancestors in all, the oldest K810258 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations between
- 3 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 2 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 1 generation backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- This deviceK171249 Entrada™ hip stemOrtho Development Corporation · 2017
- Descendant · cites it directly · 1 of its ownK233758 Trivicta™ Hip StemOrtho Development Corp. · 2024
- Descendant · 2 generations on · 0 of its ownK251052 Trivicta® Hip StemOrtho Development Corp. · 2025
Show all 14 generations
- Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 12 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 11 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 10 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 9 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 8 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 7 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 6 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 5 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 4 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 3 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 2 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 1 generation backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- This deviceK171249 Entrada™ hip stemOrtho Development Corporation · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −13 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −12 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −11 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −10 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −9 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −8 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −7 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −6 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −5 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −4 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −3 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −2 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −1 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| 0 (this device) | K171249 | Entrada™ hip stem | Ortho Development Corporation | 2017 | — |
| +1 | K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024 | — |
| +2 | K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 6 | 0 |
| 1994 | 27 | 0 |
| 1995 | 15 | 0 |
| 1996 | 19 | 0 |
| 1997 | 13 | 0 |
| 1998 | 10 | 0 |
| 1999 | 13 | 0 |
| 2000 | 28 | 0 |
| 2001 | 14 | 0 |
| 2002 | 14 | 0 |
| 2003 | 12 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | K953111 | CorailSummary page 4…hesis Device Product Code: MEH, LZO, KWY, KWL Class: Class II Primary Predicate Device: Depuy Synthes Corail Hip Stem (K953111, K093736, K042992, K070554, K123991) Secondary Predicate Ortho Development® Ovat… | 1996 |
| * | K093736 | Depuy Corail Hip System, Revision StemSummary page 4…vice Product Code: MEH, LZO, KWY, KWL Class: Class II Primary Predicate Device: Depuy Synthes Corail Hip Stem (K953111, K093736, K042992, K070554, K123991) Secondary Predicate Ortho Development® Ovation Tribu… | 2011 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 4…uct Code: MEH, LZO, KWY, KWL Class: Class II Primary Predicate Device: Depuy Synthes Corail Hip Stem (K953111, K093736, K042992, K070554, K123991) Secondary Predicate Ortho Development® Ovation Tribute (K1333… | 2005 |
| * | K070554 | Depuy Corail Amt Dysplasia Hip ProsthesisSummary page 4…Class: Class II Primary Predicate Device: Depuy Synthes Corail Hip Stem (K953111, K093736, K042992, K070554, K123991) Secondary Predicate Ortho Development® Ovation Tribute (K133386) Device(s): Exact… | 2007 |
| * | K123991 | Depuy Corail Amt Hip ProsthesisSummary page 4…Class II Primary Predicate Device: Depuy Synthes Corail Hip Stem (K953111, K093736, K042992, K070554, K123991) Secondary Predicate Ortho Development® Ovation Tribute (K133386) Device(s): Exactech Novat… | 2013 |
| * | K133386 | Ovation Tribute Hip Stem; Ovation Narrow Hip StemSummary page 4…es Corail Hip Stem (K953111, K093736, K042992, K070554, K123991) Secondary Predicate Ortho Development® Ovation Tribute (K133386) Device(s): Exactech Novation Element (K153649) Description: Entrada™ hip stem is a single-piece, tapere… | 2014 |
| * | K153649 | Exactech® Novation® Element Press-fit Femoral StemSummary page 4…K070554, K123991) Secondary Predicate Ortho Development® Ovation Tribute (K133386) Device(s): Exactech Novation Element (K153649) Description: Entrada™ hip stem is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) coated femoral hip s… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233758 | Trivicta™ Hip Stem | 2024 | 1 |
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 23 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 62 of the 263 ancestors have a recall of any class.
- Of its descendants, K233758 (Ortho Development Corp., 2024) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K953111.
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. 2017, this device’s year, is highlighted.
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?
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171249: Entrada™ 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/K171249
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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