510(k) · Cleared
Recalled · Class II · 2016Modular Proximally Fluted Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Apr 19, 2012 as substantially equivalent to K081124 (Smith & Nephew, Inc., 2008) after a 119-day review. Its family tree reaches back 6 generations to 1985. 8 later devices descend from it. It has been recalled once.
- Decided
- Apr 19, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K850055 (1985). 36 ancestors in all, the oldest K840643 (1984). 8 later devices descend 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 backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 3 generations backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- 2 generations backK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK081124 MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · Recalled
- This deviceK113789 Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK151902 REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK162303 REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · 2 generations on · 0 of its ownK243021 Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015 · cites it directly7descendants
- K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc. · 2017 · 2 generations on4descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · 2 generations on3descendants
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
- K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd. · 2025 · 2 generations on0descendants
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 | 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 |
| −2 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| −1 | K081124 | MDF Revision Hip System | Smith & Nephew, Inc. | 2008 | 2 |
| 0 (this device) | K113789 | Modular Proximally Fluted Hip Stem | Smith & Nephew, Inc. | 2012 | — |
| +1 | K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | 2015 | — |
| +2 | K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | 2017 | — |
| +2 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +2 | K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K081124 | MDF Revision Hip SystemSummary page 1…premarket notification isthe Modular Proximally Fluted Hip Stem. The subject device is a line addition to the MOP Revision Hip System cleared via premarket notification K081124. The Modular Proximally Fluted Hip Stem is astraight, tapered, distally fixed stem with amodular female 12/14 neck taper. The sub… | 2008 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151902 | REDAPT¿ Revision Femoral System | 2015 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2016 | Class II | Z-0945-2017 | Device Design | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 9 of the 35 ancestors have a recall of any class.
- Of its descendants, K151902 (Smith & Nephew, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K081124.
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. 2012, 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?
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthrilis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diasirophic variant- Hip components are also indicated for…
Read the full statement (140 words)
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthrilis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diasirophic variant-
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endloprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113789: Modular Proximally Fluted 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/K113789
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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