510(k) · Cleared
Recalled · Class II · 2016MDF Revision Hip System
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 Jul 31, 2008 as substantially equivalent to K042127 (Smith & Nephew, Inc., 2004) and 3 other predicates after a 101-day review. Its family tree reaches back 5 generations to 1985. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 31, 2008
- Review
- 101 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K850055 (1985). 35 ancestors in all, the oldest K840643 (1984). 14 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 4 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 3 generations backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 2 generations backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- 1 generation backK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- This deviceK081124 MDF Revision Hip SystemSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK113789 Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 7 of its ownK151902 REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK121627 Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · cites it directly · 5 of its ownK100481 Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK162303 REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · cites it directly8descendants
- K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015 · 2 generations on7descendants
- K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc. · 2010 · cites it directly5descendants
- K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc. · 2017 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −4 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −3 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| −2 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| −1 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| 0 (this device) | K081124 | MDF Revision Hip System | Smith & Nephew, Inc. | 2008 | — |
| +1 | K113789 | Modular Proximally Fluted Hip Stem | Smith & Nephew, Inc. | 2012 | 1 |
| +2 | K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | 2015 | — |
| +1 | K121627 | Smith & Nephew Redapt Revision Femoral System | Smith & Nephew, Inc. | 2012 | 1 |
| +1 | K100481 | Smith & Nephew MDF Modular Sleeve | Smith & Nephew, Inc. | 2010 | — |
| +1 | K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | 2017 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K042127 | Smith & Nephew Modular HipSummary page 1…Revision Hip System is substantially equivalent to previously cleared devices listed below. Smith & Nephew, Inc. Emperion (Modular) Hip Stem K042127 11/19/2004 Smith & Nephew, Inc. MIS Hip Stem K(072417 1/10/2008 Smith &… | 2004 |
| * | K072417 | Smith & Nephew Mis Hip StemSummary page 1…ephew, Inc. Emperion (Modular) Hip Stem K042127 11/19/2004 Smith & Nephew, Inc. MIS Hip Stem K(072417 1/10/2008 Smith & Nephew, Inc. Anthology Hip Stem K052792 10/07/2005 Smith & N… | 2008 |
| * | K052792 | Anthology Hip StemSummary page 1…Nephew, Inc. MIS Hip Stem K(072417 1/10/2008 Smith & Nephew, Inc. Anthology Hip Stem K052792 10/07/2005 Smith & Nephew, Inc. Echelon Hip Stem K963486 11/27/1 996 === Pag… | 2005 |
| * | K963486 | Revision Hip SystemSummary page 1…Nephew, Inc. Anthology Hip Stem K052792 10/07/2005 Smith & Nephew, Inc. Echelon Hip Stem K963486 11/27/1 996 DEPARTMENT OF HEALTH & HUMAN SERVICES Pub… | 1996 |
What descends from it? (14)
See all 147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113789 | Modular Proximally Fluted Hip Stem | 2012 | 8 |
| K121627 | Smith & Nephew Redapt Revision Femoral System | 2012 | 5 |
| K100481 | Smith & Nephew MDF Modular Sleeve | 2010 | 5 |
| K162303 | REDAPT Sleeved Monolithic Revision Stems | 2017 | 4 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K113039 | Smith & Nephew Radiopaque Trial Necks | 2012 | 1 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip… | 2024 | 0 |
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. |
| Aug 22, 2012 | Class II | Z-2427-2012 | Employee error | Modular necks were manufactured out of specification by a vendor; the taper provide is undersized. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 8 of the 34 ancestors have a recall of any class.
- Of its descendants, K113789 (Smith & Nephew, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K042127.
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. 2008, 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?
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip…
Read the full statement (131 words)
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF 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/K081124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081124: MDF Revision Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081124
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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