510(k) · Cleared
ClearedREDAPT Sleeved Monolithic Revision Stems
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 May 1, 2017 as substantially equivalent to K151902 (Smith & Nephew, Inc., 2015) and 6 other predicates after a 257-day review. Its family tree reaches back 8 generations to 1985. 4 later devices descend from it.
- Decided
- May 1, 2017
- Review
- 257 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K850055 (1985). 40 ancestors in all, the oldest K840643 (1984). 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 7 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 6 generations backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 5 generations backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- 4 generations backK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK081124 MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK113789 Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · Recalled
- 1 generation backK151902 REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015
- This deviceK162303 REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK231448 TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
- K242375OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024 · 2 generations on0descendants
- K231448TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −7 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −6 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| −5 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| −4 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| −3 | K081124 | MDF Revision Hip System | Smith & Nephew, Inc. | 2008 | 2 |
| −2 | K113789 | Modular Proximally Fluted Hip Stem | Smith & Nephew, Inc. | 2012 | 1 |
| −1 | K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | 2015 | — |
| 0 (this device) | K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | 2017 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners… | Smith & Nephew, Inc. | 2024 | — |
| +2 | K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024 | — |
| +2 | K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023 | 1 |
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 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K151902 | REDAPT¿ Revision Femoral SystemSummary page 4…Clearance Date Number Smith & Nephew, Inc. REDAPT Sleeveless Monolithic Stem K151902 09/03/2015 REDAPT Modular Sleeved Revision Hip Smith & Nephew, Inc.… | 2015 |
| * | K121627 | Smith & Nephew Redapt Revision Femoral SystemSummary page 4…onolithic Stem K151902 09/03/2015 REDAPT Modular Sleeved Revision Hip Smith & Nephew, Inc. K121627 10/15/2012 Stem Smith & Nephew, Inc. MDF Revision Hip System K081124 7… | 2012 |
| * | K081124 | MDF Revision Hip SystemSummary page 4…ew, Inc. K121627 10/15/2012 Stem Smith & Nephew, Inc. MDF Revision Hip System K081124 7/31/2008 Depuy Orthopaedics, K954935 01/22/1996… | 2008 |
| * | K954935 | S-Rom Femoral Hip Stem - Size 14 X 8Summary page 4…Stem Smith & Nephew, Inc. MDF Revision Hip System K081124 7/31/2008 Depuy Orthopaedics, K954935 01/22/1996 S-ROM Hip Stem Inc. K961939… | 1996 |
| * | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Summary page 4…K954935 01/22/1996 S-ROM Hip Stem Inc. K961939 08/13/1996 K042127 11/19/2004 Smith & Nephew, Inc… | 1996 |
| * | K042127 | Smith & Nephew Modular HipSummary page 4…S-ROM Hip Stem Inc. K961939 08/13/1996 K042127 11/19/2004 Smith & Nephew, Inc. Emperion Hip System K0… | 2004 |
| * | K052426 | Smith & Nephew Modular HipSummary page 4…K042127 11/19/2004 Smith & Nephew, Inc. Emperion Hip System K052426 12/07/2005 Device Description Subject of this Abbreviated premarket notification is the addition of a new stem design t… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
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 3.7 years on median.
- 11 of the 39 ancestors have a recall of any class.
- Of its descendants, K211176 (Smith & Nephew, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K151902.
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?
The REDAPT Sleeved Monolithic Revision Stems are 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 osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the…
Read the full statement (143 words)
The REDAPT Sleeved Monolithic Revision Stems are 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 osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic 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; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REDAPT™ Revision Hip System (formerly MDF) is intended to be used without cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162303: REDAPT Sleeved Monolithic Revision Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162303
Report an extraction error
Are you the manufacturer?
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