510(k) · Cleared
ClearedREDAPT¿ Revision Femoral System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 3, 2015 as substantially equivalent to K113789 (Smith & Nephew, Inc., 2012) after a 55-day review. Its family tree reaches back 7 generations to 1985. 7 later devices descend from it.
- Decided
- Sep 3, 2015
- Review
- 55 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K850055 (1985). 37 ancestors in all, the oldest K840643 (1984). 7 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 6 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 5 generations backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 4 generations backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- 3 generations backK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK081124 MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK113789 Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · Recalled
- This deviceK151902 REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK162303 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 · cites it directly · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · cites it directly · 0 of its ownK243021 Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc. · 2017 · cites it directly4descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · cites it directly0descendants
- K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd. · 2025 · cites it directly0descendants
- K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −6 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −5 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| −4 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| −3 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| −2 | K081124 | MDF Revision Hip System | Smith & Nephew, Inc. | 2008 | 2 |
| −1 | K113789 | Modular Proximally Fluted Hip Stem | Smith & Nephew, Inc. | 2012 | 1 |
| 0 (this device) | K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | 2015 | — |
| +1 | K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | 2017 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +1 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +1 | K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +2 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners… | Smith & Nephew, Inc. | 2024 | — |
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 |
|---|---|---|
| 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 |
|---|---|---|---|
| * | K113789 | Modular Proximally Fluted Hip StemSummary page 4…design to the Smith & Nephew REDAPT™ Revision Femoral System. The REDAPT Revision Femoral System currently consists of the Modular Proximally Fluted Hip Stems cleared by K113789 and the Modular Sleeved Revision Hip Stems cleared by K121627. The proposed devices are REDAPT Sleeveless Monolithic Revision Ste… | 2012 |
| † | K121627 | Smith & Nephew Redapt Revision Femoral System | 2012 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 10 of the 36 ancestors have a recall of any class.
- Of its descendants, K162303 (Smith & Nephew, Inc., 2017) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
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 osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic 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 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.
Smith & Nephew REDAPT™ 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/K151902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151902: REDAPT¿ Revision Femoral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151902
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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