510(k) · Cleared
ClearedSmith & Nephew SMF Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 24, 2012 as substantially equivalent to K103256 (Smith & Nephew, Inc., 2011) after a 26-day review. Its family tree reaches back 7 generations to 1985. 10 later devices descend from it.
- Decided
- Oct 24, 2012
- Review
- 26 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K850055 (1985). 23 ancestors in all, the oldest K840643 (1984). 10 later devices descend from it, 2 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 backK080625 Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled
- This deviceK123012 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK162775 Legion Cone SystemSmith & Nephew, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 4 of its ownK180334 LEGION Knee SystemSmith & Nephew, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K162775Legion Cone SystemSmith & Nephew, Inc. · 2017 · cites it directly5descendants
- K180334LEGION Knee SystemSmith & Nephew, Inc. · 2018 · 2 generations on4descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 2 generations on3descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 3 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 | K080625 | Smith & Nephew Mis Hip Stem with Stiktite | Smith & Nephew, Inc. | 2008 | 1 |
| −1 | K103256 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2011 | 2 |
| 0 (this device) | K123012 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2012 | — |
| +1 | K162775 | Legion Cone System | Smith & Nephew, Inc. | 2017 | 2 |
| +2 | K180334 | LEGION Knee System | Smith & Nephew, Inc. | 2018 | — |
| +2 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +3 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 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 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K103256 | Smith & Nephew SMF Hip StemSummary page 2…e, sterilization, and overall design of the Smith &Nephew SMP Hip Stem line additions are substantially equivalent to the SMF0 Hip Stems cleared inpremarket notification K103256. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the o… | 2011 |
What descends from it? (10)
2 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 27 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 10 of the 22 ancestors have a recall of any class.
- Of its descendants, K162775 (Smith & Nephew, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K103256.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
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 (NIDJO) 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 (139 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 (NIDJO) 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 SMF Hip Stem 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/K123012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123012: Smith & Nephew SMF 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/K123012
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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