510(k) · Cleared
Recalled · Class II · 2016Smith & Nephew Mis Hip Stem with Stiktite
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 May 8, 2008 as substantially equivalent to K072417 (Smith & Nephew, Inc., 2008) after a 64-day review. Its family tree reaches back 5 generations to 1985. 19 later devices descend from it. It has been recalled once.
- Decided
- May 8, 2008
- Review
- 64 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K850055 (1985). 21 ancestors in all, the oldest K840643 (1984). 19 later devices descend from it, 4 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 deviceK080625 Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 16 of its ownK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 10 of its ownK123012 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
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · cites it directly16descendants
- K123012Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2012 · 2 generations on10descendants
- 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
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) | K080625 | Smith & Nephew Mis Hip Stem with Stiktite | Smith & Nephew, Inc. | 2008 | — |
| +1 | K103256 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2011 | 2 |
| +2 | 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 |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 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 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 24.3 · 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 |
|---|---|---|---|
| * | K072417 | Smith & Nephew Mis Hip StemSummary page 1…DAE Smith & Nephew, Inc. MIS Hip Stem K072417 1/10/2008 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health… | 2008 |
What descends from it? (19)
See all 194 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2016 | Class II | Z-0946-2017 | 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 23 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 8 of the 20 ancestors have a recall of any class.
- Of its descendants, K103256 (Smith & Nephew, Inc., 2011) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K072417.
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. 2008, 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?
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 osteoarthdtis; 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 osteoarthdtis; 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 MIS 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/K080625 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080625: Smith & Nephew Mis Hip Stem with Stiktite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080625
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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