510(k) · Cleared
ClearedSmith & Nephew Radiopaque Trial Necks
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 Oct 5, 2012 as substantially equivalent to K080625 (Smith & Nephew, Inc., 2008) and 2 other predicates after a 359-day review. Its family tree reaches back 8 generations to 1991. 1 later device descends from it.
- Decided
- Oct 5, 2012
- Review
- 359 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K911686 (1991). 61 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 4 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
- 1 generation backK081016 Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008 · Recalled
- This deviceK113039 Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK132435 Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −4 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| −1 | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | Smith & Nephew, Inc. | 2008 | 2 |
| 0 (this device) | K113039 | Smith & Nephew Radiopaque Trial Necks | Smith & Nephew, Inc. | 2012 | — |
| +1 | K132435 | Smith & Nephew Global Femoral Head Trials | Smith & Nephew, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K080625 | Smith & Nephew Mis Hip Stem with StiktiteSummary page 1…nt metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Device Class: 11 Panel Code: Orthopaedics/87 IPH, MEH Predicate Devices: SMF Hip Stem System (K080625), MDF Revision Hip System IK081124l, Promos Reverse Shoulder System Trial Inserts (K081016) Device Description Subject of this… | 2008 |
| * | K081124 | MDF Revision Hip SystemSummary page 1…ined porous-coated uncemented prosthesis Device Class: 11 Panel Code: Orthopaedics/87 IPH, MEH Predicate Devices: SMF Hip Stem System (K080625), MDF Revision Hip System IK081124l, Promos Reverse Shoulder System Trial Inserts (K081016) Device Description Subject of this Traditional 510(k) are the Smith &N… | 2008 |
| * | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder SystemSummary page 1…1 Panel Code: Orthopaedics/87 IPH, MEH Predicate Devices: SMF Hip Stem System (K080625), MDF Revision Hip System IK081124l, Promos Reverse Shoulder System Trial Inserts (K081016) Device Description Subject of this Traditional 510(k) are the Smith &Nephew Radiopaque Trial Necks. The Radiopaque Trial Necks… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132435 | Smith & Nephew Global Femoral Head Trials | 2013 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 18 of the 60 ancestors have a recall of any class.
- Of its descendants, K132435 (Smith & Nephew, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K080625.
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. 2012, 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 (102 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; 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113039: Smith & Nephew Radiopaque Trial Necks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113039
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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