510(k) · Cleared
ClearedGlobal Taper Tapered Hip System, GT Spectron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jan 27, 1997 after a 146-day review. The FDA summary names no predicate by number. 44 later devices descend from it.
- Decided
- Jan 27, 1997
- Review
- 146 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 11 citing it directly.
- This deviceK963509 Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
- Descendant · cites it directly · 17 of its ownK042127 Smith & Nephew Modular HipSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 16 of its ownK061066 Synergy Hip SystemSmith & Nephew, Inc. · 2006
- Descendant · 2 generations on · 14 of its ownK081124 MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 13 of its ownK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011 · Recalled
- Descendant · 3 generations on · 8 of its ownK113789 Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K042127Smith & Nephew Modular HipSmith & Nephew, Inc. · 2004 · cites it directly17descendants
- K061066Synergy Hip SystemSmith & Nephew, Inc. · 2006 · cites it directly16descendants
- K081124MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · 2 generations on14descendants
- K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · 2 generations on13descendants
- K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963509 | Global Taper Tapered Hip System, GT Spectron | Smith & Nephew Richards, Inc. | 1997 | — |
| +1 | K042127 | Smith & Nephew Modular Hip | Smith & Nephew, Inc. | 2004 | — |
| +1 | K061066 | Synergy Hip System | Smith & Nephew, Inc. | 2006 | — |
| +2 | K081124 | MDF Revision Hip System | Smith & Nephew, Inc. | 2008 | 2 |
| +2 | K111546 | U2 Hip System | United Orthopedic Corp. | 2011 | 1 |
| +3 | K113789 | Modular Proximally Fluted Hip Stem | Smith & Nephew, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (44)
See all 4411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042127 | Smith & Nephew Modular Hip | 2004 | 17 |
| K061066 | Synergy Hip System | 2006 | 16 |
| K072817 | Echelon Titanium Hip System | 2008 | 6 |
| K052426 | Smith & Nephew Modular Hip | 2005 | 6 |
| K141001 | Alpine Hip Stem; Alpine HA Hip Stem | 2014 | 4 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K053246 | Patient Matched Hip Stem | 2006 | 1 |
| K052275 | Smith & Nephew Platform Hip Stem | 2005 | 1 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip… | 2024 | 0 |
| K141370 | Renovis Cemented Hip System | 2014 | 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?
- Of its descendants, K042127 (Smith & Nephew, Inc., 2004) has gone furthest, with 17 descendants of its own.
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.
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?
The hip stem components of the GT Tapered Hip System are made of metal alloys. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for 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…
Read the full statement (143 words)
The hip stem components of the GT Tapered Hip System are made of metal alloys. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for 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.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963509: Global Taper Tapered Hip System, GT Spectron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963509
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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