510(k) · Cleared
ClearedTrimax Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 27, 1996 after a 71-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Dec 27, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964163 Trimax Nail SystemSmith & Nephew Richards, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK122170 Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964163 | Trimax Nail System | Smith & Nephew Richards, Inc. | 1996 | — |
| +1 | K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | Smith & Nephew, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | — | ZMS Intramedullary Fixation System (Zimmer) Named without a submission number | |
| * | — | Grosse & Kempf Locking Nail (Howmedica) Named without a submission number | |
| * | — | Retrograde Femoral Nail (Biomet) Named without a submission number | |
| * | — | Aim Titanium Supracondylar Nail (Ace) Named without a submission number | |
| * | — | Alta Nail (Howmedica) Named without a submission number | |
| * | — | Femoral Nail System (Synthes) Named without a submission number |
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 |
|---|---|---|---|
| K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | 2012 | 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, K122170 (Smith & Nephew, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening/shortening; femur reconstruction following tumor resection and grafting; fractures in osteoporotic bone; severely comminuted shaft fractures; pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic…
Read the full statement (119 words)
Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening/shortening; femur reconstruction following tumor resection and grafting; fractures in osteoporotic bone; severely comminuted shaft fractures; pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic nailing of impending pathologic fractures.
Additional indications for the femoral/recon antegrade include: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures.
Additional indications for retrograde nails include: severely comminuted supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. Also, fractures above total knee implants.
The TriMax Nail System is intended to be removed upon fracture healing.
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/K964163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964163: Trimax Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964163
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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