510(k) · Cleared
Recalled · Class II · 2025Sureshot Tan Nails and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Apr 26, 2010 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 5 other predicates after a 230-day review. Its family tree reaches back 4 generations to 1998. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 26, 2010
- Review
- 230 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 4 generations to K981529 (1998). 16 ancestors in all, the oldest K951740 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
- 3 generations backK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
- 2 generations backK040656 Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc. · 2004
- 1 generation backK050226 Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc. · 2005
- This deviceK092748 Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK243364 TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK243608 TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK123948 China Nails and AccessoriesSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK122170 Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc. · 2024 · cites it directly1descendant
- K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025 · 2 generations on0descendants
- K123948China Nails and AccessoriesSmith & Nephew, Inc. · 2013 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −4 | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | Smith & Nephew, Inc. | 1998 | 2 |
| −3 | K040212 | Trigen Intertan | Smith & Nephew, Inc. | 2004 | 6 |
| −2 | K040656 | Modification to Smith & Nephew Intramedullary Hip Screw | Smith & Nephew, Inc. | 2004 | — |
| −1 | K050226 | Asian Intramedullary Hip Screw Nails | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K092748 | Sureshot Tan Nails and Accessories | Smith & Nephew, Inc. | 2010 | — |
| +1 | K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. | 2024 | — |
| +2 | K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025 | — |
| +1 | K123948 | China Nails and Accessories | Smith & Nephew, Inc. | 2013 | — |
| +1 | K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | Smith & Nephew, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K981529 | Titanium Intramedullary Nail, Titanium Locking ScrewSummary page 1…AN Nails and Accessories are very similar to legally marketed devices listed below in that they share very similar indications for use (compared to devices cleared under K981529, K040212, K040462, K061019, K050226 and K010801), are manufactured from identical material, and incorporate very similar technolo… | 1998 |
| * | K040212 | Trigen IntertanSummary page 1…and Accessories are very similar to legally marketed devices listed below in that they share very similar indications for use (compared to devices cleared under K981529, K040212, K040462, K061019, K050226 and K010801), are manufactured from identical material, and incorporate very similar technological des… | 2004 |
| * | K040462 | Trigen Trochanteric Antegrade NailSummary page 1…sories are very similar to legally marketed devices listed below in that they share very similar indications for use (compared to devices cleared under K981529, K040212, K040462, K061019, K050226 and K010801), are manufactured from identical material, and incorporate very similar technological design chara… | 2004 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 1…e very similar to legally marketed devices listed below in that they share very similar indications for use (compared to devices cleared under K981529, K040212, K040462, K061019, K050226 and K010801), are manufactured from identical material, and incorporate very similar technological design characteristic… | 2006 |
| * | K050226 | Asian Intramedullary Hip Screw NailsSummary page 1…milar to legally marketed devices listed below in that they share very similar indications for use (compared to devices cleared under K981529, K040212, K040462, K061019, K050226 and K010801), are manufactured from identical material, and incorporate very similar technological design characteristics. === P… | 2005 |
| * | K010801 | T2 Femoral NailSummary page 1…ally marketed devices listed below in that they share very similar indications for use (compared to devices cleared under K981529, K040212, K040462, K061019, K050226 and K010801), are manufactured from identical material, and incorporate very similar technological design characteristics. Su… | 2001 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| Mar 18, 2025 | Class II | Z-1806-2025 | Process control | Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- 7 of the 16 ancestors have a recall of any class.
- Of its descendants, K243364 (Smith & Nephew, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 15 other devices also cite its predicate K981529.
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. 2010, this device’s year, is highlighted.
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?
SURESHOT Tm TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the…
Read the full statement (119 words)
SURESHOT Tm TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.
In addition, SURESHOT TM TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.
SURESHOT Tm TAN Nails and Accessories are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092748 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092748: Sureshot Tan Nails and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092748
Report an extraction error
Are you the manufacturer?
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