510(k) · Cleared
Recalled · Class II · 2026Smith & Nephew Intramedullary Nail Systems
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 Nov 14, 2022 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 8 other predicates after a 592-day review. Its family tree reaches back 4 generations to 1995. It has been recalled 4 times.
- Decided
- Nov 14, 2022
- Review
- 592 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 4
- Predicates
- 9
Its longest line of descent runs back 4 generations to K951740 (1995). 17 ancestors in all, the oldest K893377 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 3 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 2 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 1 generation backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- This deviceK210980 Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −3 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −2 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −1 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| 0 (this device) | K210980 | Smith & Nephew Intramedullary Nail Systems | Smith & Nephew, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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? (9)
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 10…Device: Smith & Nephew Intramedullary Nail Systems • Trigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006) • Tr… | 1998 |
| * | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial NailsSummary page 10…ew Intramedullary Nail Systems • Trigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006) • Trigen Tan/Fan Nailing Sy… | 2005 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 10…rigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006) • Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998… | 2006 |
| * | K040929 | Trigen Adolescent TanSummary page 10…S.E. 6/30/2005 and K061019 S.E. 6/6/2006) • Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998 K040929 S.E.5/25/2004, and K111025 S.E. 7/1/2011) • Trigen Hindfoot Fusion Na… | 2004 |
| * | K111025 | Trigen Low Profile Bone ScrewSummary page 10…and K061019 S.E. 6/6/2006) • Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998 K040929 S.E.5/25/2004, and K111025 S.E. 7/1/2011) • Trigen Hindfoot Fusion Nail System (K043052… | 2011 |
| * | K043052 | Trigen Hindfoot Fusion NailSummary page 10…7/9/1998 K040929 S.E.5/25/2004, and K111025 S.E. 7/1/2011) • Trigen Hindfoot Fusion Nail System (K043052 S.E. 11/24/2004) • Trigen Humeral Nail System (K032722 S.E.… | 2004 |
| * | K032722 | Trigen Straight Humeral Nail SystemSummary page 10…• Trigen Hindfoot Fusion Nail System (K043052 S.E. 11/24/2004) • Trigen Humeral Nail System (K032722 S.E. 10/1/2003) • Trigen Intertan Intertrochanteric Antegrade Nail… | 2003 |
| * | K040212 | Trigen IntertanSummary page 10…722 S.E. 10/1/2003) • Trigen Intertan Intertrochanteric Antegrade Nail System (K040212 S.E. 2/20/2004) • Trigen Knee Fusion Nail System (K050938 S.E. 5/4/2… | 2004 |
| * | K050938 | Knee Fusion NailSummary page 10…Intertan Intertrochanteric Antegrade Nail System (K040212 S.E. 2/20/2004) • Trigen Knee Fusion Nail System (K050938 S.E. 5/4/2005) 5-2… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2026 | Class II | Z-2456-2026 | Process control | Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same… |
| 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… |
| Jul 24, 2023 | Class II | Z-2443-2023 | Process control | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described… |
| Jul 24, 2023 | Class II | Z-2444-2023 | Process control | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- 7 of the 17 ancestors have a recall of any class.
- 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. 2022, 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?
Indications for interlocking intramedullary nails include 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. Interlocking intramedullary nails are indicated for fixation of fractures…
Read the full statement (521 words)
Indications for interlocking intramedullary nails include 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. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.
In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).
Indications for interlocking intramedullary nails include 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. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.
In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).
Indications for the TRIGEN Hindfoot Fusion Nail (HFN) include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.
The TRIGEN Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.
The TRIGEN InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures.
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210980: Smith & Nephew Intramedullary Nail Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210980
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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