510(k) · Cleared
Cleared2.4 Smartnail, Models 532416, 532425, 532435, 532445
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Biomaterials, Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jul 25, 2003 as substantially equivalent to K993074 (Bionx Implants, Ltd., 1999) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1987. 3 later devices descend from it.
- Decided
- Jul 25, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K864912 (1987). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK864912 PDS (Polydioxanon) Absorbable PinJohnson & Johnson Professionals, Inc. · 1987
- 3 generations backK993074 Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999
- 2 generations backK012000 1.5MM Bone Fixation KitBionx Implants, Ltd. · 2001
- 1 generation backK013546 Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001
- This deviceK031981 2.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK041288 Modification to SmartpinLinvatec Biomaterials, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK073311 Osteotrans-OT PinTakiron Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK071616 Arc Surgical Biotrak Pin SystemArc Surgical, LLC · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864912 | PDS (Polydioxanon) Absorbable Pin | Johnson & Johnson Professionals, Inc. | 1987 | — |
| −3 | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 | Bionx Implants, Ltd. | 1999 | — |
| −2 | K012000 | 1.5MM Bone Fixation Kit | Bionx Implants, Ltd. | 2001 | — |
| −1 | K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214 | Bionx Implants, Inc. | 2001 | — |
| 0 (this device) | K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445 | Linvatec Biomaterials, Ltd. | 2003 | — |
| +1 | K041288 | Modification to Smartpin | Linvatec Biomaterials, Inc. | 2004 | — |
| +2 | K073311 | Osteotrans-OT Pin | Takiron Co., Ltd. | 2008 | — |
| +2 | K071616 | Arc Surgical Biotrak Pin System | Arc Surgical, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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 |
|---|---|---|---|
| * | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Summary page 1…Bone Fixation Nail D. Device Product Code: MA1 and H WC Predicate Device: 1. Linvatec Biomaterials Ltd (the previous Bioiix Implants, Inc.) SmartNail (K993074) 2. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) 1.5mm Bone Fixation Kit (KO12000, K013546) Intended Use: P… | 1999 |
| * | K012000 | 1.5MM Bone Fixation Kit | 2001 |
| * | K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Summary page 1…als Ltd (the previous Bioiix Implants, Inc.) SmartNail (K993074) 2. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) 1.5mm Bone Fixation Kit (KO12000, K013546) Intended Use: Properly used, in the presence of adequate immobilization, 2.4 SmartNail is intended for use in the fixation of… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041288 | Modification to Smartpin | 2004 | 2 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K041288 (Linvatec Biomaterials, Inc., 2004) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K993074.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
2.4 SmartNail is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. 2.4 SmartNail is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing…
Read the full statement (128 words)
2.4 SmartNail is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
2.4 SmartNail is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed, (e.g., alcoholism) 4) Treatment of physeal fractures in children, because the effect of 2.4 SmartNail upon the healing of growth plate has not been tested clinically.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031981: 2.4 Smartnail, Models 532416, 532425, 532435, 532445.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031981
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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