510(k) · Cleared
ClearedModification to Smartpin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Biomaterials, Inc. · HTY Pin, Fixation, Smooth
Cleared on Jun 10, 2004 as substantially equivalent to K010983 (Bionx Implants, Inc., 2001) and 4 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1987. 2 later devices descend from it.
- Decided
- Jun 10, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K864912 (1987). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK864912 PDS (Polydioxanon) Absorbable PinJohnson & Johnson Professionals, Inc. · 1987
- 4 generations backK993074 Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999
- 3 generations backK012000 1.5MM Bone Fixation KitBionx Implants, Ltd. · 2001
- 2 generations backK013546 Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001
- 1 generation backK031981 2.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003
- This deviceK041288 Modification to SmartpinLinvatec Biomaterials, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK073311 Osteotrans-OT PinTakiron Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK071616 Arc Surgical Biotrak Pin SystemArc Surgical, LLC · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864912 | PDS (Polydioxanon) Absorbable Pin | Johnson & Johnson Professionals, Inc. | 1987 | — |
| −4 | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 | Bionx Implants, Ltd. | 1999 | — |
| −3 | K012000 | 1.5MM Bone Fixation Kit | Bionx Implants, Ltd. | 2001 | — |
| −2 | K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214 | Bionx Implants, Inc. | 2001 | — |
| −1 | K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445 | Linvatec Biomaterials, Ltd. | 2003 | — |
| 0 (this device) | K041288 | Modification to Smartpin | Linvatec Biomaterials, Inc. | 2004 | — |
| +1 | K073311 | Osteotrans-OT Pin | Takiron Co., Ltd. | 2008 | — |
| +1 | 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 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K010983 | Plla PinSummary page 1…evice Product Code: class II, HTY Predicate Device: 1. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartPin® (the previous PLLA Pin) (K010983), 2. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartPin® PDX (the previous PLGA Pin) (K003659), 3. Linv… | 2001 |
| * | K003659 | Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260Summary page 1…ants, Inc.) SmartPin® (the previous PLLA Pin) (K010983), 2. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartPin® PDX (the previous PLGA Pin) (K003659), 3. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) Biofix SR-PGA Pin (K890902), 4. Linvatec Biomaterials Lt… | 2001 |
| * | K890902 | Biofix* Biodegradable Fixation RodSummary page 1…vious Bionx Implants, Inc.) SmartPin® PDX (the previous PLGA Pin) (K003659), 3. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) Biofix SR-PGA Pin (K890902), 4. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartNail® (K993074, K031981) Intended Use: SmartPin®… | 1989 |
| * | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Summary page 1…c Biomaterials Ltd (the previous Bionx Implants, Inc.) Biofix SR-PGA Pin (K890902), 4. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartNail® (K993074, K031981) Intended Use: SmartPin® is indicated for fixation of fragments of fractured non-load bearing bones, osteotomies an… | 1999 |
| * | K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445Summary page 1…rials Ltd (the previous Bionx Implants, Inc.) Biofix SR-PGA Pin (K890902), 4. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartNail® (K993074, K031981) Intended Use: SmartPin® is indicated for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrod… | 2003 |
What descends from it? (2)
2 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)
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 17 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K073311 (Takiron Co., Ltd., 2008) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K010983.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
SmartPin® 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. SmartPin® is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of conical bone (except conical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous…
Read the full statement (113 words)
SmartPin® 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.
SmartPin® is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of conical bone (except conical 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 and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) treatment of physeal fractures in children, because the effect of SmartPin® upon the healing of growth plate has not been tested clinically.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041288: Modification to Smartpin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041288
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