510(k) · Cleared
ClearedModification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionx Implants, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 21, 2001 as substantially equivalent to K993074 (Bionx Implants, Ltd., 1999) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1987. 4 later devices descend from it.
- Decided
- Nov 21, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K864912 (1987). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK864912 PDS (Polydioxanon) Absorbable PinJohnson & Johnson Professionals, Inc. · 1987
- 2 generations backK993074 Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999
- 1 generation backK012000 1.5MM Bone Fixation KitBionx Implants, Ltd. · 2001
- This deviceK013546 Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK031981 2.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003
- Descendant · 2 generations on · 2 of its ownK041288 Modification to SmartpinLinvatec Biomaterials, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK073311 Osteotrans-OT PinTakiron Co., Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK071616 Arc Surgical Biotrak Pin SystemArc Surgical, LLC · 2007
Most influential descendants
Showing 4 of 4 · See all- K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003 · cites it directly3descendants
- K041288Modification to SmartpinLinvatec Biomaterials, Inc. · 2004 · 2 generations on2descendants
- K073311Osteotrans-OT PinTakiron Co., Ltd. · 2008 · 3 generations on0descendants
- K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864912 | PDS (Polydioxanon) Absorbable Pin | Johnson & Johnson Professionals, Inc. | 1987 | — |
| −2 | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 | Bionx Implants, Ltd. | 1999 | — |
| −1 | K012000 | 1.5MM Bone Fixation Kit | Bionx Implants, Ltd. | 2001 | — |
| 0 (this device) | 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 | — |
| +2 | K041288 | Modification to Smartpin | Linvatec Biomaterials, Inc. | 2004 | — |
| +3 | K073311 | Osteotrans-OT Pin | Takiron Co., Ltd. | 2008 | — |
| +3 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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? (2)
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…ame: Absorbable Bone Fixation Nail C. Classification Name: Bone Fixation Nail D. Device Product Code: MAI and HWC Predicate Device: 1. Bionx Implants, Inc. SmartNail (K993074) 2. Bionx Implants, Inc. 1.5mm Bone Fixation Kit (K012000) Intended Use: Properly used, in the presence of adequate immobilizat… | 1999 |
| * | K012000 | 1.5MM Bone Fixation KitSummary page 1…Bone Fixation Nail D. Device Product Code: MAI and HWC Predicate Device: 1. Bionx Implants, Inc. SmartNail (K993074) 2. Bionx Implants, Inc. 1.5mm Bone Fixation Kit (K012000) Intended Use: Properly used, in the presence of adequate immobilization, 1.5mm Bone Fixation Kit is intended for use in the fi… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445 | 2003 | 3 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K031981 (Linvatec Biomaterials, Ltd., 2003) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K993074.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
1.5mm Bone Fixation Kit 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. 1.5mm Bone Fixation Kit 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…
Read the full statement (122 words)
1.5mm Bone Fixation Kit 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.
1.5mm Bone Fixation Kit 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 and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of 1.5mm Bone Fixation Kit upon the healing of growth plate has not been tested clinically.
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/K013546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013546: Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013546
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026