510(k) · Cleared
ClearedCannulated Smartscrew Models 224540C, 224570C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionx Implants, Ltd. · HWC Screw, Fixation, Bone
Cleared on Sep 21, 1999 as substantially equivalent to K952471 (Bioscience, Inc., 1995) and 1 other predicate after a 20-day review. Its family tree reaches back 2 generations to 1979. 413 later devices descend from it.
- Decided
- Sep 21, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K792022 (1979). 7 ancestors in all. 413 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 1 generation backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- This deviceK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- Descendant · cites it directly · 337 of its ownK012001 SmartscrewBionx Implants, Ltd. · 2001
- Descendant · 2 generations on · 333 of its ownK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- Descendant · 4 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
Showing 5 of 413 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 413 · See all- K012001SmartscrewBionx Implants, Ltd. · 2001 · cites it directly337descendants
- K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003 · 2 generations on333descendants
- K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants
- K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 4 generations on94descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −1 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| 0 (this device) | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| +1 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| +2 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| +3 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| +4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| +4 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 9 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 12 | 0 |
| 2014 | 20 | 0 |
| 2015 | 11 | 0 |
| 2016 | 8 | 0 |
| 2017 | 22 | 0 |
| 2018 | 20 | 0 |
| 2019 | 34 | 0 |
| 2020 | 30 | 0 |
| 2021 | 26 | 0 |
| 2022 | 28 | 0 |
| 2023 | 36 | 0 |
| 2024 | 39 | 0 |
| 2025 | 39 | 0 |
| 2026 | 38 | 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 |
|---|---|---|---|
| * | K952471 | Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation RodSummary page 2…on Name: Biodegradable fixation fastener, bone D. Device Product Code: HWC Predicate Devices: Bionx Implants Inc. Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471) Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876) Intended Use: The Cannulated SmartScrew™ is… | 1995 |
| * | K974876 | Bionx Distal Radius ScrewSummary page 2…ate Devices: Bionx Implants Inc. Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471) Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876) Intended Use: The Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of… | 1998 |
What descends from it? (413)
See all 4135 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 20 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K012001 (Bionx Implants, Ltd., 2001) has gone furthest, with 337 descendants of its own.
- 5 other devices also cite its predicate K952471.
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?
Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization. In conjunction with adequate surgical technique and postoperative immobilization, the Cannulated SmartScrew™ provides secure fixation and will maintain sufficient physical integrity and mechanical holding properties within the bone, well beyond the five to eight weeks needed for complete…
Read the full statement (113 words)
Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization. In conjunction with adequate surgical technique and postoperative immobilization, the Cannulated SmartScrew™ provides secure fixation and will maintain sufficient physical integrity and mechanical holding properties within the bone, well beyond the five to eight weeks needed for complete biological healing and realignment of the fixation site.
The Cannulated SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (diaphyseal area), 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).
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/K992947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992947: Cannulated Smartscrew Models 224540C, 224570C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992947
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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