510(k) · Cleared
ClearedSmartscrew
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 Jul 18, 2001 as substantially equivalent to K952471 (Bioscience, Inc., 1995) and 3 other predicates after a 21-day review. Its family tree reaches back 3 generations to 1979. 337 later devices descend from it.
- Decided
- Jul 18, 2001
- Review
- 21 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K792022 (1979). 9 ancestors in all. 337 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 2 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 1 generation backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- This deviceK012001 SmartscrewBionx Implants, Ltd. · 2001
- Descendant · cites it directly · 333 of its ownK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- Descendant · 2 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- Descendant · 3 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- Descendant · 3 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- Descendant · 3 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
Showing 5 of 337 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 337 · See all- K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003 · cites it directly333descendants
- K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 2 generations on306descendants
- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 3 generations on217descendants
- K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 3 generations on94descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 3 generations on91descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −2 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −1 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| 0 (this device) | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| +1 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| +2 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| +3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| +3 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| +3 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 9 | 0 |
| 2014 | 18 | 0 |
| 2015 | 10 | 0 |
| 2016 | 7 | 0 |
| 2017 | 15 | 0 |
| 2018 | 16 | 0 |
| 2019 | 28 | 0 |
| 2020 | 25 | 0 |
| 2021 | 24 | 0 |
| 2022 | 24 | 0 |
| 2023 | 28 | 0 |
| 2024 | 37 | 0 |
| 2025 | 31 | 0 |
| 2026 | 36 | 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? (4)
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 1…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, K992947) Bionx Implants Inc. SmartScrew™ (K… | 1995 |
| * | K974876 | Bionx Distal Radius ScrewSummary page 1…e Devices: Bionx Implants Inc. Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471) Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876, K992947) Bionx Implants Inc. SmartScrew™ (K003077) Intended Use: The SmartScrew™ is generally intended for mai… | 1998 |
| * | K992947 | Cannulated Smartscrew Models 224540C, 224570CSummary page 1…: Bionx Implants Inc. Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471) Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876, K992947) Bionx Implants Inc. SmartScrew™ (K003077) Intended Use: The SmartScrew™ is generally intended for maintenance… | 1999 |
| * | K003077 | Smartscrew Model 222006...227510Summary page 1…e SR-PLLA Threaded Fixation Rod (K952471) Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876, K992947) Bionx Implants Inc. SmartScrew™ (K003077) Intended Use: The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, ost… | 2001 |
What descends from it? (337)
See all 3376 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030900 | Inion Otps Biodegradable Fixaton System | 2003 | 333 |
| K023022 | Nugen FX Screw | 2002 | 2 |
| K042295 | Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020 | 2004 | 1 |
| K032447 | Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially Threaded | 2004 | 1 |
| K050388 | Refix Internal Fracture Fixation Screws | 2005 | 0 |
| K043145 | BI-Cortical Bio-Post and Washer, Model AR-1367B | 2005 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K030900 (Inion, Ltd., 2003) has gone furthest, with 333 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?
The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures…
Read the full statement (135 words)
The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.
The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 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/K012001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012001: Smartscrew.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012001
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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