510(k) · Cleared
ClearedSmartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Biomaterials, Ltd. · HWC Screw, Fixation, Bone
Cleared on Sep 16, 2004 as substantially equivalent to K012001 (Bionx Implants, Ltd., 2001) after a 23-day review. Its family tree reaches back 4 generations to 1979. 1 later device descends from it.
- Decided
- Sep 16, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K792022 (1979). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 3 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 2 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 1 generation backK012001 SmartscrewBionx Implants, Ltd. · 2001
- This deviceK042295 Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK050388 Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005
Most influential descendants
Showing 1 of 1 · See all- K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −3 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −2 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −1 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| 0 (this device) | K042295 | Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020 | Linvatec Biomaterials, Ltd. | 2004 | — |
| +1 | K050388 | Refix Internal Fracture Fixation Screws | Xtremi-T, LLC | 2005 | — |
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 |
|---|---|---|
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K012001 | SmartscrewSummary page 1…able fixation fastener, bone D. Device Product Code: HWC and MAI Predicate Devices: Linvatec Biomaterials (the previous Bionx Implants Ine). SmartScrewTm (K0 1200 1) The predicate device is the previously cleared Linvatec Biomnaterials (the previous Bionx Implants) 0 2.0mm fully threaded, sol… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050388 | Refix Internal Fracture Fixation Screws | 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 25 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K050388 (Xtremi-T, LLC, 2005) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K012001.
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?
SmartScrew® II 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 (159 words)
SmartScrew® II 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, malleolar fractures, ankle fractures, metatarsal osteotomies and correction of hallux valgus.
SmartScrew® II 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). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042295 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042295: Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042295
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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