510(k) · Cleared
ClearedBioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioretec, Ltd. · HWC Screw, Fixation, Bone
Cleared on Jun 18, 2008 as substantially equivalent to K072848 (Bioretec, Ltd., 2007) and 2 other predicates after a 30-day review. Its family tree reaches back 6 generations to 1979. 2 later devices descend from it.
- Decided
- Jun 18, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K792022 (1979). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 4 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 3 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 2 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 1 generation backK062617 Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd. · 2006
- This deviceK081392 Bioretec Activascrew, Activascrew Cannulated and Activascrew…Bioretec, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK261057 ActivaScrew™ Cannulated COMBioretec, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK130716 Bioretec Activascrew InterferenceBioretec, Ltd. · 2013
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 |
|---|---|---|---|---|---|
| −6 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −5 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −4 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −3 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −2 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −1 | K062617 | Modification to Inion Otps Biodegradable Fixation System | Inion, Ltd. | 2006 | — |
| 0 (this device) | K081392 | Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with… | Bioretec, Ltd. | 2008 | — |
| +1 | K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | 2026 | — |
| +1 | K130716 | Bioretec Activascrew Interference | Bioretec, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K072848 | ActivascrewSummary page 1JUN 1 8 2008 bioretec G SPECIAL 510(k) SUMMARY For the modification to Bioretec ActivaScrew TM (K072848) MANUFACTURER Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND Contact person: Mrs. Mari Ruotsalainen… | 2007 |
| * | K030900 | Inion Otps Biodegradable Fixaton SystemSummary page 1…Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HWC PREDICATE DEVICES 1. Bioretec ActivaScrewTM (K072848) 2. Inion OTPS TM Biodegradable Fixation System (K030900 and K062617) Special 510(k): Device Modification, Date: May 16T , 2008 Page G-1 bioretec DEVIC… | 2003 |
| * | K062617 | Modification to Inion Otps Biodegradable Fixation SystemSummary page 1…Regulation Number: 21 CFR 888.3040 Product Code: HWC PREDICATE DEVICES 1. Bioretec ActivaScrewTM (K072848) 2. Inion OTPS TM Biodegradable Fixation System (K030900 and K062617) Special 510(k): Device Modification, Date: May 16T , 2008 Page G-1 bioretec DEVICE DESCRIPTIO… | 2006 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K261057 (Bioretec, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072848.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 ActivaScrew TM Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081392 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081392: Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081392
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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