510(k) · Cleared
ClearedBioretec Activascrew Interference
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioretec, Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Aug 28, 2013 as substantially equivalent to K071464 (Inion OY, 2007) and 8 other predicates after a 166-day review. Its family tree reaches back 7 generations to 1979.
- Decided
- Aug 28, 2013
- Review
- 166 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 7 generations to K792022 (1979). 45 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 5 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 4 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 3 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 2 generations backK062617 Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd. · 2006
- 1 generation backK081392 Bioretec Activascrew, Activascrew Cannulated and Activascrew…Bioretec, Ltd. · 2008
- This deviceK130716 Bioretec Activascrew InterferenceBioretec, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −6 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −5 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −4 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −2 | K062617 | Modification to Inion Otps Biodegradable Fixation System | Inion, Ltd. | 2006 | — |
| −1 | K081392 | Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with… | Bioretec, Ltd. | 2008 | — |
| 0 (this device) | K130716 | Bioretec Activascrew Interference | Bioretec, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K071464 | Inion Hexalon Biodegradable Acl/PCL ScrewSummary page 2…K(130716 (2/3) bior-etec PREDICATE DEVICES 1. Inion Hexalon Tm Biodegradable ACL/PCL Screw (K(071464) 2. Arthrex Bio-Tenodesis TM Screw from Tenodesis TM Screw Family (1(010525, K(011007, 1(020043,1(041356, K051726) 3. Biorete… | 2007 |
| * | K010525 | Arthrex Tenodesis Screw 7MM, 8MM, 9MMSummary page 2…0716 (2/3) bior-etec PREDICATE DEVICES 1. Inion Hexalon Tm Biodegradable ACL/PCL Screw (K(071464) 2. Arthrex Bio-Tenodesis TM Screw from Tenodesis TM Screw Family (1(010525, K(011007, 1(020043,1(041356, K051726) 3. Bioretec ActivaScrew TM (K(062980,K1(72848,K(081392) DEVICE DESCRIPTION AND PRIN… | 2001 |
| * | K011007 | Tenodesis Screw, 5.5 MM, Model AR-1350-55Summary page 2…s the predicate devices Inion Hexalon TM Biodegradable ACL/PCL Screw (K(071464) and Arthrex Bio-Tenodesis TM Screw from Tenodesis TM Screw Family (1(010525, K011007, K020043, K(041356, K(051726). The material of the ActivaScrewTM Interference is the same as the material of the previously clear… | 2001 |
| * | K020043 | 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw…Summary page 2…dicate devices Inion Hexalon TM Biodegradable ACL/PCL Screw (K(071464) and Arthrex Bio-Tenodesis TM Screw from Tenodesis TM Screw Family (1(010525, K011007, K020043, K(041356, K(051726). The material of the ActivaScrewTM Interference is the same as the material of the previously cleared Activa… | 2002 |
| * | K041356 | Arthrex Tenodesis Screw FamilySummary page 2…E DEVICES 1. Inion Hexalon Tm Biodegradable ACL/PCL Screw (K(071464) 2. Arthrex Bio-Tenodesis TM Screw from Tenodesis TM Screw Family (1(010525, K(011007, 1(020043,1(041356, K051726) 3. Bioretec ActivaScrew TM (K(062980,K1(72848,K(081392) DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION The ActivaScr… | 2004 |
| * | K051726 | Arthrex Tenodesis FamilySummary page 2…S 1. Inion Hexalon Tm Biodegradable ACL/PCL Screw (K(071464) 2. Arthrex Bio-Tenodesis TM Screw from Tenodesis TM Screw Family (1(010525, K(011007, 1(020043,1(041356, K051726) 3. Bioretec ActivaScrew TM (K(062980,K1(72848,K(081392) DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION The ActivaScrewiM Inte… | 2005 |
| * | K062980 | ActivascrewSummary page 2…/PCL Screw (K(071464) 2. Arthrex Bio-Tenodesis TM Screw from Tenodesis TM Screw Family (1(010525, K(011007, 1(020043,1(041356, K051726) 3. Bioretec ActivaScrew TM (K(062980,K1(72848,K(081392) DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION The ActivaScrewiM Interference is indicated for fixation of… | 2006 |
| * | K072848 | ActivascrewSummary page 2…K011007, K020043, K(041356, K(051726). The material of the ActivaScrewTM Interference is the same as the material of the previously cleared ActivaScrew' TM (1(062980, 1(072848, K(081392). The performance of the ActivaScrewT Interference was compared to the predicate devices by pull-out testing,… | 2007 |
| * | K081392 | Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinSummary page 2…64) 2. Arthrex Bio-Tenodesis TM Screw from Tenodesis TM Screw Family (1(010525, K(011007, 1(020043,1(041356, K051726) 3. Bioretec ActivaScrew TM (K(062980,K1(72848,K(081392) DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION The ActivaScrewiM Interference is indicated for fixation of tissue, including… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 45 ancestors have a recall of any class.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The ActivaScrew Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130716: Bioretec Activascrew Interference.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130716
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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