510(k) · Cleared
ClearedN8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial Implant, Various Class I Ancill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Apr 1, 2014 as substantially equivalent to K083070 (Biomet Sports Medicine, 2008) and 3 other predicates after a 127-day review. Its family tree reaches back 9 generations to 1990. 2 later devices descend from it.
- Decided
- Apr 1, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K904436 (1990). 63 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations between
- 3 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 2 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 1 generation backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK133606 N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral…ArthroCare Corporation · 2014
- Descendant · cites it directly · 1 of its ownK153186 Adjustable Fixation DeviceArthrocare Corp. · 2016
- Descendant · 2 generations on · 0 of its ownK222971 ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB…Smith & Nephew, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 8 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 7 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 6 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 5 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 4 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 3 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 2 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 1 generation backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK133606 N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral…ArthroCare Corporation · 2014
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 |
|---|---|---|---|---|---|
| −9 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −8 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −7 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −6 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −5 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −4 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −3 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −2 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −1 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| 0 (this device) | K133606 | N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE… | ArthroCare Corporation | 2014 | — |
| +1 | K153186 | Adjustable Fixation Device | Arthrocare Corp. | 2016 | — |
| +2 | K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable… | Smith & Nephew, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (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 |
|---|---|---|---|
| * | K083070 | Toggleloc SystemSummary page 1…ate devices for the N8TIVE ACL Anatomic Reconstruction System are: * For the N8TIVE ACL Femoral Implant, the Biomet ToggleLoc Femoral Fixation Device cleared under K083070 and K130033. * For the N8TIVE ACL Tibial Implant, the Arthrex Interference Screws cleared under K(052607 and K062466. The t… | 2008 |
| * | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Summary page 1…for the N8TIVE ACL Anatomic Reconstruction System are: * For the N8TIVE ACL Femoral Implant, the Biomet ToggleLoc Femoral Fixation Device cleared under K083070 and K130033. * For the N8TIVE ACL Tibial Implant, the Arthrex Interference Screws cleared under K(052607 and K062466. The tables on the… | 2013 |
| * | K052607 | Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed…Summary page 2…terference Screws Artlrex Interference Screws NSTWVE Tibia] Implant Charcteristicsi K052607, K(062466 proposed Device Intended Use Fixation of Soft Tissue to Bone… | 2005 |
| * | K062466 | Arthrex Interference ScrewSummary page 1…eLoc Femoral Fixation Device cleared under K083070 and K130033. * For the N8TIVE ACL Tibial Implant, the Arthrex Interference Screws cleared under K(052607 and K062466. The tables on the following page provide a comparison of the technological characteristics for the NSTIVE ACL Implants and the p… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153186 | Adjustable Fixation Device | 2016 | 1 |
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 24 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 63 ancestors have a recall of any class.
- Of its descendants, K153186 (Arthrocare Corp., 2016) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K083070.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The N8TIVE™ ACL Anatomic Reconstruction System is indicated for use in the fixation of soft tissue grafts to bone during anterior cruciate ligament reconstruction surgeries of the knee.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133606: N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial Implant, Various Class I Ancill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133606
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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