510(k) · Cleared
ClearedAuxilock GFS Mini, GFS II Large, and GFS Ultimate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxein Medical Private Limited · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 18, 2022 as substantially equivalent to K202259 (Parcus Medical, LLC, 2020) after a 424-day review. Its family tree reaches back 14 generations to 1979.
- Decided
- Nov 18, 2022
- Review
- 424 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K792022 (1979). 74 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations between
- 3 generations backK152711 Parcus GFS NakedParcus Medical, LLC · 2015
- 2 generations backK192750 AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC · 2020
- 1 generation backK202259 Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS…Parcus Medical, LLC · 2020
- This deviceK213018 Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited · 2022
Show all 14 generations
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 13 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 12 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 11 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 10 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 9 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 8 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 7 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 6 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 5 generations backK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- 4 generations backK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- 3 generations backK152711 Parcus GFS NakedParcus Medical, LLC · 2015
- 2 generations backK192750 AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC · 2020
- 1 generation backK202259 Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS…Parcus Medical, LLC · 2020
- This deviceK213018 Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −13 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −12 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −11 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −10 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −9 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −8 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −7 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −6 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| −5 | K090923 | Parcus Graft Fixation System | Parcus Medical, LLC | 2009 | — |
| −4 | K133757 | GFS II Standard, GFS II Large, GFS Mimi | Parcus Medical, LLC | 2014 | — |
| −3 | K152711 | Parcus GFS Naked | Parcus Medical, LLC | 2015 | — |
| −2 | K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | Parcus Medical, LLC | 2020 | — |
| −1 | K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ… | Parcus Medical, LLC | 2020 | — |
| 0 (this device) | K213018 | Auxilock GFS Mini, GFS II Large, and GFS Ultimate | Auxein Medical Private Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 4 | 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? (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 |
|---|---|---|---|
| * | K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Summary page 5…substantial equivalence: The following is the range of variants covered with their corresponding predicate devices. 510K Number K202259 Applicant Parcus Medical, LLC Common Name Fas… | 2020 |
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 43 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 74 ancestors have a recall of any class.
- 1 other device also cites its predicate K202259.
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. 2022, 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?
Auxilock GFS Mini, GFS II Large, GFS Ultimate Mini and GFS Ultimate Large are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213018: Auxilock GFS Mini, GFS II Large, and GFS Ultimate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213018
Report an extraction error
Are you the manufacturer?
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