510(k) · Cleared
ClearedParcus Graft Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parcus Medical, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 30, 2009 as substantially equivalent to K980155 (Smith & Nephew, Inc., 1998) and 2 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1979. 21 later devices descend from it.
- Decided
- Jun 30, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K792022 (1979). 55 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 1 generation backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- This deviceK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- Descendant · cites it directly · 16 of its ownK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- Descendant · 2 generations on · 9 of its ownK160655 OrthoButton CLRiverpoint Medical · 2016
- Descendant · 3 generations on · 8 of its ownK171060 OrthoButton ALRiverpoint Medical · 2017
- Descendant · cites it directly · 8 of its ownK162198 GFS UltimateParcus Medical, LLC · 2016
- Descendant · 2 generations on · 5 of its ownK191783 Parcus Synd-EZ TiParcus Medical, LLC · 2019
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 1 generation backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- This deviceK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014 · cites it directly16descendants
- K160655OrthoButton CLRiverpoint Medical · 2016 · 2 generations on9descendants
- K171060OrthoButton ALRiverpoint Medical · 2017 · 3 generations on8descendants
- K162198GFS UltimateParcus Medical, LLC · 2016 · cites it directly8descendants
- K191783Parcus Synd-EZ TiParcus Medical, LLC · 2019 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −1 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| 0 (this device) | K090923 | Parcus Graft Fixation System | Parcus Medical, LLC | 2009 | — |
| +1 | K133757 | GFS II Standard, GFS II Large, GFS Mimi | Parcus Medical, LLC | 2014 | — |
| +2 | K160655 | OrthoButton CL | Riverpoint Medical | 2016 | — |
| +3 | K171060 | OrthoButton AL | Riverpoint Medical | 2017 | — |
| +1 | K162198 | GFS Ultimate | Parcus Medical, LLC | 2016 | — |
| +2 | K191783 | Parcus Synd-EZ Ti | Parcus Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K980155 | Endobutton Continuous LoopSummary page 1…Fastener, Fixation, Non-Degradable soft Tissue 210CFR 888.3040-' Product"Code HWC and, M3BI, PredicatebDevices: · smith & Nephew EndoButtn:;(K980155 K081098) * ConMed Linvatec XO Button (K070780) Dev ic Description: The Parcus6 FS is aitniu ipant assembled with# suture thread… | 1998 |
| * | K081098 | Endobutton Continuous Loop (CL)Summary page 1…er, Fixation, Non-Degradable soft Tissue 210CFR 888.3040-' Product"Code HWC and, M3BI, PredicatebDevices: · smith & Nephew EndoButtn:;(K980155 K081098) * ConMed Linvatec XO Button (K070780) Dev ic Description: The Parcus6 FS is aitniu ipant assembled with# suture threaded throu… | 2008 |
| * | K070780 | Conmed Linvatec XO ButtonSummary page 1…210CFR 888.3040-' Product"Code HWC and, M3BI, PredicatebDevices: · smith & Nephew EndoButtn:;(K980155 K081098) * ConMed Linvatec XO Button (K070780) Dev ic Description: The Parcus6 FS is aitniu ipant assembled with# suture threaded throughifour hoes cretedby his poes… | 2007 |
What descends from it? (21)
See all 212 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 30 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 55 ancestors have a recall of any class.
- Of its descendants, K133757 (Parcus Medical, LLC, 2014) has gone furthest, with 16 descendants of its own.
- 13 other devices also cite its predicate K980155.
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. 2009, 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 Parcus GFS is 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/K090923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090923: Parcus Graft Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090923
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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