510(k) · Cleared
ClearedGFS Ultimate
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 Nov 18, 2016 as substantially equivalent to K090923 (Parcus Medical, LLC, 2009) after a 105-day review. Its family tree reaches back 10 generations to 1979. 8 later devices descend from it.
- Decided
- Nov 18, 2016
- Review
- 105 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K792022 (1979). 56 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations between
- 3 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 2 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 1 generation backK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- This deviceK162198 GFS UltimateParcus Medical, LLC · 2016
- Descendant · cites it directly · 5 of its ownK191783 Parcus Synd-EZ TiParcus Medical, LLC · 2019
- Descendant · cites it directly · 3 of its ownK192750 AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC · 2020
- Descendant · cites it directly · 3 of its ownK183331 Parcus GFS BTBParcus Medical, LLC · 2019
- Descendant · cites it directly · 2 of its ownK202259 Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS…Parcus Medical, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK192964 Parcus Synd-EZ SSParcus Medical, LLC · 2019
Show all 10 generations
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 8 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 7 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 6 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 5 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 4 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 3 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 2 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 1 generation backK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- This deviceK162198 GFS UltimateParcus Medical, LLC · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K191783Parcus Synd-EZ TiParcus Medical, LLC · 2019 · cites it directly5descendants
- K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC · 2020 · cites it directly3descendants
- K183331Parcus GFS BTBParcus Medical, LLC · 2019 · cites it directly3descendants
- K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC · 2020 · cites it directly2descendants
- K192964Parcus Synd-EZ SSParcus Medical, LLC · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −9 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −8 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −7 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −6 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −5 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −3 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −2 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| −1 | K090923 | Parcus Graft Fixation System | Parcus Medical, LLC | 2009 | — |
| 0 (this device) | K162198 | GFS Ultimate | Parcus Medical, LLC | 2016 | — |
| +1 | K191783 | Parcus Synd-EZ Ti | Parcus Medical, LLC | 2019 | — |
| +1 | K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | Parcus Medical, LLC | 2020 | — |
| +1 | K183331 | Parcus GFS BTB | Parcus Medical, LLC | 2019 | — |
| +1 | K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ… | Parcus Medical, LLC | 2020 | — |
| +2 | K192964 | Parcus Synd-EZ SS | 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 |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K090923 | Parcus Graft Fixation SystemSummary page 4…Soft Tissue 21 CFR 888.3040 - Product Code MBI Predicate Device: The predicate devices are the Parcus GFS, K090923, cleared June 30, 2009. Device Description: The GFS Ultimate devices are designed f… | 2009 |
What descends from it? (8)
4 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 37 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 56 ancestors have a recall of any class.
- Of its descendants, K191783 (Parcus Medical, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K090923.
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. 2016, 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 GFS Ultimate 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/K162198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162198: GFS Ultimate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162198
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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