510(k) · Cleared
ClearedParcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
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 Oct 28, 2020 as substantially equivalent to K133757 (Parcus Medical, LLC, 2014) and 6 other predicates after a 79-day review. Its family tree reaches back 13 generations to 1979. 2 later devices descend from it.
- Decided
- Oct 28, 2020
- Review
- 79 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 13 generations to K792022 (1979). 73 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations between
- 3 generations backK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- 2 generations backK152711 Parcus GFS NakedParcus Medical, LLC · 2015
- 1 generation backK192750 AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC · 2020
- This deviceK202259 Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS…Parcus Medical, LLC · 2020
- Descendant · cites it directly · 0 of its ownK213018 Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited · 2022
- Descendant · cites it directly · 0 of its ownK212739 ActiFlipParcus Medical, LLC · 2021
Show all 13 generations
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 12 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 11 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 10 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 9 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 8 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 7 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 6 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 5 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 4 generations backK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- 3 generations backK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- 2 generations backK152711 Parcus GFS NakedParcus Medical, LLC · 2015
- 1 generation backK192750 AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC · 2020
- This deviceK202259 Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS…Parcus Medical, LLC · 2020
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 |
|---|---|---|---|---|---|
| −13 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −12 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −11 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −10 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −9 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −8 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −7 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −6 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −5 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| −4 | K090923 | Parcus Graft Fixation System | Parcus Medical, LLC | 2009 | — |
| −3 | K133757 | GFS II Standard, GFS II Large, GFS Mimi | Parcus Medical, LLC | 2014 | — |
| −2 | K152711 | Parcus GFS Naked | Parcus Medical, LLC | 2015 | — |
| −1 | K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | Parcus Medical, LLC | 2020 | — |
| 0 (this device) | K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ… | Parcus Medical, LLC | 2020 | — |
| +1 | K213018 | Auxilock GFS Mini, GFS II Large, and GFS Ultimate | Auxein Medical Private Limited | 2022 | — |
| +1 | K212739 | ActiFlip | Parcus Medical, LLC | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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? (7)
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 |
|---|---|---|---|
| * | K133757 | GFS II Standard, GFS II Large, GFS MimiSummary page 4…, Soft Tissue Device Class: Class II Classification Name: 21 CFR 888.3040 - Product Code MBI Predicate Device: K133757 (cleared February 4, 2014) – Parcus GFS II and GFS Mini K152711 (cleared November 20, 2015) – Parcus GFS Naked K1… | 2014 |
| * | K152711 | Parcus GFS NakedSummary page 4…assification Name: 21 CFR 888.3040 - Product Code MBI Predicate Device: K133757 (cleared February 4, 2014) – Parcus GFS II and GFS Mini K152711 (cleared November 20, 2015) – Parcus GFS Naked K162198 (cleared November 18, 2016) – Parcus GFS Ultimate K183331… | 2015 |
| * | K162198 | GFS UltimateSummary page 4…Predicate Device: K133757 (cleared February 4, 2014) – Parcus GFS II and GFS Mini K152711 (cleared November 20, 2015) – Parcus GFS Naked K162198 (cleared November 18, 2016) – Parcus GFS Ultimate K183331 (cleared February 7, 2019) – Parcus GFS BTB K190375 (cl… | 2016 |
| * | K183331 | Parcus GFS BTBSummary page 4…14) – Parcus GFS II and GFS Mini K152711 (cleared November 20, 2015) – Parcus GFS Naked K162198 (cleared November 18, 2016) – Parcus GFS Ultimate K183331 (cleared February 7, 2019) – Parcus GFS BTB K190375 (cleared April 24, 2019) – Parcus ATLAS K191783 (cleared Octo… | 2019 |
| * | K190375 | Parcus ATLASSummary page 4…vember 20, 2015) – Parcus GFS Naked K162198 (cleared November 18, 2016) – Parcus GFS Ultimate K183331 (cleared February 7, 2019) – Parcus GFS BTB K190375 (cleared April 24, 2019) – Parcus ATLAS K191783 (cleared October 9, 2019) – Parcus Synd-EZ Ti K192750 (cleared Ja… | 2019 |
| * | K191783 | Parcus Synd-EZ TiSummary page 4…ared November 18, 2016) – Parcus GFS Ultimate K183331 (cleared February 7, 2019) – Parcus GFS BTB K190375 (cleared April 24, 2019) – Parcus ATLAS K191783 (cleared October 9, 2019) – Parcus Synd-EZ Ti K192750 (cleared January 16th, 2020) – Parcus Actiflip Naked, Actiflip Cinc… | 2019 |
| * | K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipSummary page 4…(cleared February 7, 2019) – Parcus GFS BTB K190375 (cleared April 24, 2019) – Parcus ATLAS K191783 (cleared October 9, 2019) – Parcus Synd-EZ Ti K192750 (cleared January 16th, 2020) – Parcus Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip Devi… | 2020 |
What descends from it? (2)
2 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 41 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 73 ancestors have a recall of any class.
- Of its descendants, K213018 (Auxein Medical Private Limited, 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K133757.
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. 2020, 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 II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The GFS BTB devices are indicated for…
Read the full statement (289 words)
The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair
The Parcus ATLAS is indicated for adjunct fixation of the 1st and 2nd metacarpals in CMC arthroplasty.
The Parcus Actiflip Naked, Actiflip Cinch, and Actiflip Whip are used for fixation of bone to bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
The Parcus Synd-EZ Ti are intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ Ti are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202259: Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202259
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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