510(k) · Cleared
ClearedActiFlip
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 6, 2021 as substantially equivalent to K192750 (Parcus Medical, LLC, 2020) and 3 other predicates after a 37-day review. Its family tree reaches back 14 generations to 1979.
- Decided
- Oct 6, 2021
- Review
- 37 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K792022 (1979). 122 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 deviceK212739 ActiFlipParcus Medical, LLC · 2021
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 deviceK212739 ActiFlipParcus Medical, LLC · 2021
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) | 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 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 10 | 0 |
| 2000 | 7 | 0 |
| 2001 | 11 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipSummary page 4…Device Class: Class ll Regulation Number: 21 CFR 888.3040 Product Code: MBI Predicate Device Information: ActiFlip - K192750 (cleared January 16, 2020), K202259 (cleared October 28, 2020) Mit… | 2020 |
| * | K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Summary page 4…ss ll Regulation Number: 21 CFR 888.3040 Product Code: MBI Predicate Device Information: ActiFlip - K192750 (cleared January 16, 2020), K202259 (cleared October 28, 2020) Miti Suture Anchors – K111000 (cleared… | 2020 |
| * | K111000 | Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorSummary page 4…n: ActiFlip - K192750 (cleared January 16, 2020), K202259 (cleared October 28, 2020) Miti Suture Anchors – K111000 (cleared July 28, 2011), K201083 (cleared July 23, 2020) Reason for 510(k) submission: The purpo… | 2011 |
| * | K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsSummary page 4…nuary 16, 2020), K202259 (cleared October 28, 2020) Miti Suture Anchors – K111000 (cleared July 28, 2011), K201083 (cleared July 23, 2020) Reason for 510(k) submission: The purpose of this Traditional 510(k) is… | 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 42 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 122 ancestors have a recall of any class.
- 1 other device also cites its predicate K192750.
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. 2021, 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 Actiflip is used for fixation of bone to bone or soft tissue to bone, and is intended as a 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…
Read the full statement (115 words)
The Parcus Actiflip is used for fixation of bone to bone or soft tissue to bone, and is intended as a 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 ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, FDL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212739 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212739: ActiFlip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212739
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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