510(k) · Cleared
Recalled · Class II · 2015Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · HWC Screw, Fixation, Bone
Cleared on Jul 30, 2014 as substantially equivalent to K022599 (New Deal, S.A., 2002) and 7 other predicates after a 316-day review. Its family tree reaches back 12 generations to 1991. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 30, 2014
- Review
- 316 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 8
Its longest line of descent runs back 12 generations to K911837 (1991). 99 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 8 generations between
- 3 generations backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- 2 generations backK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009
- 1 generation backK102326 Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010
- This deviceK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014
- Descendant · cites it directly · 0 of its ownK222564 Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
Show all 12 generations
- Root · 12 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 11 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 10 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 9 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 8 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 7 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 6 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 5 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 4 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 3 generations backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- 2 generations backK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009
- 1 generation backK102326 Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010
- This deviceK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014
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 |
|---|---|---|---|---|---|
| −12 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −11 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −10 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −9 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −8 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −7 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −6 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −5 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −4 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| −3 | K090075 | Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 | Parcus Medical, LLC | 2009 | — |
| −2 | K091094 | Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264 | Parcus Medical, LLC | 2009 | — |
| −1 | K102326 | Parcus 3.5MM Peek CF Push-in Suture Anchor | Parcus Medical, LLC | 2010 | — |
| 0 (this device) | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant | In2bones Sas | 2014 | — |
| +1 | K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | Treace Medical Concepts, Inc. | 2022 | — |
| +1 | K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 11 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K022599 | Newdeal K WireSummary page 2…hospital, or outpatient surgery center where sterile field may be created and maintained. Predicate Devices Newdeal K-wire (K022599) Metasurg DigiFuse (Kl 11536) Parcus PEEK CF push-in suture anchor (K102326)… | 2002 |
| * | K111536 | Metasurg Digifuse ImplantSummary page 3…interphalangeal implant has similar blade design in its distal part, when compared to the Metasurg DigiFuse implant (K1 11536) and WMT Pro-Toe (K120645). Its shape is also similar to the distal part of the Synchro Toegrip… | 2011 |
| * | K102326 | Parcus 3.5MM Peek CF Push-in Suture AnchorSummary page 2…tained. Predicate Devices Newdeal K-wire (K022599) Metasurg DigiFuse (Kl 11536) Parcus PEEK CF push-in suture anchor (K102326) WMT Pro-Toe (K120645) Arrowhead Arrow-Lok (KI 12675) Smith… | 2010 |
| * | K120645 | Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionSummary page 2…e (K022599) Metasurg DigiFuse (Kl 11536) Parcus PEEK CF push-in suture anchor (K102326) WMT Pro-Toe (K120645) Arrowhead Arrow-Lok (KI 12675) Smith and Nephew Bioraptor 2.3 PIC suture anchor (K… | 2012 |
| * | K112675 | Arrow-Lok Digital System | 2011 |
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 2…WMT Pro-Toe (K120645) Arrowhead Arrow-Lok (KI 12675) Smith and Nephew Bioraptor 2.3 PIC suture anchor (K07 1586) Merete MetaToe (K100414) Synchro Medical Toegrip (K 143477) Indications for use:… | 2007 |
| * | K100414 | Protoe Endosorb Small Hammer Toe PinSummary page 2…Arrowhead Arrow-Lok (KI 12675) Smith and Nephew Bioraptor 2.3 PIC suture anchor (K07 1586) Merete MetaToe (K100414) Synchro Medical Toegrip (K 143477) Indications for use: The DUAFIT® interphalangeal implant is intend… | 2010 |
| * | K133477 | Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis Cleared while this submission was under review Summary page 3…K071586), Metasurg DigiFuse implant (KI 11536) , WMT Pro-Toe (K120645), Merete MetaToe (K100414) and Synchro Toegrip (K133477). -Blade design in its distal part - The DUAFIT® interphalangeal implant has si… | 2014 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2015 | Class II | Z-1318-2015 | Nonconforming Material/Component | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. |
| Mar 9, 2015 | Class II | Z-1319-2015 | Nonconforming Material/Component | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 99 ancestors have a recall of any class.
- Of its descendants, K222564 (Treace Medical Concepts, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 22 other devices also cite its predicate K022599.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The DUAFIT® interphalangeal implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes.
Examples include:
Rigid or semi-rigid deformity of the PIP joint
Revision of failed arthroplasty or arthrodesis
2nd toe shortening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132912: Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132912
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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