510(k) · Cleared
ClearedTreace Medical Concepts (TMC) Hammertoe Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Treace Medical Concepts, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 15, 2022 as substantially equivalent to K132912 (In2bones Sas, 2014) and 1 other predicate after an 83-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Nov 15, 2022
- Review
- 83 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K911837 (1991). 104 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 9 generations between
- 3 generations backK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009
- 2 generations backK102326 Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010
- 1 generation backK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · Recalled
- This deviceK222564 Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 12 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 11 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 10 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 9 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 8 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 7 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 6 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 5 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 4 generations backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- 3 generations backK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009
- 2 generations backK102326 Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010
- 1 generation backK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · Recalled
- This deviceK222564 Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −12 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −11 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −10 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −9 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −8 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −7 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −6 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −5 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| −4 | K090075 | Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 | Parcus Medical, LLC | 2009 | — |
| −3 | K091094 | Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264 | Parcus Medical, LLC | 2009 | — |
| −2 | K102326 | Parcus 3.5MM Peek CF Push-in Suture Anchor | Parcus Medical, LLC | 2010 | — |
| −1 | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant | In2bones Sas | 2014 | 2 |
| 0 (this device) | K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | Treace Medical Concepts, Inc. | 2022 | — |
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 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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? (2)
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 |
|---|---|---|---|
| * | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantSummary page 4…er: 21 CFR 888.3040 Smooth or Threaded Metallic Bone Fixation Fastener Panel: Orthopedic Product Code: HWC Primary Predicate: K132912 In2Bones SAS, Duafit® interphalangeal implant Additional Predicate: K140148, Wright Medical Technology Inc., PRO-TOE®… | 2014 |
| * | K140148 | Pro-Toe Hammertoe Fixation SystemSummary page 4…Fastener Panel: Orthopedic Product Code: HWC Primary Predicate: K132912 In2Bones SAS, Duafit® interphalangeal implant Additional Predicate: K140148, Wright Medical Technology Inc., PRO-TOE® Hammertoe Fixation System… | 2014 |
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 31 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
- 11 of the 104 ancestors have a recall of any class.
- 1 other device also cites its predicate K132912.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 TMC Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the TMC Hammertoe Fixation System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint). The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone…
Read the full statement (109 words)
The TMC Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the TMC Hammertoe Fixation System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222564: Treace Medical Concepts (TMC) Hammertoe Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222564
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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