510(k) · Cleared
ClearedOne-Piece Peek Fusion Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mtp Solutions, LLC · HWC Screw, Fixation, Bone
Cleared on May 13, 2014 as substantially equivalent to K133515 (Mtp Solutions, LLC, 2014) and 1 other predicate after a 27-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- May 13, 2014
- Review
- 27 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K960385 (1996). 18 ancestors in all, the oldest K954330 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 4 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 3 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- 2 generations backK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
- 1 generation backK133515 Peek Fusion ImplantMtp Solutions, LLC · 2014
- This deviceK140970 One-Piece Peek Fusion ImplantMtp Solutions, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −4 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −3 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| −2 | K110445 | Flexfusion (TM) Fixation Implant | Nextremity Solutions, LLC | 2011 | 6 |
| −1 | K133515 | Peek Fusion Implant | Mtp Solutions, LLC | 2014 | — |
| 0 (this device) | K140970 | One-Piece Peek Fusion Implant | Mtp Solutions, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K133515 | Peek Fusion ImplantSummary page 2…Page 2 of 2 Predicate Devices: The One-Piece PEEK Fusion Implant is substantially equivalent to the MTP Solutions LLC PEEK Fusion Implant (K1335 15) and Artbrex Bia-Pin device (K050259) with respect to its indications for use, materials, dimensions, function and performance.… | 2014 |
| * | K050259 | Arthrex Bio-PinSummary page 2…f 2 Predicate Devices: The One-Piece PEEK Fusion Implant is substantially equivalent to the MTP Solutions LLC PEEK Fusion Implant (K1335 15) and Artbrex Bia-Pin device (K050259) with respect to its indications for use, materials, dimensions, function and performance. Technological Characteristics Compari… | 2005 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K133515.
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 One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomnies and reconstruction of the lesser toes following correction procedures for hanmmertoe, claw toe and mallet toe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140970 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140970: One-Piece Peek Fusion Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140970
Report an extraction error
Are you the manufacturer?
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