510(k) · Cleared
ClearedPeek 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 Mar 28, 2014 as substantially equivalent to K050259 (Arthrex, Inc., 2005) and 2 other predicates after a 133-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 28, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K960385 (1996). 17 ancestors in all, the oldest K954330 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 3 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 2 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- 1 generation backK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
- This deviceK133515 Peek Fusion ImplantMtp Solutions, LLC · 2014
- Descendant · cites it directly · 0 of its ownK211996 Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK140970 One-Piece Peek Fusion ImplantMtp Solutions, LLC · 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 |
|---|---|---|---|---|---|
| −4 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −3 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −2 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| −1 | K110445 | Flexfusion (TM) Fixation Implant | Nextremity Solutions, LLC | 2011 | 6 |
| 0 (this device) | K133515 | Peek Fusion Implant | Mtp Solutions, LLC | 2014 | — |
| +1 | K211996 | Nexta PEEK Hammertoe Correction System | Nextremity Solutions, Inc. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K050259 | Arthrex Bio-PinSummary page 1…duction and fixation of the bone fragments. Predicate Devices: The PEEK Fusion Implant is substantially equivalent to the Arthrex Bio-Pin (marketed as the Trim-It Pin) [K050259], the OsteoMed ExtremiFuse [K130412] and the Nextremity FlexFusion Implant (marketed as the Nextra) [Ki 10445] with respect to it… | 2005 |
| * | K130412 | Osteomed Extremifuse SystemSummary page 1…gments. Predicate Devices: The PEEK Fusion Implant is substantially equivalent to the Arthrex Bio-Pin (marketed as the Trim-It Pin) [K050259], the OsteoMed ExtremiFuse [K130412] and the Nextremity FlexFusion Implant (marketed as the Nextra) [Ki 10445] with respect to its indications for use, geometry, dim… | 2013 |
| * | K110445 | Flexfusion (TM) Fixation Implant | 2011 |
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 18 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K211996 (Nextremity Solutions, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K050259.
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 PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133515: Peek Fusion Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133515
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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