510(k) · Cleared
ClearedThreaded Peek K-Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mtp Solutions, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Apr 7, 2014 as substantially equivalent to K101679 (Arthrex, Inc., 2010) and 5 other predicates after a 168-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Apr 7, 2014
- Review
- 168 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K961555 (1996). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 1 generation backK101679 Arthrex Pushlock AnchorsArthrex, Inc. · 2010
- This deviceK133235 Threaded Peek K-WireMtp Solutions, LLC · 2014
- Descendant · cites it directly · 0 of its ownK160118 STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC · 2016
- Descendant · cites it directly · 0 of its ownK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
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 |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −2 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −1 | K101679 | Arthrex Pushlock Anchors | Arthrex, Inc. | 2010 | — |
| 0 (this device) | K133235 | Threaded Peek K-Wire | Mtp Solutions, LLC | 2014 | — |
| +1 | K160118 | STROPP (Single Tunnel Repair of Plantar Plate) | Crossroads Extremity Systems, LLC | 2016 | — |
| +1 | K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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? (6)
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 |
|---|---|---|---|
| * | K101679 | Arthrex Pushlock AnchorsSummary page 2…PEEK K-Wire is the same as described in the Arthrex PushLock predicates. Therefore, the Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushL-ock (K101679, K082810,1K071177, K(063479, K061863, K(051219). * DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2010 |
| * | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Summary page 2…Page 2 of 2 Predicate Devices: The Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushLock (Kl0l679, K082810, K071177, K063479, K(061863, K0512l9) with respect to its indications for use, principles of operation, materials and design. Te… | 2009 |
| * | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Summary page 2…Page 2 of 2 Predicate Devices: The Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushLock (Kl0l679, K082810, K071177, K063479, K(061863, K0512l9) with respect to its indications for use, principles of operation, materials and design. Technologic… | 2007 |
| * | K063479 | Arthrex PushlockSummary page 2…Page 2 of 2 Predicate Devices: The Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushLock (Kl0l679, K082810, K071177, K063479, K(061863, K0512l9) with respect to its indications for use, principles of operation, materials and design. Technological Charac… | 2006 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 2…in the Arthrex PushLock predicates. Therefore, the Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushL-ock (K101679, K082810,1K071177, K(063479, K061863, K(051219). * DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser… | 2006 |
| * | K051219 | PushlockSummary page 2…hrex PushLock predicates. Therefore, the Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushL-ock (K101679, K082810,1K071177, K(063479, K061863, K(051219). * DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2005 |
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 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K160118 (Crossroads Extremity Systems, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate K101679.
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. 2014, 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 Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133235: Threaded Peek K-Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133235
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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