510(k) · Cleared
ClearedTITAN 3-D Wedge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · PLF Bone Wedge
Cleared on Aug 22, 2023 as substantially equivalent to K162241 (Paragon 28, 2017) after a 90-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Aug 22, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K093950 (2010). 7 ancestors in all, the oldest K070592 (2007). No later device cites it as a predicate yet.
- Root · 4 generations backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- 3 generations backK140531 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014
- 2 generations backK142724 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015
- 1 generation backK162241 TITAN 3-D™ Wedge SystemParagon 28 · 2017 · Recalled
- This deviceK231496 TITAN 3-D Wedge SystemParagon 28, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| −3 | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| −2 | K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015 | — |
| −1 | K162241 | TITAN 3-D™ Wedge System | Paragon 28 | 2017 | 1 |
| 0 (this device) | K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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 PLF? 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 PLF device
- #1 K193414 Trigon HA Stand-Alone Wedge Fixation Systemscore 17.8 · 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? (1)
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 |
|---|---|---|---|
| * | K162241 | TITAN 3-D™ Wedge SystemSummary page 4…August 22, 2023 Device Trade Name: TITAN 3-D® Wedge System Device Class: Class II Predicate Device: TITAN 3-D® Wedge System (K162241) Device Description: The TITAN 3-D® Wedge System contains a series of titanium alloy implants… | 2017 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K162241.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PLF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLF
30in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLF
2in 2025
MAUDE reports naming product code PLF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 3 | 30 | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.
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/K231496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231496: TITAN 3-D Wedge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231496
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