510(k) · Cleared
Recalled · Class II · 2018TITAN 3-D™ Wedge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28 · PLF Bone Wedge
Cleared on Apr 3, 2017 as substantially equivalent to K142724 (Wrightmedicaltechnologyinc, 2015) and 1 other predicate after a 236-day review. Its family tree reaches back 3 generations to 2010. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 3, 2017
- Review
- 236 days
- Class
- Class II
- Product code
- PLF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K093950 (2010). 6 ancestors in all, the oldest K070592 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- 2 generations backK140531 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014
- 1 generation backK142724 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015
- This deviceK162241 TITAN 3-D™ Wedge SystemParagon 28 · 2017
- Descendant · cites it directly · 0 of its ownK252733 ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026
- Descendant · cites it directly · 0 of its ownK231496 TITAN 3-D Wedge SystemParagon 28, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −3 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| −2 | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| −1 | K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015 | — |
| 0 (this device) | K162241 | TITAN 3-D™ Wedge System | Paragon 28 | 2017 | — |
| +1 | K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K142724 | BIOFOAM Bone WedgeSummary page 4…e manufactured from medical grade titanium alloy (per ASTM F2924). Primary Predicate: BIOFOAM® Bone Wedge (Wright Medical Technology, Inc. – K142724) Additional Predicate: 4Web Osteotomy Bone Wedge (4Web Inc. – K130185) Performance Data: Static and dynamic compression,… | 2015 |
| * | K130185 | 4WEB Osteotomy Bone WedgeSummary page 4…(per ASTM F2924). Primary Predicate: BIOFOAM® Bone Wedge (Wright Medical Technology, Inc. – K142724) Additional Predicate: 4Web Osteotomy Bone Wedge (4Web Inc. – K130185) Performance Data: Static and dynamic compression, and static compression-shear testing was perform… | 2013 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2018 | Class II | Z-0662-2020 | Error in labeling | It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K252733 (MiRus, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K142724.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 intended 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 intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162241: 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/K162241
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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