510(k) · Cleared
ClearedDePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · FTM Mesh, Surgical
Cleared on Mar 13, 2019 as substantially equivalent to K051879 (Synthes (Usa), 2005) and 6 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Mar 13, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K922489 (1992). 8 ancestors in all, the oldest K832283 (1984). No later device cites it as a predicate yet.
- Root · 2 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 1 generation backK022665 Porous Hdpe Surgical Implants, to BE Distributed Under Various…Hohenstein Enterprises, Inc. · 2002
- This deviceK183472 DePuy Synthes Porous Polyethylene Implants and Titanium Wires…Synthes (USA) Products, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −1 | K022665 | Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks… | Hohenstein Enterprises, Inc. | 2002 | — |
| 0 (this device) | K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR… | Synthes (USA) Products, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1995 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K051879 | Synthes (Usa) Porous Polyethylene ImplantsSummary page 6…ROUS POLYETHYLENE IMPLANTS – MR Conditional Classification Name(s): Surgical Mesh Regulatory Class: Class II; 878.3300 Product Code(s): FTM 1.3. Predicate Devices K051879 – Synthes Porous Polythylene Implants K040364 - Medpor Craniofacial Implants with Embedded Titanium K952677 - Medpor Barrier Surg… | 2005 |
| * | K040364 | Medpor Craniofacial Implants with Embedded Titanium MeshSummary page 6…lassification Name(s): Surgical Mesh Regulatory Class: Class II; 878.3300 Product Code(s): FTM 1.3. Predicate Devices K051879 – Synthes Porous Polythylene Implants K040364 - Medpor Craniofacial Implants with Embedded Titanium K952677 - Medpor Barrier Surgical Implant Biomaterial K832283 - Medpor Surg… | 2004 |
| * | K952677 | Medpor Barrier Surgical Implant BiomaterialSummary page 6…II; 878.3300 Product Code(s): FTM 1.3. Predicate Devices K051879 – Synthes Porous Polythylene Implants K040364 - Medpor Craniofacial Implants with Embedded Titanium K952677 - Medpor Barrier Surgical Implant Biomaterial K832283 - Medpor Surgical Implants K022665 - ePor Porous HDPE Surgical Implants 1… | 1995 |
| * | K832283 | Medpar Surgical ImplantsSummary page 6…evices K051879 – Synthes Porous Polythylene Implants K040364 - Medpor Craniofacial Implants with Embedded Titanium K952677 - Medpor Barrier Surgical Implant Biomaterial K832283 - Medpor Surgical Implants K022665 - ePor Porous HDPE Surgical Implants 1.4. Device Description The DePuy Synthes Porous Pol… | 1984 |
| * | K022665 | Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including…Summary page 6…lythylene Implants K040364 - Medpor Craniofacial Implants with Embedded Titanium K952677 - Medpor Barrier Surgical Implant Biomaterial K832283 - Medpor Surgical Implants K022665 - ePor Porous HDPE Surgical Implants 1.4. Device Description The DePuy Synthes Porous Polyethylene Implants consist of porou… | 2002 |
| * | K041333 | Synthes (Usa) Titanium WireSummary page 8…ion Name(s): Suture, Nonabsorbable, Steel, Monofilament and Multifilament, Sterile Regulatory Class: Class II; 878.4495 Product Code(s): GAQ 1.3. Predicate Devices K041333 - Synthes Titanium Wire Ethilon™ Nylon Suture 1.4. Device Description The DePuy Synthes Titanium Wire is a nonabsorbable, mon… | 2004 |
| * | K042606 | Modification to:Synthes (Usa) Titanium WireSummary page 10…ion Name(s): Suture, Nonabsorbable, Steel, Monofilament and Multifilament, Sterile Regulatory Class: Class II; 878.4495 Product Code(s): GAQ 1.3. Predicate Devices K042606 – Synthes Titanium Wire K041333 – Synthes Titanium Wire 1.4. Device Description The DePuy Synthes Titanium Wire with Barb is… | 2005 |
| * | — | Ethilon™ Nylon Suture Named without a submission number |
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 27 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- 3 of the 8 ancestors have a recall of any class.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
The DePuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
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/K183472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183472: DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183472
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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