510(k) · Cleared
ClearedSU-Por Surgical Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poriferous, LLC · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Jun 13, 2014 as substantially equivalent to K922489 (Porex Technologies Corp., 1992) and 1 other predicate after a 112-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Jun 13, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- KKY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922489 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 1 generation backK123908 Omnipore Surgical Implants and AccessoriesMatrix Surgical USA · 2013 · Recalled
- This deviceK140437 SU-Por Surgical ImplantPoriferous, LLC · 2014
- Descendant · cites it directly · 0 of its ownK160988 Biopor, AOC Porous Polyethylene, CereporCeremed, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK152463 SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific…Poriferous, LLC · 2016
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 |
|---|---|---|---|---|---|
| −2 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −1 | K123908 | Omnipore Surgical Implants and Accessories | Matrix Surgical USA | 2013 | 3 |
| 0 (this device) | K140437 | SU-Por Surgical Implant | Poriferous, LLC | 2014 | — |
| +1 | K160988 | Biopor, AOC Porous Polyethylene, Cerepor | Ceremed, Inc. | 2016 | — |
| +1 | K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 KKY? 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 KKY device
- #1 K211514 Longeviti PorousFit implantscore 2.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac ImplaSummary page 1…Devices: POREX Surgical INC. (now owned by Stryker®D Craniomaxillofacial) MEDPOR® Surgical Implant Material Preformed Cranial and Facial Implants - 510(k) # K922489 Matrix Surgical USA OmniPor@ Surgical Implants - 510(k) #K1 23908 REV C 06/13/2014 Poriferous, .LLC… | 1992 |
| * | K123908 | Omnipore Surgical Implants and AccessoriesSummary page 1…ofacial) MEDPOR® Surgical Implant Material Preformed Cranial and Facial Implants - 510(k) # K922489 Matrix Surgical USA OmniPor@ Surgical Implants - 510(k) #K1 23908 REV C 06/13/2014 Poriferous, .LLC K14 04 37 Office: 770-6… | 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)
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 22 years and passes through 3 companies; a new generation was cleared every 20.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K160988 (Ceremed, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K922489.
How does its category compare?
All KKY devicesKKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KKY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KKY
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KKY
1in 2025
MAUDE reports naming product code KKY, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 4 | 3 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 1 | — | 1 | 17 |
| 2014 | 3 | 224 | 0 | 9 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Su-Por Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing aplications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. Su-Por Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140437: SU-Por Surgical Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140437
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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