510(k) · Cleared
Recalled · Class II · 2019Omnipore Surgical Implants and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matrix Surgical USA · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Jul 31, 2013 as substantially equivalent to K922489 (Porex Technologies Corp., 1992) after a 224-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 31, 2013
- Review
- 224 days
- Class
- Class II
- Product code
- KKY
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922489 (1992). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- This deviceK123908 Omnipore Surgical Implants and AccessoriesMatrix Surgical USA · 2013
- Descendant · cites it directly · 2 of its ownK140437 SU-Por Surgical ImplantPoriferous, LLC · 2014
- Descendant · cites it directly · 0 of its ownK211514 Longeviti PorousFit implantLongeviti Neuro Solutions, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK160988 Biopor, AOC Porous Polyethylene, CereporCeremed, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK152463 SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific…Poriferous, LLC · 2016
- Descendant · cites it directly · 0 of its ownK133046 Omnipore Customized Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA · 2014 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K140437SU-Por Surgical ImplantPoriferous, LLC · 2014 · cites it directly2descendants
- K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLC · 2021 · cites it directly0descendants
- K160988Biopor, AOC Porous Polyethylene, CereporCeremed, Inc. · 2016 · 2 generations on0descendants
- K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC · 2016 · 2 generations on0descendants
- K133046Omnipore Customized Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| 0 (this device) | K123908 | Omnipore Surgical Implants and Accessories | Matrix Surgical USA | 2013 | — |
| +1 | K140437 | SU-Por Surgical Implant | Poriferous, LLC | 2014 | — |
| +1 | K211514 | Longeviti PorousFit implant | Longeviti Neuro Solutions, LLC | 2021 | — |
| +2 | K160988 | Biopor, AOC Porous Polyethylene, Cerepor | Ceremed, Inc. | 2016 | — |
| +2 | K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | 2016 | — |
| +1 | K133046 | Omnipore Customized Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2021 | 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 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? (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 |
|---|---|---|---|
| * | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac ImplaSummary page 1…ces: POREX Surgical Inc. (now owned by Stryker" Craniomaxillofacial) - MEOPOR® Surgical Implant Material: Preformed Cranial and Facial Implants - 510(k) # K922489 Device Description: The OmniPore® Surgical Implants are marketed as single use sterile implants with various shapes and… | 1992 |
What descends from it? (5)
3 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 |
|---|---|---|---|---|
| Jan 30, 2019 | Class II | Z-1223-2019 | Employee error | Product mislabeling. |
| Jan 30, 2019 | Class II | Z-1224-2019 | Employee error | Product mislabeling. |
| Jan 25, 2017 | Class II | Z-1382-2017 | Other | Mislabeling. The packaging labeled as left mandible contained a right mandible. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2013, 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?
OmniPore® Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore 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/K123908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123908: Omnipore Surgical Implants and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123908
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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