510(k) · Cleared
ClearedBiopor, AOC Porous Polyethylene, Cerepor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceremed, Inc. · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Jul 14, 2016 as substantially equivalent to K141880 (Ceremed, Inc., 2015) and 2 other predicates after a 97-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jul 14, 2016
- Review
- 97 days
- Class
- Class II
- Product code
- KKY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K922489 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 2 generations backK123908 Omnipore Surgical Implants and AccessoriesMatrix Surgical USA · 2013 · Recalled
- 1 generation backK140437 SU-Por Surgical ImplantPoriferous, LLC · 2014
- This deviceK160988 Biopor, AOC Porous Polyethylene, CereporCeremed, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −2 | K123908 | Omnipore Surgical Implants and Accessories | Matrix Surgical USA | 2013 | 3 |
| −1 | K140437 | SU-Por Surgical Implant | Poriferous, LLC | 2014 | — |
| 0 (this device) | K160988 | Biopor, AOC Porous Polyethylene, Cerepor | Ceremed, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K141880 | Biopor Aoc Porous Polyethylene, CereporSummary page 4…KKY Predicate Devices: 1. Ceremed, Inc. Biopor® Porous Polyethylene Surgical Implants (K141880) 2. Poriferous, LLC Su-Por® Surgical Implants (K140437) 3. Stryker® (Form… | 2015 |
| * | K140437 | SU-Por Surgical ImplantSummary page 4…ed, Inc. Biopor® Porous Polyethylene Surgical Implants (K141880) 2. Poriferous, LLC Su-Por® Surgical Implants (K140437) 3. Stryker® (Formerly Porex) Medpor® Surgical Implant Material (K922489) Description o… | 2014 |
| * | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac ImplaSummary page 4…ferous, LLC Su-Por® Surgical Implants (K140437) 3. Stryker® (Formerly Porex) Medpor® Surgical Implant Material (K922489) Description of the device: Biopor® Porous Polyethylene Implants are manufactured of porous high-density polyethylene,… | 1992 |
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 24 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K141880.
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. 2016, 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?
Biopor Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160988: Biopor, AOC Porous Polyethylene, Cerepor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160988
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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