510(k) · Cleared
ClearedMedpor Contain Can Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Surgical, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on Jan 7, 2011 as substantially equivalent to K091120 (Porex Surgical, Inc., 2010) after a 158-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jan 7, 2011
- Review
- 158 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922627 (1994). 18 ancestors in all, the oldest K862482 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK922627 Gore-Tex Regenerative MaterialW. L. Gore & Associates, Inc. · 1994
- 3 generations backK964342 Cytoplast GBROsteogenics Co. · 1997
- 2 generations backK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · Recalled
- 1 generation backK091120 Medpor Contain ImplantPorex Surgical, Inc. · 2010
- This deviceK102184 Medpor Contain Can ImplantPorex Surgical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922627 | Gore-Tex Regenerative Material | W. L. Gore & Associates, Inc. | 1994 | — |
| −3 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| −2 | K972278 | Cytoplast Regentex Titanium 250 | Osteogenics Co. | 1997 | 1 |
| −1 | K091120 | Medpor Contain Implant | Porex Surgical, Inc. | 2010 | — |
| 0 (this device) | K102184 | Medpor Contain Can Implant | Porex Surgical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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 NPK? 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 NPK device
- #1 K221851 Lumina-PTFE Titaniumscore 7.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K091120 | Medpor Contain ImplantSummary page 1…ant Descriptive Name: MEDPOR CONTAIN Implant Classification: 11, 21 CER 872.3930 - Bone grafting material Product Code: NPK Predicate Device: MEDPOR CONTAIN Implant (K091 120) Device Description: The purpose of this Special 510(k) is to add the CAN configuration to MEDPOR CONTAIN implants. Tfhe MEDPOR… | 2010 |
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 17 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 18 ancestors have a recall of any class.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NPK
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NPK
529in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPK
No recall names NPK since 2007.
Adverse event reports per year · NPK
3in 2022
MAUDE reports naming product code NPK, 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 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 529 | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MEDPOR CONTAIN CAN Implant is intended to stabilize,
support and provide space maintenance for bone graft materials in the maxilla, mandible
and zygoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102184: Medpor Contain Can Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102184
Report an extraction error
Are you the manufacturer?
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