510(k) · Cleared
ClearedAdaptain, Adaptain Fastwrap, Envelock, Biowai
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceremed, Inc. · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Sep 12, 2013 as substantially equivalent to K122561 (Ceremed, Inc., 2012) after a 58-day review. Its family tree reaches back 9 generations to 1979.
- Decided
- Sep 12, 2013
- Review
- 58 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K791495 (1979). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 5 generations between
- 3 generations backK081531 Aoc Soluble Implant MaterialCeremed, Inc. · 2008
- 2 generations backK120220 Adaptain Soluble Implant MaterialCeremed, Inc. · 2012
- 1 generation backK122561 Adaptain Fastwrap, Envelock, GraftainCeremed, Inc. · 2012
- This deviceK132198 Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc. · 2013
Show all 9 generations
- Root · 9 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 8 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 7 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 6 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 5 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- 4 generations backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- 3 generations backK081531 Aoc Soluble Implant MaterialCeremed, Inc. · 2008
- 2 generations backK120220 Adaptain Soluble Implant MaterialCeremed, Inc. · 2012
- 1 generation backK122561 Adaptain Fastwrap, Envelock, GraftainCeremed, Inc. · 2012
- This deviceK132198 Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −8 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −7 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −6 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −5 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| −4 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| −3 | K081531 | Aoc Soluble Implant Material | Ceremed, Inc. | 2008 | — |
| −2 | K120220 | Adaptain Soluble Implant Material | Ceremed, Inc. | 2012 | — |
| −1 | K122561 | Adaptain Fastwrap, Envelock, Graftain | Ceremed, Inc. | 2012 | — |
| 0 (this device) | K132198 | Adaptain, Adaptain Fastwrap, Envelock, Biowai | Ceremed, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K122561 | Adaptain Fastwrap, Envelock, GraftainSummary page 2…sign, materials, indications, performance and sterilization to the predicate Adaptain FastWrap " (K122561). ....... DEPARTMIENT 'OF hEALI'11&1HUMAN SERV'ICES Pbi ~~il… | 2012 |
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 34 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 15 ancestors have a recall of any class.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Adaptain is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132198: Adaptain, Adaptain Fastwrap, Envelock, Biowai.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132198
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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