510(k) · Cleared
ClearedAtrisorb-D Freeflow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrix Laboratories, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Sep 13, 2000 as substantially equivalent to K955838 (Atrix Laboratories, Inc., 1996) and 1 other predicate after a 281-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 13, 2000
- Review
- 281 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955838 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK955838 Atrisorb Bioabsorbable Guided Tissue Regneration (GTR)Atrix Laboratories, Inc. · 1996
- This deviceK994137 Atrisorb-D Freeflow Bioabsorbable Guided Tissue Regeneration (GTR)…Atrix Laboratories, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955838 | Atrisorb Bioabsorbable Guided Tissue Regneration (GTR) | Atrix Laboratories, Inc. | 1996 | — |
| 0 (this device) | K994137 | Atrisorb-D Freeflow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier… | Atrix Laboratories, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K955838 | Atrisorb Bioabsorbable Guided Tissue Regneration (GTR)Summary page 1…ioabsorbable Guided Tissue Regeneration Barrier with Doxycycline Bone Filling Augmentation Material K ATRISORB® Bioabsorbable Guided Tissue Regeneration (GTR) Barrier K955838 and K982865 The polymer formulation used in the ATRISORB®-D FreeFlow™ Bioabsorbable Guided Tissue Regeneration (GTR) Barrier wit… | 1996 |
| * | K982865 | Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier KitSummary page 1…Guided Tissue Regeneration Barrier with Doxycycline Bone Filling Augmentation Material K ATRISORB® Bioabsorbable Guided Tissue Regeneration (GTR) Barrier K955838 and K982865 The polymer formulation used in the ATRISORB®-D FreeFlow™ Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycyc… | 1998 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K955838.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
ATRISORB®-D FreeFlow™ Barrier is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. ATRISORB®-D FreeFlow™ Barrier has been shown to reduce bacterial colonization of the barrier.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994137 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994137: Atrisorb-D Freeflow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994137
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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