510(k) Report

510(k) · Cleared

Cleared

Easy-Graft

K131385510(k) TraditionalCleared Sep 27, 2013136-day reviewClass II21 CFR 872.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Degradable Solutions AG · LYC Bone Grafting Material, Synthetic

Cleared on Sep 27, 2013 as substantially equivalent to K042583 (Ultradent Products, Inc., 2005) and 9 other predicates after a 136-day review. Its family tree reaches back 6 generations to 1996.

Decided
Sep 27, 2013
Review
136 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
10

Its longest line of descent runs back 6 generations to K954479 (1996). 39 ancestors in all, the oldest P800035 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2005: 2 other ancestors2004: 7 other ancestors1998: 4 other ancestors1996: 4 other ancestors1995: 5 other ancestors1999: 1 other ancestor1997: 1 other ancestor1981: 1 other ancestor2000: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor2001: 1 other ancestorK954479 · Dicomview · Heartlab, Inc. · 1996K972229 · Imageview Coronary Angiography Display and Review System · Heartware, Inc. · 1997K994210 · Inturis Suite · Philips Medical Systems, Inc. · 2000K022788 · Philips Harmony Release 1 · Philips Medical Systems North America Co. · 2002 · recalledK061995 · Xcelera · Philips Medical Systems North America Co. · 2006K103815 · Q-Station · Philips Ultrasound, Inc. · 201119801985199019952000200520102015
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 8 other ancestors3 generations back: 10 other ancestors4 generations back: 4 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor K103815 · Q-Station · Philips Ultrasound, Inc. · 2011K061995 · Xcelera · Philips Medical Systems North America Co. · 2006K022788 · Philips Harmony Release 1 · Philips Medical Systems North America Co. · 2002 · recalledK994210 · Inturis Suite · Philips Medical Systems, Inc. · 2000K972229 · Imageview Coronary Angiography Display and Review System · Heartware, Inc. · 1997K954479 · Dicomview · Heartlab, Inc. · 1996−50
  1. Root · 6 generations backK954479 DicomviewHeartlab, Inc. · 1996
  2. 5 generations backK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
  3. 4 generations backK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
  4. 3 generations backK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · Recalled
  5. 2 generations backK061995 XceleraPhilips Medical Systems North America Co. · 2006
  6. 1 generation backK103815 Q-StationPhilips Ultrasound, Inc. · 2011
  7. This deviceK131385 Easy-GraftDegradable Solutions AG · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K954479DicomviewHeartlab, Inc.1996—
−5K972229Imageview Coronary Angiography Display and Review SystemHeartware, Inc.1997—
−4K994210Inturis SuitePhilips Medical Systems, Inc.2000—
−3K022788Philips Harmony Release 1Philips Medical Systems North America Co.20022
−2K061995XceleraPhilips Medical Systems North America Co.2006—
−1K103815Q-StationPhilips Ultrasound, Inc.2011—
0 (this device)K131385Easy-GraftDegradable Solutions AG2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198510
198710
199210
199310
199550
199640
199710
199840
199910
200020
200110
200470
200520
200810
FIG. 1 — Lineage of K131385, 1996–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K042583Calc-I-Oss
Summary page 2
…ne Technological Characteristics Summary Comparison to Predicate Devices The predicate devices of easy-graftTh are: " calc-i-ossTm bone graft substitutes (K042583) ("calc-i-oss"), " CerasorbP M Dental and Cerasorbe Perio (KO051443) ("Cerasorb"), " Bio-Oss®, Bio-Oss® Blocks and…
Ultradent Products, Inc.2005—
*K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio
Summary page 2
…ices The predicate devices of easy-graftTh are: " calc-i-ossTm bone graft substitutes (K042583) ("calc-i-oss"), " CerasorbP M Dental and Cerasorbe Perio (KO051443) ("Cerasorb"), " Bio-Oss®, Bio-Oss® Blocks and Bio-Oss® Collagen (K952618 / K<970321 1033815)…
Curasan Ag, Frankfurt Facility2005—
*K952618Bio-Oss
Summary page 2
…substitutes (K042583) ("calc-i-oss"), " CerasorbP M Dental and Cerasorbe Perio (KO051443) ("Cerasorb"), " Bio-Oss®, Bio-Oss® Blocks and Bio-Oss® Collagen (K952618 / K<970321 1033815) K ("Bio…
Geistlich-Pharma1995—
*K970321Bio-Oss Anorganic Bovine Bone
Summary page 2
…(K042583) ("calc-i-oss"), " CerasorbP M Dental and Cerasorbe Perio (KO051443) ("Cerasorb"), " Bio-Oss®, Bio-Oss® Blocks and Bio-Oss® Collagen (K952618 / K<970321 1033815) K ("Bio-Oss"), ==…
Geistlich-Pharma1998—
*K103815Q-StationPhilips Ultrasound, Inc.2011—
*K041324Calmatrix Calcium Sulfate Bone Graft Binder
Summary page 3
…510(k) Submission Traditional Premarket Notification [510(k)] Page 3 Degradable Solutions AG " CalMatriX TM (K041324) ("Cal Matrix"), * Fortoss6 Vital (K082383) ("Fortoss Vital") " Atrisorbs Bioabsorbable Guided Tissue Regeneration (GTR)…
Lifecore Biomedical, Inc.2004—
*K082383Fortoss Vital
Summary page 3
…fication [510(k)] Page 3 Degradable Solutions AG " CalMatriX TM (K041324) ("Cal Matrix"), * Fortoss6 Vital (K082383) ("Fortoss Vital") " Atrisorbs Bioabsorbable Guided Tissue Regeneration (GTR) Barrier (K955838/ K982865) ("Atrisorb") a…
Biocomposites, Ltd.2008—
*K955838Atrisorb Bioabsorbable Guided Tissue Regneration (GTR)
Summary page 3
…AG " CalMatriX TM (K041324) ("Cal Matrix"), * Fortoss6 Vital (K082383) ("Fortoss Vital") " Atrisorbs Bioabsorbable Guided Tissue Regeneration (GTR) Barrier (K955838/ K982865) ("Atrisorb") and the " Inion GTRTh Biodegradable Membrane System (K033074) ("Inion Membrane"). Pred…
Atrix Laboratories, Inc.1996—
*K982865Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit
Summary page 3
…triX TM (K041324) ("Cal Matrix"), * Fortoss6 Vital (K082383) ("Fortoss Vital") " Atrisorbs Bioabsorbable Guided Tissue Regeneration (GTR) Barrier (K955838/ K982865) ("Atrisorb") and the " Inion GTRTh Biodegradable Membrane System (K033074) ("Inion Membrane"). Predicate Device Co…
Atrix Laboratories, Inc.19981
*K033074Inion GTR Biodegradable Membrane System
Summary page 3
…l") " Atrisorbs Bioabsorbable Guided Tissue Regeneration (GTR) Barrier (K955838/ K982865) ("Atrisorb") and the " Inion GTRTh Biodegradable Membrane System (K033074) ("Inion Membrane"). Predicate Device Comparison Table .Feature '. comparison Intended Use eas…
Inion, Ltd.20041

Also cleared against K042583: 1 other device →

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 6 companies; a new generation was cleared every 2.7 years on median.
  • 5 of the 39 ancestors have a recall of any class.
  • 1 other device also cites its predicate K042583.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

What is it indicated for?

easy-graft is indicated for the treatment of intraoral / maxillofacial osseous defects. Dental and maxillo-facial indications may include:

- Extraction defects (alveolar ridge preservation)

- Periodontal defects

- Peri-implant defects

- Augmentation of deficient alveolar crest (e.g. Guided Bone Regeneration, GBR)

- Sinus floor augmentation

- Defects after surgical extractions

- Defects after removal of bone cysts

- Defects after root resection or apicoectomy

- Defects after removal of autologous bone

Indications for use as stated in the FDA summary.

Also cleared against K042583

1 other device cites the same predicate.

  • K062102OdoncerTeknimed, S.A. · 2007

Recent decisions in LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K131385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131385: Easy-Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131385

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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