510(k) Report

510(k) · Cleared

Cleared

Bio-Oss Collagen

K974399510(k) TraditionalCleared Sep 16, 1998299-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

Geistlich-Pharma · LYC Bone Grafting Material, Synthetic

Cleared on Sep 16, 1998 after a 299-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 172 later devices descend from it.

Decided
Sep 16, 1998
Review
299 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
0

172 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2004: 5 descendants cleared2011: 10 descendants cleared2005: 5 descendants cleared2010: 11 descendants cleared2001: 1 descendant cleared2013: 4 descendants cleared2008: 10 descendants cleared2007: 8 descendants cleared2006: 5 descendants cleared2015: 5 descendants cleared2009: 9 descendants cleared2017: 11 descendants cleared2014: 7 descendants cleared2021: 5 descendants cleared2012: 6 descendants cleared2020: 11 descendants cleared2024: 13 descendants cleared2019: 5 descendants cleared2018: 6 descendants cleared2025: 11 descendants cleared2023: 12 descendants cleared2026: 4 descendants cleared2016: 1 descendant cleared2022: 7 descendants cleared1995200020052010201520202025
  1. This deviceK974399 Bio-Oss CollagenGeistlich-Pharma · 1998
  2. Descendant · cites it directly · 124 of its ownK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
  3. Descendant · cites it directly · 84 of its ownK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
  4. Descendant · 2 generations on · 67 of its ownK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
  5. Descendant · 2 generations on · 59 of its ownK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
  6. Descendant · cites it directly · 55 of its ownK043034 Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · Recalled

Showing 5 of 172 descendants. See all descendants

Descendants cleared per year

2001: 12004: 52005: 52006: 52007: 82008: 102009: 92010: 112011: 102012: 62013: 42014: 72015: 52016: 12017: 112018: 62019: 52020: 112021: 52022: 72023: 122024: 132025: 112026: 4
2001high 13 (2024) · low 0 (2002)2026

Most influential descendants

Showing 5 of 172 · See all
  • K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004 · cites it directly124descendants
  • K012751Healos Bone Graft MaterialOrquest, Inc. · 2001 · cites it directly84descendants
  • K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005 · 2 generations on67descendants
  • K051386Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005 · 2 generations on59descendants
  • K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · cites it directly55descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974399Bio-Oss CollagenGeistlich-Pharma1998—
+1K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma2004—
+1K012751Healos Bone Graft MaterialOrquest, Inc.2001—
+2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.2005—
+2K051386Mastergraft Putty Bone Void FillerMedtronic Vascular2005—
+1K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc.20053

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200450
200550
200650
200780
2008100
200990
2010110
2011100
201260
201340
201470
201550
201610
2017110
201860
201950
2020110
202150
202270
2023120
2024130
2025110
202640
FIG. 1 — Lineage of K974399, 1998–2026Source: 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 510(k) statement (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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (172)

See all 172

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma2004124
K012751Healos Bone Graft MaterialOrquest, Inc.200184
K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc.200555
K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454
K092428Bio-Oss CollagenEd. Geistlich Soehne AG Fuer Chemische Industrie201029
K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG201123
K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG201321
K112575Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG201111
K042706Ossatura DentalIsotis Orthobiologics, Inc.20046
K040783FoundationTerumo Corp.20043

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?

  • Of its descendants, K033815 (Geistlich-Pharma, 2004) has gone furthest, with 124 descendants of its own.

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.

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?

Augmentation or reconstructive treatment of alveolar ridge

Filling of periodontal defects

Filling of defects after root resection, apicoectomy, and cystectomy

Filling of extraction sockets to enhance preservation of the alveolar ridge

Elevation of maxillary sinus floor

Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration(GTR) and Guided Bone Regeneration (GBR)

Filling of peri-implant defects in-conjunction with. products intended for Guided Bone Regeneration (GBR)

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Geistlich-Pharma

16 FDA decisions under this applicant name. See the company

  • K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
  • K014289Orthoss Resorbable Bone Void FillerGeistlich-Pharma · 2002
  • K970569Bio-BlocksGeistlich-Pharma · 2000
  • K970321Bio-Oss Anorganic Bovine BoneGeistlich-Pharma · 1998
  • K972817Resor-Pin Resorbable Membrane PinGeistlich-Pharma · 1998

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/K974399 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974399: Bio-Oss Collagen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974399

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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