510(k) Report

510(k) · Cleared

Cleared

Bio-Oss Anorganic Bovine Bone

K970321510(k) TraditionalCleared Sep 15, 1998595-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 15, 1998 after a 595-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 296 later devices descend from it.

Decided
Sep 15, 1998
Review
595 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 5 descendants cleared2011: 13 descendants cleared1999: 1 descendant cleared2005: 5 descendants cleared2013: 7 descendants cleared2014: 13 descendants cleared2015: 9 descendants cleared2010: 13 descendants cleared2008: 15 descendants cleared2017: 13 descendants cleared2021: 13 descendants cleared2012: 7 descendants cleared2020: 11 descendants cleared2025: 27 descendants cleared2009: 13 descendants cleared2007: 10 descendants cleared2006: 6 descendants cleared2019: 12 descendants cleared2018: 14 descendants cleared2024: 26 descendants cleared2023: 23 descendants cleared2026: 17 descendants cleared2003: 3 descendants cleared2016: 5 descendants cleared2022: 15 descendants cleared1995200020052010201520202025
  1. This deviceK970321 Bio-Oss Anorganic Bovine BoneGeistlich-Pharma · 1998
  2. Descendant · cites it directly · 189 of its ownK992416 Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1999
  3. Descendant · cites it directly · 124 of its ownK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
  4. Descendant · 2 generations on · 85 of its ownK033994 Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
  5. Descendant · 3 generations on · 84 of its ownK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
  6. Descendant · 2 generations on · 80 of its ownK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004

Showing 5 of 296 descendants. See all descendants

Descendants cleared per year

1999: 12003: 32004: 52005: 52006: 62007: 102008: 152009: 132010: 132011: 132012: 72013: 72014: 132015: 92016: 52017: 132018: 142019: 122020: 112021: 132022: 152023: 232024: 262025: 272026: 17
1999high 27 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 296 · See all
  • K992416Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1999 · cites it directly189descendants
  • K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004 · cites it directly124descendants
  • K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · 2 generations on85descendants
  • K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · 3 generations on84descendants
  • K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004 · 2 generations on80descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970321Bio-Oss Anorganic Bovine BoneGeistlich-Pharma1998—
+1K992416Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp.1999—
+1K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma2004—
+2K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC2004—
+3K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC2004—
+2K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200330
200450
200550
200660
2007100
2008150
2009130
2010130
2011130
201270
201370
2014130
201590
201650
2017130
2018140
2019120
2020110
2021130
2022150
2023230
2024260
2025270
2026170
FIG. 1 — Lineage of K970321, 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? (296)

See all 296

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

NumberDeviceApplicantDecidedDescendants
K992416Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp.1999189
K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma2004124
K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG201123
K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG201321
K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility200518
K040501DBX Demineralized Bone Matrix Putty, Paste and MixMusculoskeletal Transplant Foundation20053
K040646Straumann GranulesThe Straumann Co.20042
K113246OCS-BNibec Company, Limited20131
K111816EquimatrixLuitpold Pharmaceuticals, Inc.20111
K151209InterOssSigmagraft, Inc.20150

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, K992416 (Usbiomaterials Corp., 1999) has gone furthest, with 189 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

Treatment of defects after root resection, apicoectomy, and cystectomy

Filling of extraction sockets to enhance preservation of 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
  • K974399Bio-Oss CollagenGeistlich-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/K970321 · printed Nov 3, 2026

Cite this page

510(k) Report. “K970321: Bio-Oss Anorganic Bovine Bone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970321

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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