510(k) Report

510(k) · Cleared

Cleared

Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen

K033815510(k) TraditionalCleared Jan 15, 200437-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 · NPM Bone Grafting Material, Animal Source

Cleared on Jan 15, 2004 as substantially equivalent to K871773 (Geistlich-Pharma, 1987) and 6 other predicates after a 37-day review. Its family tree reaches back 1 generation to 1987. 124 later devices descend from it.

Decided
Jan 15, 2004
Review
37 days
Class
Class II
Product code
NPM
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K871773 (1987). 7 ancestors in all. 124 later devices descend from it, 18 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 2 other ancestors1995: 2 other ancestors1992: 1 other ancestor2011: 8 descendants cleared2010: 10 descendants cleared2005: 2 descendants cleared2008: 6 descendants cleared2017: 7 descendants cleared2014: 5 descendants cleared2021: 5 descendants cleared2013: 4 descendants cleared2012: 5 descendants cleared2009: 5 descendants cleared2006: 2 descendants cleared2007: 3 descendants cleared2024: 11 descendants cleared2025: 10 descendants cleared2019: 5 descendants cleared2018: 6 descendants cleared2015: 3 descendants cleared2022: 7 descendants cleared2023: 9 descendants cleared2020: 8 descendants cleared2026: 3 descendants clearedK871773 · Bio-Oss Pure Nat Hydroxyapatite Endoss Implant · Geistlich-Pharma · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 18 descendants2 generations forward: 46 descendants3 generations forward: 15 descendants4 generations forward: 14 descendants5 generations forward: 18 descendants6 generations forward: 9 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K871773 · Bio-Oss Pure Nat Hydroxyapatite Endoss Implant · Geistlich-Pharma · 19870+5
  1. Root · 1 generation backK871773 Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma · 1987
  2. This deviceK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
  3. Descendant · cites it directly · 55 of its ownK043034 Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 40 of its ownK052812 Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006
  5. Descendant · 3 generations on · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
  6. Descendant · 4 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
  7. Descendant · cites it directly · 29 of its ownK092428 Bio-Oss CollagenEd. Geistlich Soehne AG Fuer Chemische Industrie · 2010

Showing 5 of 124 descendants. See all descendants

Descendants cleared per year

2005: 22006: 22007: 32008: 62009: 52010: 102011: 82012: 52013: 42014: 52015: 32017: 72018: 62019: 52020: 82021: 52022: 72023: 92024: 112025: 102026: 3
2005high 11 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 124 · See all
  • K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · cites it directly55descendants
  • K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006 · 2 generations on40descendants
  • K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 3 generations on38descendants
  • K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 4 generations on30descendants
  • K092428Bio-Oss CollagenEd. Geistlich Soehne AG Fuer Chemische Industrie · 2010 · cites it directly29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K871773Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma1987—
0 (this device)K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma2004—
+1K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc.20053
+2K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.2006—
+3K082166Mastergraft StripMedtronic Sofamor Danek2009—
+4K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.2014—
+1K092428Bio-Oss CollagenEd. Geistlich Soehne AG Fuer Chemische Industrie2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199520
199820
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200620
200730
200860
200950
2010100
201180
201250
201340
201450
201530
201770
201860
201950
202080
202150
202270
202390
2024110
2025100
202630
FIG. 1 — Lineage of K033815, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 NPM? 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 NPM device

  1. #1 K240661 Geistlich Bio-Oss®score 15.2 · 6 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? (7)

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
*K871773Bio-Oss Pure Nat Hydroxyapatite Endoss Implant
Summary page 1
…mmon/Usual Name: Anorganic Bovine Bone Filling Material Classification Name: Bone Filling Material 3. PREDICATE DEVICES BIG-OSS® (K87 1773, K9526 17, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS®V Collagen (K974399) 4. INTEN…
Geistlich-Pharma1987—
*K952617Bio-Oss
Summary page 1
…Name: Anorganic Bovine Bone Filling Material Classification Name: Bone Filling Material 3. PREDICATE DEVICES BIG-OSS® (K87 1773, K9526 17, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS®V Collagen (K974399) 4. INTENDED USE…
Geistlich-Pharma1995—
*K970321Bio-Oss Anorganic Bovine Bone
Summary page 1
…Anorganic Bovine Bone Filling Material Classification Name: Bone Filling Material 3. PREDICATE DEVICES BIG-OSS® (K87 1773, K9526 17, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS®V Collagen (K974399) 4. INTENDED USE BIO-OSS…
Geistlich-Pharma1998—
*K920508Bio-Oss Blocks
Summary page 1
…Material Classification Name: Bone Filling Material 3. PREDICATE DEVICES BIG-OSS® (K87 1773, K9526 17, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS®V Collagen (K974399) 4. INTENDED USE BIO-OSS®, BIO-OSS Blocks and BIG0-OSS® C…
Geistlich-Pharma1992—
*K952618Bio-Oss
Summary page 1
…Classification Name: Bone Filling Material 3. PREDICATE DEVICES BIG-OSS® (K87 1773, K9526 17, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS®V Collagen (K974399) 4. INTENDED USE BIO-OSS®, BIO-OSS Blocks and BIG0-OSS® Collagen a…
Geistlich-Pharma1995—
*K970569Bio-Blocks
Summary page 1
…ification Name: Bone Filling Material 3. PREDICATE DEVICES BIG-OSS® (K87 1773, K9526 17, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS®V Collagen (K974399) 4. INTENDED USE BIO-OSS®, BIO-OSS Blocks and BIG0-OSS® Collagen are recommende…
Geistlich-Pharma2000—
*K974399Bio-Oss Collagen
Summary page 1
…g Material 3. PREDICATE DEVICES BIG-OSS® (K87 1773, K9526 17, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS®V Collagen (K974399) 4. INTENDED USE BIO-OSS®, BIO-OSS Blocks and BIG0-OSS® Collagen are recommended for: * Filling of lar…
Geistlich-Pharma1998—

Also cleared against K871773: 3 other devices →

What descends from it? (124)

See all 124

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

NumberDeviceApplicantDecidedDescendants
K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc.200555
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
K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility200518
K112575Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG201111
K090401OrthossEd. Geistlich Soehne AG Fur Chemische Industrie20103
K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083
K073571Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation20082
K113246OCS-BNibec Company, Limited20131

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?

  • None of the 7 ancestors has a recall.
  • Of its descendants, K043034 (Collagen Matrix, Inc., 2005) has gone furthest, with 55 descendants of its own.
  • 3 other devices also cite its predicate K871773.

How does its category compare?

All NPM devices

NPM Bone Grafting Material, Animal Source: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NPM

3in 2025

2009: 12010: 22011: 32012: 22013: 22014: 22015: 42016: 12017: 52018: 22020: 32021: 22023: 22024: 32025: 32026 (partial year): 3
2007high 5 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NPM

30in 2025

2011: 112 days median2015: 349 days median2017: 191 days median2020: 231 days median2024: 211 days median2025: 30 days median2026 (partial year): 269 days median
2007high 349 (2015) · low 30 (2025)2026

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

Recalls per year · NPM

1in 2022

2018: 12020: 32022: 1
2007high 3 (2020) · low 0 (2007)2026

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

Adverse event reports per year · NPM

14in 2025

2007: 12010: 12012: 22013: 32014: 32015: 12016: 12017: 32018: 82019: 62020: 32021: 42022: 272023: 42024: 52025: 14
2007high 27 (2022) · low 0 (2008)2025

MAUDE reports naming product code NPM, 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
20070—01
20080—00
20091—00
20102—01
2011311200
20122—02
20132—03
20142—03
2015434901
20161—01
2017519103
20182—18
20190—06
2020323133
20212—04
20220—127
20232—04
2024321105
2025330014
202632690—

What is it indicated for?

Augmentation or reconstructive treatment of alveolar ridge

Filling of periodontal defects

Filing of defects after root resection, apicoectomy, and cystectomy

Filing 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).

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

Indications for use as stated in the FDA summary.

Also cleared against K871773

3 other devices cite the same predicate.

  • K123876SynergyOdontit S.A. · 2014
  • K113246OCS-BNibec Company, Limited · 2013
  • K111816EquimatrixLuitpold Pharmaceuticals, Inc. · 2011

More from Geistlich-Pharma

16 FDA decisions under this applicant name. See the company

  • K014289Orthoss Resorbable Bone Void FillerGeistlich-Pharma · 2002
  • K970569Bio-BlocksGeistlich-Pharma · 2000
  • K974399Bio-Oss CollagenGeistlich-Pharma · 1998
  • K970321Bio-Oss Anorganic Bovine BoneGeistlich-Pharma · 1998
  • K972817Resor-Pin Resorbable Membrane PinGeistlich-Pharma · 1998

Recent decisions in NPM

The NPM category page

  • K260096Wishbone HAEWishbone SA · 2026
  • K254210Rebohil (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)Hyundai Bioland Co., Ltd. · 2026
  • K253723BOSSMedpark Co., Ltd. · 2026
  • K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG · 2025
  • K251613SwissGraft XGeistlich Pharma AG · 2025

https://510kreport.com/device/K033815 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033815: Bio-Oss, Bio-Oss Blocks and 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/K033815

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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