510(k) · Cleared

Cleared

Synergy

K123876510(k) TraditionalCleared May 22, 2014521-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

Odontit S.A. · NPM Bone Grafting Material, Animal Source

Cleared on May 22, 2014 as substantially equivalent to K871773 (Geistlich-Pharma, 1987) and 4 other predicates after a 521-day review. Its family tree reaches back 3 generations to 1987.

Decided: May 22, 2014
Review: 521 days
Class: Class II
Product code: NPM
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K871773 (1987). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK871773 Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma · 1987
2 generations backK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
1 generation backK111816 EquimatrixLuitpold Pharmaceuticals, Inc. · 2011
This deviceK123876 SynergyOdontit S.A. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K871773	Bio-Oss Pure Nat Hydroxyapatite Endoss Implant	Geistlich-Pharma	1987	—
−2	K033815	Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen	Geistlich-Pharma	2004	—
−1	K111816	Equimatrix	Luitpold Pharmaceuticals, Inc.	2011	—
0 (this device)	K123876	Synergy	Odontit S.A.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	2	0
1998	2	0
2000	1	0

FIG. 1 — Lineage of K123876, 1987–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K240661 Geistlich Bio-Oss®score 15.2 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K871773	Bio-Oss Pure Nat Hydroxyapatite Endoss Implant Summary page 1 …Bone Grafting Material, Animal Source 6. Predicate Devices: Device: Bio-Oss® natural bone grafting material 510 (k) Numbers: K871773, K952617,K1970321, K033815 Manufactured by: Geistlich Pharma AG Bahnhofstrasse 40…	Geistlich-Pharma	1987	—
*	K952617	Bio-Oss Summary page 1 …Grafting Material, Animal Source 6. Predicate Devices: Device: Bio-Oss® natural bone grafting material 510 (k) Numbers: K871773, K952617,K1970321, K033815 Manufactured by: Geistlich Pharma AG Bahnhofstrasse 40…	Geistlich-Pharma	1995	—
*	K970321	Bio-Oss Anorganic Bovine Bone Summary page 4 …_________ 510O(k) N/A K871773,1<952617,~ K111816 Number K970321, K03381.5 ________ Intended Use SYNERGY is Blo-Oss@ is EQUIMATRIXTM intende…	Geistlich-Pharma	1998	—
*	K033815	Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen Summary page 1 …Animal Source 6. Predicate Devices: Device: Bio-Oss® natural bone grafting material 510 (k) Numbers: K871773, K952617,K1970321, K033815 Manufactured by: Geistlich Pharma AG Bahnhofstrasse 40…	Geistlich-Pharma	2004	—
*	K111816	Equimatrix Summary page 4 …EQUIMATRIXTh Information _________ 510O(k) N/A K871773,1<952617,~ K111816 Number K970321, K03381.5 ________ Intended Use SYNERGY is Blo-Oss@ is…	Luitpold Pharmaceuticals, Inc.	2011	—

Also cleared against K871773: 3 other devices →

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 27 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
None of the 9 ancestors has a recall.
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. 2014, this device’s year, is highlighted.

FDA decisions per year · NPM

3in 2025

2007high 5 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NPM

30in 2025

2007high 349 (2015) · low 30 (2025)2026

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

Recalls per year · NPM

1in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	1
2008	0	—	0	0
2009	1	—	0	0
2010	2	—	0	1
2011	3	112	0	0
2012	2	—	0	2
2013	2	—	0	3
2014	2	—	0	3
2015	4	349	0	1
2016	1	—	0	1
2017	5	191	0	3
2018	2	—	1	8
2019	0	—	0	6
2020	3	231	3	3
2021	2	—	0	4
2022	0	—	1	27
2023	2	—	0	4
2024	3	211	0	5
2025	3	30	0	14
2026	3	269	0	—

What is it indicated for?

SYNERGY is intended for use in:

Augmentation or reconstructive treatment of alveolar ridge

Filling periodontal defects

Filling defects after root resection, apicoectomy, and cystectomy

Filling extraction sockets to enhance preservation of the alveolar ridge

Elevation of maxillary sinus floor

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

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123876 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123876: Synergy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123876

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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