510(k) · Cleared

Cleared

Conduit TCP Granules

K014053510(k) TraditionalCleared Mar 8, 200288-day reviewClass II21 CFR 888.3045

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

Depuyacromed · MQV Filler, Bone Void, Calcium Compound

Cleared on Mar 8, 2002 as substantially equivalent to K994337 (Orthovita Co., 2000) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1999. 7 later devices descend from it.

Decided: Mar 8, 2002
Review: 88 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K990131 (1999). 2 ancestors in all. 7 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
This deviceK014053 Conduit TCP GranulesDepuyacromed · 2002
Descendant · cites it directly · 3 of its ownK030178 Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003
Descendant · cites it directly · 1 of its ownK050357 Camceram TCPCam Implants B.V. · 2005
Descendant · 2 generations on · 1 of its ownK032286 Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc. · 2003
Descendant · 2 generations on · 0 of its ownK102937 Osteophil Beta-TCPCytophil, Inc. · 2010
Descendant · 3 generations on · 0 of its ownK063346 Pro Osteon 500REbi, L.P. · 2007

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003high 3 (2005) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all

K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003 · cites it directly3descendants
K050357Camceram TCPCam Implants B.V. · 2005 · cites it directly1descendant
K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc. · 2003 · 2 generations on1descendant
K102937Osteophil Beta-TCPCytophil, Inc. · 2010 · 2 generations on0descendants
K063346Pro Osteon 500REbi, L.P. · 2007 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990131	Pro Osteon Implant 500R Resorbable Bone Graft Substitute	Interpore Cross Intl.	1999	—
0 (this device)	K014053	Conduit TCP Granules	Depuyacromed	2002	—
+1	K030178	Calcigen Psi Bone Graft Substitute	Biomet, Inc.	2003	—
+1	K050357	Camceram TCP	Cam Implants B.V.	2005	—
+2	K032286	Calcigen Psi Bone Graft Substitute	Biomet Orthopedics, Inc.	2003	—
+2	K102937	Osteophil Beta-TCP	Cytophil, Inc.	2010	—
+3	K063346	Pro Osteon 500R	Ebi, L.P.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2005	3	0
2007	1	0
2010	1	0

FIG. 1 — Lineage of K014053, 1999–2010Source: 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 MQV? 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 MQV device

#1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K994337	Vitoss Scaffold Synthetic Cancellous Bone Void Filler Summary page 1 …mount Drive Raynham, MA 02767-0350 USA Karen F. Jurczak December 07, 2001 Conduit™ TCP Granules Bone Graft Substitute Material, Bone Void Filler & Orthovita VITOSS (K994337) 4 Pro Osteon 500R Resorbable Bone Graft Substitute (K990131) The Conduit™ TCP Granules are indicated for filling bone voids or…	Orthovita Co.	2000	—
*	K990131	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Summary page 1 …mber 07, 2001 Conduit™ TCP Granules Bone Graft Substitute Material, Bone Void Filler & Orthovita VITOSS (K994337) 4 Pro Osteon 500R Resorbable Bone Graft Substitute (K990131) The Conduit™ TCP Granules are indicated for filling bone voids or defects of the skeletal system (such as the extremities, spin…	Interpore Cross Intl.	1999	—

Also cleared against K994337: 25 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K030178	Calcigen Psi Bone Graft Substitute	Biomet, Inc.	2003	3
K050357	Camceram TCP	Cam Implants B.V.	2005	1
K051775	Osteomimetic Synthetic Bone Matrix	Biomimetic Pharmaceuticals, Inc.	2005	0

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 2 ancestors has a recall.
Of its descendants, K030178 (Biomet, Inc., 2003) has gone furthest, with 3 descendants of its own.
25 other devices also cite its predicate K994337.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQV

14in 2025

2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007high 214 (2016) · low 55 (2024)2026

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

Recalls per year · MQV

1in 2025

2007high 6 (2011) · low 0 (2010)2026

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

Adverse event reports per year · MQV

57in 2025

2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, 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	35	144	5	67
2008	32	102	3	71
2009	23	180	1	81
2010	17	147	0	68
2011	16	92	6	114
2012	9	107	3	149
2013	12	197	2	223
2014	20	153	0	111
2015	18	184	0	125
2016	8	214	1	106
2017	17	124	1	107
2018	23	124	2	86
2019	13	90	0	65
2020	15	132	1	126
2021	8	88	0	101
2022	9	118	0	47
2023	21	74	3	120
2024	28	55	2	68
2025	14	57	1	57
2026	5	96	4	—

What is it indicated for?

The Conduit™ TCP Granules are indicated for filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Conduit™ TCP Granules is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014053 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014053: Conduit TCP Granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014053

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026