510(k) · Cleared

Cleared

TRS Cranial Bone Void Filler (TRS C-BVF)

K123633510(k) TraditionalCleared Aug 16, 2013266-day reviewClass II21 CFR 882.5250

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

Tissue Regeneration Systems, Inc. · GXR Cover, Burr Hole

Cleared on Aug 16, 2013 as substantially equivalent to K051093 (Osteopore, Inc., 2006) and 3 other predicates after a 266-day review. Its family tree reaches back 3 generations to 2002.

Decided: Aug 16, 2013
Review: 266 days
Class: Class II
Product code: GXR
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K013966 (2002). 9 ancestors in all, the oldest K003015 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
2 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
1 generation backK051093 Osteopore PCL ScaffoldOsteopore, Inc. · 2006 · Recalled
This deviceK123633 TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K013966	Apatight-TCP Bone Graft Substitute	Cerabio, LLC	2002	—
−2	K022629	WMT-TCP Bone Graft Substitute	Wrightmedicaltechnologyinc	2002	—
−1	K051093	Osteopore PCL Scaffold	Osteopore, Inc.	2006	1
0 (this device)	K123633	TRS Cranial Bone Void Filler (TRS C-BVF)	Tissue Regeneration Systems, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2004	2	0
2005	1	0
2007	1	0

FIG. 1 — Lineage of K123633, 2002–2013Source: 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 GXR? 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 GXR device

#1 K253447 Montage Flowable Settable, Resorbable Bone…score 13.7 · 10 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? (4)

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
*	K051093	Osteopore PCL Scaffold Summary page 2 …he C-BVF devices. They are then returned to TRS and inventoried as Finished Goods. 7.0 Predicate Devices Osteopore PCIL Scaffold Bone Void Filler (BVF), (K051093, product code GXP cleared on March 17, 2006) Note: This device would be cleared under product code GXR if it were rev…	Osteopore, Inc.	2006	1
*	K071046	Synthes Chronos Composite Summary page 2 …ed under product code GXR if it were reviewed using today's more product specific product codes. Synthes chronOS Composite resorbable bone void filler (K071046, product code MQV, cleared on October 23, 2007). Synthes chronOS, porous, osteocondluctive, resorbable bone void fil…	Synthes (Usa)	2007	—
*	K041350	Synthes (Usa) Chronos Summary page 2 …ble bone void filler (K071046, product code MQV, cleared on October 23, 2007). Synthes chronOS, porous, osteocondluctive, resorbable bone void filler (K041350, product code GXP, cleared on July 8, 2004). Synthes Rapid Resorbable Cranial Clamp burr hole cover (K041 61 1, prod…	Synthes (Usa)	2004	—
*	K041611	Synthes (Usa) Rapid Resorbable Cranial Clamp Summary page 2 …osteocondluctive, resorbable bone void filler (K041350, product code GXP, cleared on July 8, 2004). Synthes Rapid Resorbable Cranial Clamp burr hole cover (K041 61 1, product code GXR, cleared on September 8, 2004. 8.0 Comparison to Marketed Devices - Tissue Rege…	Synthes (Usa)	2004	—

Also cleared against K051093: 1 other device →

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 11 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
1 of the 9 ancestors has a recall of any class.
1 other device also cites its predicate K051093.

How does its category compare?

All GXR devices

GXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · GXR

1in 2024

2007high 4 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXR

116in 2013

2007high 116 (2013)2026

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

Recalls per year · GXR

No recall names GXR since 2007.

Adverse event reports per year · GXR

10in 2025

2007high 45 (2018) · low 0 (2009)2025

MAUDE reports naming product code GXR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	3
2008	0	—	2
2009	0	—	0
2010	2	—	1
2011	0	—	4
2012	0	—	4
2013	4	116	4
2014	2	—	2
2015	0	—	7
2016	2	—	7
2017	0	—	7
2018	2	—	45
2019	0	—	28
2020	2	—	16
2021	0	—	28
2022	0	—	13
2023	1	—	11
2024	1	—	3
2025	0	—	10
2026	1	—	—

What is it indicated for?

TRS C-BVF is intended for use in the repair of 13 mm neurosurgical cranial burr holes. It should be gently packed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123633 · printed Nov 4, 2026

Cite this page

510(k) Report. “K123633: TRS Cranial Bone Void Filler (TRS C-BVF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123633

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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