510(k) · Cleared

Cleared

Trabecular Metal Vertebral Body Replacement

K051978510(k) SpecialCleared Sep 23, 200564-day reviewClass II21 CFR 888.3060

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

Implex Corp. · MQP Spinal Vertebral Body Replacement Device

Cleared on Sep 23, 2005 as substantially equivalent to K010378 (Implex Corp., 2002) and 6 other predicates after a 64-day review. Its family tree reaches back 5 generations to 2001. 22 later devices descend from it.

Decided: Sep 23, 2005
Review: 64 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 7

Its longest line of descent runs back 5 generations to K003709 (2001). 8 ancestors in all. 22 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK003709 Surgical Dynamics Mesh Cage SystemUnited States Surgical, A Division of Tyco Healthc · 2001
4 generations backK021025 Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZImplex Corp. · 2002
3 generations backK021967 Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and…Implex Corp. · 2002
2 generations backK022563 Hydrocel Vertebral Body Replacement, Model 06-172-00XX1Implex Corp. · 2002
1 generation backK051196 Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and…Implex Corp. · 2005
This deviceK051978 Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
Descendant · cites it directly · 21 of its ownK052950 The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular · 2005
Descendant · 2 generations on · 20 of its ownK120203 TM-400 DeviceZimmer Trabecular Metal Technology, Inc. · 2012
Descendant · 3 generations on · 19 of its ownK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
Descendant · 4 generations on · 11 of its ownK162986 SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
Descendant · 5 generations on · 10 of its ownK180724 SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005high 3 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 22 · See all

K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular · 2005 · cites it directly21descendants
K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc. · 2012 · 2 generations on20descendants
K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc. · 2015 · 3 generations on19descendants
K162986SPIRA Open Matrix ALIFCamber Spine Technologies · 2017 · 4 generations on11descendants
K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018 · 5 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K003709	Surgical Dynamics Mesh Cage System	United States Surgical, A Division of Tyco Healthc	2001	—
−4	K021025	Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ	Implex Corp.	2002	—
−3	K021967	Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2	Implex Corp.	2002	—
−2	K022563	Hydrocel Vertebral Body Replacement, Model 06-172-00XX1	Implex Corp.	2002	—
−1	K051196	Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1	Implex Corp.	2005	—
0 (this device)	K051978	Trabecular Metal Vertebral Body Replacement	Implex Corp.	2005	—
+1	K052950	The Zimmer TMT Trabecular Metal Vertebral Body Replacement System	Zimmer Trabecular	2005	—
+2	K120203	TM-400 Device	Zimmer Trabecular Metal Technology, Inc.	2012	—
+3	K143297	Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical…	Zimmer Spine, Inc.	2015	—
+4	K162986	SPIRA Open Matrix ALIF	Camber Spine Technologies	2017	—
+5	K180724	SPIRA Open Matrix LLIF	Camber Spine Technologies, LLC	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2012	1	0
2015	1	0
2016	1	0
2017	2	0
2018	1	0
2019	1	0
2020	1	0
2021	2	0
2022	2	0
2023	1	0
2024	3	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K051978, 2001–2026Source: 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 MQP? 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 MQP device

#1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K010378	Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ Summary page 1 …rtebral Body Replacement System is substantially equivalent to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the…	Implex Corp.	2002	—
*	K021025	Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ Summary page 1 …ody Replacement System is substantially equivalent to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the Signus =…	Implex Corp.	2002	—
*	K021967	Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2 Summary page 1 …cement System is substantially equivalent to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the Signus === Page 2…	Implex Corp.	2002	—
*	K022563	Hydrocel Vertebral Body Replacement, Model 06-172-00XX1 Summary page 1 …stem is substantially equivalent to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the Signus Zim…	Implex Corp.	2002	—
*	K031823	Hedrocel Vertebral Body Replacement, Model 06-172-00XX1 Summary page 1 …ubstantially equivalent to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the Signus Zimmer TMT…	Implex Corp.	2003	—
*	K032527	Hedrocel Vertebral Body Replacement Summary page 1 …lly equivalent to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the Signus Zimmer TMT…	Implex Corp.	2003	—
*	K051196	Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1 Summary page 1 …to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the Signus Zimmer TMT TrabecularMet…	Implex Corp.	2005	—
†	K022793	Tetris Spinal Implant	Signus Medical, LLC	2003	—
†	K041888	Curved Peek Tetris Spinal Implant	Signus Medizintechnik GmbH	2004	—
†	K043316	Rabea Spinal Implant	Signus Medizintechnik GmbH	2005	—

Also cleared against K010378: 7 other devices →

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052950	The Zimmer TMT Trabecular Metal Vertebral Body Replacement System	Zimmer Trabecular	2005	21

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 4 years and passes through 2 companies; a new generation was cleared every 3 months on median.
None of the 8 ancestors has a recall.
Of its descendants, K052950 (Zimmer Trabecular, 2005) has gone furthest, with 21 descendants of its own.
7 other devices also cite its predicate K010378.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007high 15 (2020) · low 0 (2008)2026

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

Adverse event reports per year · MQP

168in 2025

2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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	30	107	2	61
2008	17	47	0	76
2009	11	115	14	111
2010	6	174	2	166
2011	8	237	1	121
2012	7	82	2	141
2013	3	90	0	207
2014	5	125	0	216
2015	8	126	0	258
2016	0	—	0	129
2017	9	97	0	141
2018	6	152	0	130
2019	8	93	0	117
2020	3	103	15	157
2021	0	—	0	208
2022	1	—	1	137
2023	1	—	0	71
2024	4	187	0	98
2025	0	—	0	168
2026	3	102	0	—

What is it indicated for?

The Trabecular Metal Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051978 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051978: Trabecular Metal Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051978

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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