510(k) Report

510(k) · Cleared

Cleared

SSP Vertebral Body Replacement

K061578510(k) TraditionalCleared Dec 26, 2006202-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

Specialty Spine Products, LLC · MQP Spinal Vertebral Body Replacement Device

Cleared on Dec 26, 2006 as substantially equivalent to K003275 (Synthes (Usa), 2001) and 2 other predicates after a 202-day review. Its family tree reaches back 3 generations to 2001.

Decided
Dec 26, 2006
Review
202 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K003275 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalledK030744 · Blackstone Surgical Titanium Mesh · Blackstone Medical, Inc. · 2003K032700 · Blackstone Surgical Titanium Mesh System Angled End Rings · Blackstone Medical, Inc. · 200320002002200420062008
Other ancestors, by generation 2 generations back: 1 other ancestor K032700 · Blackstone Surgical Titanium Mesh System Angled End Rings · Blackstone Medical, Inc. · 2003K030744 · Blackstone Surgical Titanium Mesh · Blackstone Medical, Inc. · 2003K003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalled0
  1. Root · 3 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 2 generations backK030744 Blackstone Surgical Titanium MeshBlackstone Medical, Inc. · 2003
  3. 1 generation backK032700 Blackstone Surgical Titanium Mesh System Angled End RingsBlackstone Medical, Inc. · 2003
  4. This deviceK061578 SSP Vertebral Body ReplacementSpecialty Spine Products, LLC · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−2K030744Blackstone Surgical Titanium MeshBlackstone Medical, Inc.2003—
−1K032700Blackstone Surgical Titanium Mesh System Angled End RingsBlackstone Medical, Inc.2003—
0 (this device)K061578SSP Vertebral Body ReplacementSpecialty Spine Products, LLC2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K061578, 2001–2006Source: 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 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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (3)

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
*K003275Synthes Synmesh Spacer System
Summary page 2
…rinciples to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: the SynMesh Spacer System (K003275) from Synthes, the Blackstone Surgical Titanium Mesh System (K030744) from Blackstone Medical, and the Blackstone Surgical Titani…
Synthes (Usa)200114
*K030744Blackstone Surgical Titanium Mesh
Summary page 2
…determined by FDA to be substantially equivalent to preamendment devices: the SynMesh Spacer System (K003275) from Synthes, the Blackstone Surgical Titanium Mesh System (K030744) from Blackstone Medical, and the Blackstone Surgical Titanium Mesh System Angled End Rings (K032700), also from Blackstone Medic…
Blackstone Medical, Inc.2003—
*K032700Blackstone Surgical Titanium Mesh System Angled End Rings
Summary page 2
…K003275) from Synthes, the Blackstone Surgical Titanium Mesh System (K030744) from Blackstone Medical, and the Blackstone Surgical Titanium Mesh System Angled End Rings (K032700), also from Blackstone Medical. K061578 R…
Blackstone Medical, Inc.2003—

Also cleared against K003275: 12 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 5 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 12 other devices also cite its predicate K003275.

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

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
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

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement

device intended for use in the thoracolumbar spine (Ti - L5) to provide anterior and

middle column support after removal or resection of a damaged, collapsed, or unstable

vertebral body due to tumor or trauma (e.g., fracture).

The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine

Products Pedicle Screw System or with supplemental internal fixation systems cleared for

the conditions listed above, and is intended to be used with bone graft. It is designed to

provide anterior column support even in the absence of fusion for a prolonged period.

Indications for use as stated in the FDA summary.

Also cleared against K003275

12 other devices cite the same predicate.

  • K183054SYNMESH SystemDepuy Synthes Spine · 2019
  • K121176STGCCardinal Spine, LLC · 2012
  • K103320Synthes XRLSynthes Spine Co.Lp · 20111 recall
  • K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
  • K070381Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
  • K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2005

More from Specialty Spine Products, LLC

2 FDA decisions under this applicant name. See the company

  • K060118SSP Pedicle Screw SystemSpecialty Spine Products, LLC · 2006

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K061578 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061578: SSP 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/K061578

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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