VBB SYSTEM— 510(k) K110604

Clearance details

Applicant

Synthes

Product code

Code NDN

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2011-03-03

Decision date

2011-12-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Chester, PA, US

• K251896 — XeliteMed SuperM-Fix Spinal Bone Cement2026-01-28
• K250637 — VCFix Spinal System2025-05-30
• K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System2025-04-11
• K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement2024-09-18
• K232842 — Balloon Inflation System2024-02-29

• K123723 — SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM2013-09-05
• K122455 — SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM2013-04-11
• K113071 — SYNTHECEL DURA REPLACEMENT DEVICES2012-01-09
• K093772 — SYNTHES STERNAL FIXATION SYSTEM2010-03-29
• K013072 — CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)2002-11-26

Death

24

Injury

407

Malfunction

1,975

Total

2,406

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0877-2015 — Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheterClass II·Terminated·PEROUSE MEDICAL·20141006

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110604.