510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170802Substantially Equivalent

TRAUMACEM™ V+ Injectable Bone Cement

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170802 is the FDA 510(k) clearance record for TRAUMACEM™ V+ Injectable Bone Cement, a class II device, cleared for Synthes (USA) Products, LLC on under FDA product code LOD (Bone Cement). FDA records list 479 510(k) clearances for Synthes (USA) Products, LLC, from to . As of , FDA records show no recalls naming K170802.

Clearance record

Decision date
Received
(195 days to decision)
Product code
LOD Bone Cement
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (USA) Products, LLC 1301 Goshen Pkwy., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LOD

Trailing 12 months
1 clearance under product code LOD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260