510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965198Substantially Equivalent

Ultima Tps Cemented Stem

Johnson & Johnson International, Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965198 is the FDA 510(k) clearance record for ULTIMA TPS CEMENTED STEM, a class II device, cleared for Johnson & Johnson International on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 10 510(k) clearances for Johnson & Johnson International, from to . As of , FDA records show no recalls naming K965198.

Clearance record

Decision date
Received
(209 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Johnson & Johnson International 325 Paramount Dr., Raynham MA
510(k) summary
Summary
Third party review
No

Clearances, product code KWL

Trailing 12 months
3 clearances under product code KWL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260