510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961939Substantially Equivalent

S-Rom Femoral Hip Stem(sizes 12 X 06 X 115 and 12 X 07 X 115)

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

K961939 is the FDA 510(k) clearance record for S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115), a class II device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K961939.

Clearance record

Decision date
Received
(85 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Johnson & Johnson Professionals, Inc. 325 Paramount Dr., Raynham MA
510(k) summary
Summary
Third party review
No

Clearances, product code LPH

Trailing 12 months
11 clearances under product code LPH in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
November 20252
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260