510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K112898Substantially Equivalent

Delta Tt Cups, Delta Tt Liners, Bone Screws

Lima Corporate S.p.A., Winona Lake IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112898 is the FDA 510(k) clearance record for DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS, a class II device, cleared for Lima Corporate S.P.A. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 64 510(k) clearances for Lima Corporate S.P.A., from to . As of , FDA records show no recalls naming K112898.

Clearance record

Decision date
Received
(445 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
Lima Corporate S.P.A. P.O. Box 696, Winona Lake IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPH

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