510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954186Substantially Equivalent

Sled Unicompartment Knee System

Link America, Inc., East Hanavor NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954186 is the FDA 510(k) clearance record for SLED UNICOMPARTMENT KNEE SYSTEM, a class II device, cleared for Link America, Inc. on under FDA product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer). FDA records list 21 510(k) clearances for Link America, Inc., from to . As of , FDA records show 32 recalls naming K954186.

Clearance record

Decision date
Received
(142 days to decision)
Product code
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3520
Device class
Class II
Review panel
Orthopedic
Applicant
Link America, Inc. C/O Surgical Implants, Inc., East Hanavor NJ
510(k) summary
Statement
Third party review
No

Clearances, product code HSX

Trailing 12 months
2 clearances under product code HSX 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 HSX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260