510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915240Substantially Equivalent

Natural-Knee Tibial and Femoral Spacers

Intermedics Orthopedics, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915240 is the FDA 510(k) clearance record for NATURAL-KNEE TIBIAL AND FEMORAL SPACERS, a class II device, cleared for Intermedics Orthopedics on under FDA product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer). FDA records list 108 510(k) clearances for Intermedics Orthopedics, from to . As of , FDA records show no recalls naming K915240.

Clearance record

Decision date
Received
(71 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
Intermedics Orthopedics 1300 E. Anderson Ln., Austin TX
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 November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HSX, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260