510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K101859Substantially Equivalent

Rel-K Artifical Limb Prosthesis

Rizzoli Ortopedica S.p.A., Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101859 is the FDA 510(k) clearance record for REL-K ARTIFICAL LIMB PROSTHESIS, a class I device, cleared for Rizzoli Ortopedica S.P.A. on under FDA product code ISY (Joint, Knee, External Limb Component). FDA records list one 510(k) clearance for Rizzoli Ortopedica S.P.A. As of , FDA records show no recalls naming K101859.

Clearance record

Decision date
Received
(103 days to decision)
Product code
ISY Joint, Knee, External Limb Component
Regulation
21 CFR 890.3420
Device class
Class I
Review panel
Physical Medicine
Applicant
Rizzoli Ortopedica S.P.A. 58a Bates Rd., Watertown MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ISY

Trailing 12 months

FDA records hold no clearances under product code ISY in the trailing twelve months.

FDA records show no clearances under product code ISY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ISY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260