510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K991052Substantially Equivalent

Fs 1000 Knee System

Renaissance Instruments, LLC, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991052 is the FDA 510(k) clearance record for FS 1000 KNEE SYSTEM, a class II device, cleared for Renaissance Instruments, LLC on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list one 510(k) clearance for Renaissance Instruments, LLC. As of , FDA records show no recalls naming K991052.

Clearance record

Decision date
Received
(225 days to decision)
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Renaissance Instruments, LLC 370 Ninth Ave., Suite 205, Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code JWH

Trailing 12 months
14 clearances under product code JWH in the twelve months to October 2026, September 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code JWH, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20261
September 20266
October 20260