510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K970346Substantially Equivalent

Patient Specific Implant Hip Femoral Component

Kairos Orthopaedics, Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970346 is the FDA 510(k) clearance record for PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT, a class II device, cleared for Kairos Orthopaedics on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list one 510(k) clearance for Kairos Orthopaedics. As of , FDA records show no recalls naming K970346.

Clearance record

Decision date
Received
(20 days to decision)
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Kairos Orthopaedics 819 Striker Ave., Suite 10, Sacramento CA
510(k) summary
Summary
Third party review
No

Clearances, product code LZO

Trailing 12 months
9 clearances under product code LZO in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20262
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20261