510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K852420Substantially Equivalent

Btm Total Hip System

Kirschner Medical Corp., Timonium MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852420 is the FDA 510(k) clearance record for BTM TOTAL HIP SYSTEM, a class II device, cleared for Kirschner Medical Corp. on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 76 510(k) clearances for Kirschner Medical Corp., from to . As of , FDA records show no recalls naming K852420.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Kirschner Medical Corp. 9690 Deereco Rd.D, Timonium MD
Third party review
No

Clearances, product code KWL

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