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
K080685Substantially Equivalent

Hiploc Compression Hip Screw

Biomet Manufacturing Corp, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080685 is the FDA 510(k) clearance record for HIPLOC COMPRESSION HIP SCREW, a class II device, cleared for Biomet Manufacturing, Inc. on under FDA product code JDO (Device, Fixation, Proximal Femoral, Implant). FDA records list 128 510(k) clearances for Biomet Manufacturing, Inc., from to . As of , FDA records show 4 recalls naming K080685.

Clearance record

Decision date
Received
(157 days to decision)
Product code
JDO Device, Fixation, Proximal Femoral, Implant
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet Manufacturing, Inc. P.O. Box 587, Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDO

Trailing 12 months

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

FDA records show no clearances under product code JDO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDO, 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