BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE— 510(k) K890044

Clearance details

Applicant

Biopro, Inc.

Product code

Code HRY

Device class

Class 2

Regulation

21 CFR 888.3530

Advisory panel

Orthopedic

Date received

1989-01-05

Decision date

1989-11-06

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Port Huron, MI, US

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• K163627 — Shotel Ankle Arthrodesis Nail System2017-09-14
• K162674 — BioPro Foot Plating Systems2017-06-16
• K132510 — BIOPRO - INFINITY PLATE ANCHOR SYSTEM2013-10-24
• K130298 — BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM2013-06-18
• K121973 — BIOPRO HEMI-EDGE TOE SYSTEM2012-10-30

Injury

1,551

Malfunction

2,753

Total

4,304

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →