Cleared Traditional

K894604 - BIOPRO PROXIMAL FEMORAL ARTICULAR REPLA...

K894604 is the FDA 510(k) clearance for BIOPRO PROXIMAL FEMORAL ARTICULAR REPLA... by Biopro, Inc.. It is a Class 2 Orthopedic device (product code KXA) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K894604 · Biopro, Inc. · Orthopedic device
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Nov 1989
Decision
120d
Days
Class 2
Risk

K894604 is an FDA 510(k) clearance for the BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3400 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biopro, Inc. devices

Submission Details

510(k) Number K894604 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 20, 1989
Decision Date November 17, 1989
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXA Prosthesis, Hip, Femoral, Resurfacing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KXA Prosthesis, Hip, Femoral, Resurfacing

All 17
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K894604.
NELSON RESURFACING HEAD
K983452 · Biomet, Inc. · Dec 1998
MODUILAR UNIPOLAR
K950998 · Intermedics Orthopedics · Apr 1995
ORTHOMET RESURFACING FEMORAL COMPONENT
K944752 · Orthomet, Inc. · Dec 1994
BIPOLAR HIP SYSTEM
K892398 · Orthomet, Inc. · May 1989
TILLMAN HIP RESURFACING REPLACEMT PROS.
K792200 · Waldemar Link GmbH & Co. KG · Dec 1979
TILLMAN HIPSURFACE REPLACEMENT
K781490 · Waldemar Link GmbH & Co. KG · Sep 1978