Cleared Traditional

K894604 - BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT

K894604 is an FDA 510(k) clearance for BIOPRO PROXIMAL FEMORAL ARTICULAR REPLA..., manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K894604

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.

KXA Device Classification - Class 2, Special Controls

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