Cleared Traditional

K895886 - BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL S...

K895886 is the FDA 510(k) clearance for BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL S... by Biopro, Inc.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K895886 · Biopro, Inc. · Orthopedic device
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Dec 1989
Decision
57d
Days
Class 2
Risk

K895886 is an FDA 510(k) clearance for the BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on December 1, 1989 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biopro, Inc. devices

Submission Details

510(k) Number K895886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1989
Decision Date December 01, 1989
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 75
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K895886.
AUSTIN MOORE TYPE HIP PROSTHESIS
K903241 · Onyx Medical Corp. · Jul 1990
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853 · Howmedica Corp. · May 1990
EVOLUTION HIP SYSTEM
K896105 · Dow Corning Wright · Dec 1989
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482 · Depuy, Inc. · May 1989
HIP FRACTURE STEM SYSTEM
K883179 · Howmedica Corp. · Sep 1988
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
K874915 · Orthomet, Inc. · Feb 1988