Cleared Traditional

K001046 - BIOPRO GLENOID COMPONENT W/ KEEL & W/ P...

K001046 is the FDA 510(k) clearance for BIOPRO GLENOID COMPONENT W/ KEEL & W/ P... by Biopro, Inc.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K001046 · Biopro, Inc. · Orthopedic device
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Jun 2000
Decision
69d
Days
Class 2
Risk

K001046 is an FDA 510(k) clearance for the BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on June 8, 2000 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 K001046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2000
Decision Date June 08, 2000
Days to Decision 69 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 153
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K001046.
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
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K001706 · Wrightmedicaltechnologyinc · Aug 2000
AEQUALIS UNIVERSAL SHOULDER GLENOID
K994393 · Tornier · Jun 2000
NEER III TOTAL SHOULDER SYSTEM
K994350 · Smith & Nephew, Inc. · May 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · DePuy Orthopaedics, Inc. · Mar 2000
AEQUALIS SHOULDER FRACTURE SYSTEM
K994392 · Tornier · Mar 2000