Cleared Traditional

K864085 - BROOKER BIO-GROOVE FEMORAL COMPONENT

K864085 is an FDA 510(k) clearance for BROOKER BIO-GROOVE FEMORAL COMPONENT, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K864085 · Biomet, Inc. · Orthopedic device
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Jan 1987
Decision
100d
Days
Class 2
Risk

K864085 is an FDA 510(k) clearance for the BROOKER BIO-GROOVE FEMORAL COMPONENT. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 28, 1987 after a review of 100 days - within the typical 510(k) review window.

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: 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K864085

510(k) Number K864085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1986
Decision Date January 28, 1987
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWL Device Classification - Class 2, Special Controls

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 77
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K864085.
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS
K872025 · Depuy, Inc. · Aug 1987
TRI-LOCK MODIFIED FEMORAL PROSTHESIS
K872878 · Depuy, Inc. · Aug 1987
ORTHOMET AUSTIN-MOORE SYSTEM
K871656 · Orthomet, Inc. · Jun 1987
BIO-FIT HIP SYSTEM
K854791 · Richards Medical Co., Inc. · Feb 1986
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584 · Biomet, Inc. · Aug 1985
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
K844818 · Osteonics Corp. · Jul 1985