Cleared Traditional

K912369 - HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BI...

K912369 is an FDA 510(k) clearance for HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BI..., manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K912369 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
135d
Days
Class 2
Risk

K912369 is an FDA 510(k) clearance for the HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT). Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 - K912369

510(k) Number K912369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1991
Decision Date October 11, 1991
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 132
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K912369.
HYDROXYAPATITE INFINITY TROCHANTERIC MODULE
K915350 · Dow Corning Wright · Feb 1992
S-ROM ZT HA PROXIMAL FEMORAL SLEEVE
K912713 · Joint Medical Products Corp. · Dec 1991
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
K913916 · Smith & Nephew Richards, Inc. · Dec 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · Biomet, Inc. · Oct 1991
HA MCCUTCHEN SLT HIP SYSTEM
K912452 · Dow Corning Wright · Oct 1991
DIMENSION-HA HIP PROSTHESIS
K912922 · Kirschner Medical Corp. · Oct 1991