Cleared Traditional

K872776 - PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT

K872776 is an FDA 510(k) clearance for PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K872776 · Depuy, Inc. · Orthopedic device
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Aug 1987
Decision
41d
Days
Class 2
Risk

K872776 is an FDA 510(k) clearance for the PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 24, 1987 after a review of 41 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K872776

510(k) Number K872776 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 14, 1987
Decision Date August 24, 1987
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
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 K872776.
HIP FRACTURE STEM SYSTEM
K883179 · Howmedica Corp. · Sep 1988
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
K874915 · Orthomet, Inc. · Feb 1988
BIOPRO FEMORAL HIP COMPONENT
K872535 · Biopro, Inc. · Aug 1987
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