Cleared Traditional

K821713 - POROCOAT LOW PROFILE METAL BACKED CUP

K821713 is the FDA 510(k) clearance for POROCOAT LOW PROFILE METAL BACKED CUP by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K821713 · Depuy, Inc. · Orthopedic device

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Aug 1982

Decision

71d

Days

Class 2

Risk

K821713 is an FDA 510(k) clearance for the POROCOAT LOW PROFILE METAL BACKED CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Walker, US). The FDA issued a Cleared decision on August 20, 1982 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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

Submission Details

510(k) Number	K821713 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 10, 1982
Decision Date	August 20, 1982
Days to Decision	71 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

51d faster than avg

Panel avg: 122d · This submission: 71d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 888.3350

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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451

Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K821713.

SPECTRON METAL BACK ACETABULAR COMPONENT

K823729 · Richard'S Medical Equip., Inc. · Jan 1983

HC 1M METALBACKED ACETABULAR CUP

K823419 · Osteonics Corp. · Jan 1983

ZIMMER METAL BACKED ACETABULAR CUP

K821893 · Zimmer, Inc. · Sep 1982

POROCOAT STANDARD METAL BACKED CUP

K821714 · Depuy, Inc. · Aug 1982

TITANIUM AUFRANC-TURNER ATS HIP SYS

K821369 · Howmedica Corp. · May 1982

CONTOUR II LINK SP TOTAL HIP PROSTHESIS

K821066 · C.R. Bard, Inc. · Apr 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K821713

Depuy, Inc.

Walker, MI · US

Regulatory profile

303 submissions 239 cleared

79% clearance rate · Active in Orthopedic

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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