Cleared Traditional

K882146 - BIOPRO PC FEMORAL HIP COMPONENT

K882146 is the FDA 510(k) clearance for BIOPRO PC FEMORAL HIP COMPONENT by Biopro, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K882146 · Biopro, Inc. · Orthopedic device
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Aug 1988
Decision
98d
Days
Class 2
Risk

K882146 is an FDA 510(k) clearance for the BIOPRO PC FEMORAL HIP COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on August 29, 1988 after a review of 98 days - within the typical 510(k) review window.

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: 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 Biopro, Inc. devices

Submission Details

510(k) Number K882146 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 23, 1988
Decision Date August 29, 1988
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 448
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K882146.
GEMINI FEMORAL HIP PROSTHESIS
K883724 · Depuy, Inc. · Nov 1988
TOWNLEY COX COMB ACETABULAR COMPONENT
K882869 · Biopro, Inc. · Oct 1988
FOCUS TOTAL HIP SYSTEM
K883460 · Depuy, Inc. · Oct 1988
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
K882812 · Osteonics Corp. · Aug 1988
PROFORMA/PS TOTAL HIP SYSTEM
K880435 · Orthomet, Inc. · Jun 1988
HJD CALCAR REPLACEMENT PROSTHESIS
K881769 · Richards Medical Co., Inc. · Jun 1988