Cleared Traditional

K882146 - BIOPRO PC FEMORAL HIP COMPONENT

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

K882146 · Biopro, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K882146

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.

JDI Device Classification - Class 2, Special Controls

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 515
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