Cleared Traditional

K882869 - TOWNLEY COX COMB ACETABULAR COMPONENT

K882869 is the FDA 510(k) clearance for TOWNLEY COX COMB ACETABULAR COMPONENT by Biopro, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K882869 · Biopro, Inc. · Orthopedic device
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Oct 1988
Decision
95d
Days
Class 2
Risk

K882869 is an FDA 510(k) clearance for the TOWNLEY COX COMB ACETABULAR 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 October 14, 1988 after a review of 95 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 K882869 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 11, 1988
Decision Date October 14, 1988
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 K882869.
PROFORMA HIP SYSTEM
K883941 · Orthomet, Inc. · Nov 1988
MODULAR COLLARED HJD TOTAL HIP SYSTEM
K884457 · Richards Medical Co., Inc. · Nov 1988
GEMINI FEMORAL HIP PROSTHESIS
K883724 · Depuy, Inc. · Nov 1988
FOCUS TOTAL HIP SYSTEM
K883460 · Depuy, Inc. · Oct 1988
BIOPRO PC FEMORAL HIP COMPONENT
K882146 · Biopro, Inc. · Aug 1988
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
K882812 · Osteonics Corp. · Aug 1988