Cleared Traditional

K952731 - TOWNLEY ALL POLY ACETABULAR CUP

K952731 is an FDA 510(k) clearance for TOWNLEY ALL POLY ACETABULAR CUP, manufactured by Biologically Oriented Prostheses. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K952731 · Biologically Oriented Prostheses · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
196d
Days
Class 2
Risk

K952731 is an FDA 510(k) clearance for the TOWNLEY ALL POLY ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biologically Oriented Prostheses (Port Huron, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 196 days - an extended review 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: 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 Biologically Oriented Prostheses devices

FDA 510(k) Submission Details - K952731

510(k) Number K952731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1995
Decision Date December 28, 1995
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
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 K952731.
ZCH ALPHA SYSTEM
K954744 · Zimmer, Inc. · Jan 1996
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
K952970 · Howmedica Corp. · Jan 1996
BETA FEMORAL HIP STEM
K945774 · Wrightmedicaltechnologyinc · Dec 1995
APR ACETABULAR INSERTS IOI BIPOLAR
K935585 · Intermedics Orthopedics · Dec 1995
REALITY LONG STEM HIP SYSTEM
K954219 · Kinamed, Inc. · Dec 1995
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K951139 · Wrightmedicaltechnologyinc · Nov 1995