Cleared Traditional

K871867 - ELITE MODULAR HIP SYSTEM

K871867 is an FDA 510(k) clearance for ELITE MODULAR HIP SYSTEM, manufactured by Thackray USA. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K871867 · Thackray USA · Orthopedic device
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Apr 1988
Decision
331d
Days
Class 2
Risk

K871867 is an FDA 510(k) clearance for the ELITE MODULAR HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Thackray USA (Ringoes, US). The FDA issued a Cleared decision on April 8, 1988 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K871867

510(k) Number K871867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1987
Decision Date April 08, 1988
Days to Decision 331 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
209d slower than avg
Panel avg: 122d · This submission: 331d
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 552
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K871867.
HJD CALCAR REPLACEMENT PROSTHESIS
K881769 · Richards Medical Co., Inc. · Jun 1988
LCS FEMORAL HIP PROSTHESIS
K880269 · Depuy, Inc. · May 1988
RESUBMITTING OF HJD TOTAL HIP SYSTEM
K881117 · Richards Medical Co., Inc. · Apr 1988
INTRAFORM TOTAL HIP SYSTEM
K880390 · Orthomet, Inc. · Apr 1988
TITANIUM FEMORAL HIP
K881128 · Depuy, Inc. · Mar 1988
PERFECTA TOTAL HIP SYSTEM
K880461 · Orthomet, Inc. · Mar 1988
K871867 · ELITE MODULAR HIP SYSTEM
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