Cleared Traditional

K834035 - UNIVERSAL SELF-ALIGNING ACETABULAR COM

K834035 is an FDA 510(k) clearance for UNIVERSAL SELF-ALIGNING ACETABULAR COM, manufactured by Orthopedic Equipment Co., Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K834035 · Orthopedic Equipment Co., Inc. · Orthopedic device
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Jun 1984
Decision
209d
Days
Class 2
Risk

K834035 is an FDA 510(k) clearance for the UNIVERSAL SELF-ALIGNING ACETABULAR COM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Orthopedic Equipment Co., Inc. (Walker, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 209 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 Orthopedic Equipment Co., Inc. devices

FDA 510(k) Submission Details - K834035

510(k) Number K834035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1983
Decision Date June 19, 1984
Days to Decision 209 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
87d slower than avg
Panel avg: 122d · This submission: 209d
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 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K834035.
HAP ACETABULAR CUP
K843190 · Depuy, Inc. · Nov 1984
TITANIUM HIP 1019
K843909 · Depuy, Inc. · Nov 1984
BIAS TOTAL HIP
K842906 · Zimmer, Inc. · Aug 1984
HARRIS-GALANTE POROUS TOTAL HIP SYS
K840643 · Zimmer, Inc. · Apr 1984
SSA HIP PROSTHESIS
K840357 · Dow Corning Corp. Healthcare Industries Materials · Feb 1984
GALANTE FIBER METAL TOTAL HIP
K833912 · Zimmer, Inc. · Dec 1983