Cleared Traditional

K831792 - SELF-ALIGNING ACETABULAR COMPONENT

K831792 is an FDA 510(k) clearance for SELF-ALIGNING ACETABULAR COMPONENT, manufactured by Endomedics, Inc.. The device is a Class 3 Orthopedic device with product code JDL cleared through the Traditional 510(k) pathway after a 475-day FDA review.

K831792 · Endomedics, Inc. · Orthopedic device
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Sep 1984
Decision
475d
Days
Class 3
Risk

K831792 is an FDA 510(k) clearance for the SELF-ALIGNING ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Endomedics, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 475 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3320 - 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: High-complexity regulatory submission. High regulatory complexity profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

FDA 510(k) Submission Details - K831792

510(k) Number K831792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date September 20, 1984
Days to Decision 475 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 122d · This submission: 475d
Pathway characteristics
Predicate-based equivalence.

JDL Device Classification - Class 3, Premarket Approval

Product Code JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3320
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

All 44
Devices cleared under the same product code (JDL) and FDA review panel - the closest regulatory comparables to K831792.
MICRO-STRUC. ACETABULAR COMPON- MC2P
K850352 · Osteonics Corp. · Apr 1985
MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
K844482 · Advanced Biosearch Assn. · Feb 1985
DORR HIP PROSTHESIS, ACETABULAR COMPON
K842893 · Carbomedics, Inc. · Nov 1984
NATURAL LOCK ACETABULAR COMPONENT
K830662 · Advanced Biosearch Assn. · Apr 1983
101-32 FEMORAL COMPONENT
K813599 · Intermedics Orthopedics · Jan 1982
BG PROXIMAL FEMUR
K790274 · Howmedica Corp. · Mar 1979
K831792 · SELF-ALIGNING ACETABULAR COMPONENT
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