Cleared Traditional

AML BOWED FEMORAL HIP (K885338) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K885338 · Depuy, Inc. · Orthopedic device
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Mar 1989
Decision
77d
Days
Class 2
Risk

K885338 is an FDA 510(k) clearance for the AML BOWED FEMORAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 15, 1989 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy, Inc. devices

Submission Details

510(k) Number K885338 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 28, 1988
Decision Date March 15, 1989
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K885338.
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K894149 · Howmedica Corp. · Sep 1989
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
K894148 · Howmedica Corp. · Sep 1989
EXETER II TOTAL HIP SYSTEM
K891454 · Howmedica Corp. · Jun 1989
OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.
K890649 · Osteonics Corp. · Mar 1989
GEMINI FEMORAL HIP PROSTHESIS
K883724 · Depuy, Inc. · Nov 1988
FOCUS TOTAL HIP SYSTEM
K883460 · Depuy, Inc. · Oct 1988