Cleared Traditional

K852546 - HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY

K852546 is an FDA 510(k) clearance for HOWMEDICA CEMENTED FLANGED ACETABULAR C..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K852546 · Howmedica Corp. · Orthopedic device
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Aug 1985
Decision
68d
Days
Class 2
Risk

K852546 is an FDA 510(k) clearance for the HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 68 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K852546

510(k) Number K852546 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 14, 1985
Decision Date August 21, 1985
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 514
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K852546.
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K852585 · Biomet, Inc. · Aug 1985
THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
K852153 · Howmedica Corp. · Aug 1985
LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
K852705 · Waldemar Link GmbH & Co. KG · Aug 1985
MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
K844817 · Osteonics Corp. · Mar 1985