Cleared Traditional

K982670 - CONTEMPORARY ACETABULAR COMPONENT

K982670 is an FDA 510(k) clearance for CONTEMPORARY ACETABULAR COMPONENT, 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 63-day FDA review.

K982670 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
63d
Days
Class 2
Risk

K982670 is an FDA 510(k) clearance for the CONTEMPORARY ACETABULAR COMPONENT. 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 October 2, 1998 after a review of 63 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 - K982670

510(k) Number K982670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1998
Decision Date October 02, 1998
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K982670.
POLYMER THREADED ANCHOR / SUTURE COMBINATION
K982963 · Orthopaedic Biosystems, Ltd. · Nov 1998
DEPUY C-STEM SYSTEM
K982918 · DePuy Orthopaedics, Inc. · Oct 1998
OTI FEMORAL LOCK TOTAL HIP SYSTEM
K982598 · Osteoimplant Technology, Inc. · Oct 1998
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
K974685 · Osteonics Corp. · Sep 1998
PRINCE MEDICAL CEMENT PLUG
K981855 · Prince Medical, Inc. · Aug 1998
RELIANCE LONG STEM FEMORAL COMPONENTS
K980813 · Howmedica, Inc. · Jun 1998