Cleared Traditional

K980843 - EXETER INTRAMEDULLARY BONE PLUG

K980843 is the FDA 510(k) clearance for EXETER INTRAMEDULLARY BONE PLUG by Howmedica, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980843 · Howmedica, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
90d
Days
Class 2
Risk

K980843 is an FDA 510(k) clearance for the EXETER INTRAMEDULLARY BONE PLUG. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on June 2, 1998 after a review of 90 days - within the typical 510(k) review window.

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 Howmedica, Inc. devices

Submission Details

510(k) Number K980843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1998
Decision Date June 02, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K980843.
CONTEMPORARY ACETABULAR COMPONENT
K982670 · Howmedica Corp. · Oct 1998
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
K974685 · Osteonics Corp. · Sep 1998
RELIANCE LONG STEM FEMORAL COMPONENTS
K980813 · Howmedica, Inc. · Jun 1998
DUAL LOCK HIP STEM
K980794 · Depuy, Inc. · May 1998
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
K980486 · Implex Corp. · Apr 1998
ARTICUL/EZE FEMORAL HEADS
K980513 · DePuy Orthopaedics, Inc. · Apr 1998