Cleared Traditional

K974685 - OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS

K974685 is an FDA 510(k) clearance for OSTEONICS POLYETHYLENE ACETABULAR COMPO..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K974685 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
280d
Days
Class 2
Risk

K974685 is an FDA 510(k) clearance for the OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 280 days - an extended review 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: 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K974685

510(k) Number K974685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1997
Decision Date September 22, 1998
Days to Decision 280 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
158d slower than avg
Panel avg: 122d · This submission: 280d
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 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K974685.
DEPUY C-STEM SYSTEM
K982918 · DePuy Orthopaedics, Inc. · Oct 1998
OTI FEMORAL LOCK TOTAL HIP SYSTEM
K982598 · Osteoimplant Technology, Inc. · Oct 1998
CONTEMPORARY ACETABULAR COMPONENT
K982670 · Howmedica Corp. · Oct 1998
PRINCE MEDICAL CEMENT PLUG
K981855 · Prince Medical, Inc. · Aug 1998
RELIANCE LONG STEM FEMORAL COMPONENTS
K980813 · Howmedica, Inc. · Jun 1998
EXETER INTRAMEDULLARY BONE PLUG
K980843 · Howmedica, Inc. · Jun 1998