Cleared Traditional

K954598 - OSTEONICS OFFSET HIP STEMS

K954598 is the FDA 510(k) clearance for OSTEONICS OFFSET HIP STEMS by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K954598 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
184d
Days
Class 2
Risk

K954598 is an FDA 510(k) clearance for the OSTEONICS OFFSET HIP STEMS. 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 April 4, 1996 after a review of 184 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

Submission Details

510(k) Number K954598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1995
Decision Date April 04, 1996
Days to Decision 184 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
62d slower than avg
Panel avg: 122d · This submission: 184d
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 K954598.
PROTEK LOW PROFILE ACETABULAR CUP
K960025 · Intermedics Orthopedics · Jun 1996
BURCH/SCHNEIDER REINFORCEMENT CAGE
K960678 · Intermedics Orthopedics · May 1996
MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)
K960626 · Intermedics Orthopedics · Apr 1996
GAMMA SYSTEM
K955473 · Zimmer, Inc. · Feb 1996
ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT
K952859 · Johnson & Johnson Professionals, Inc. · Jan 1996
ULTIMA SIZE 0 CEMENTED FEMORAL STEM
K953200 · Johnson & Johnson Professionals, Inc. · Jan 1996