Cleared Special

K022958 - TOTAL HIP FEMORAL HEADS AND LINERS

K022958 is an FDA 510(k) clearance for TOTAL HIP FEMORAL HEADS AND LINERS, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 26-day FDA review.

K022958 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
26d
Days
Class 2
Risk

K022958 is an FDA 510(k) clearance for the TOTAL HIP FEMORAL HEADS AND LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 2, 2002 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022958

510(k) Number K022958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date October 02, 2002
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 564
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K022958.
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · DePuy Orthopaedics, Inc. · Nov 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646 · Exactech, Inc. · Nov 2002
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
K023085 · Biomet Orthopedics, Inc. · Oct 2002
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K022077 · Howmedica Osteonics Corp. · Jul 2002
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
K022094 · Biomet, Inc. · Jul 2002
R120 MODULAR TOTAL HIP SYSTEM
K021822 · Osteoimplant Technology, Inc. · Jul 2002
K022958 · TOTAL HIP FEMORAL HEADS AND LINERS
Download PDF FDA Summary Smith & Nephew, Inc.