Cleared Traditional

K923898 - C-FIT CEMENTED HIP STEM

K923898 is an FDA 510(k) clearance for C-FIT CEMENTED HIP STEM, manufactured by Turnkey Intergration USA, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K923898 · Turnkey Intergration USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
92d
Days
Class 2
Risk

K923898 is an FDA 510(k) clearance for the C-FIT CEMENTED HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 4, 1992 after a review of 92 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 Turnkey Intergration USA, Inc. devices

FDA 510(k) Submission Details - K923898

510(k) Number K923898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date November 04, 1992
Days to Decision 92 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 122d · This submission: 92d
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 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K923898.
PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP
K922733 · Orthomet, Inc. · Feb 1993
DEPUY HIP PROSTHESIS
K914078 · Depuy, Inc. · Jan 1993
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K920739 · Joint Medical Products Corp. · Nov 1992
LESTER PRESS FIT HIP PROSTHESIS
K915500 · Kirschner Medical Corp. · Oct 1992
KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP
K922421 · Kinamed, Inc. · Oct 1992
HOWMEDICA(R) HNR SYSTEM
K922503 · Howmedica Corp. · Sep 1992