Cleared Traditional

K972995 - THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM

K972995 is an FDA 510(k) clearance for THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972995 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
90d
Days
Class 2
Risk

K972995 is an FDA 510(k) clearance for the THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on November 10, 1997 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 Corin USA devices

FDA 510(k) Submission Details - K972995

510(k) Number K972995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date November 10, 1997
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.

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 466
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K972995.
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K974054 · Howmedica, Inc. · Dec 1997
TORNIER CEMENT RESTRICTOR
K973453 · Tornier · Dec 1997
EXTEND HIP STEM
K973296 · Wrightmedicaltechnologyinc · Nov 1997
STELKAST BIPOLAR SYSTEM
K972961 · Stelkast Company · Nov 1997
KERBOULL CROSS
K972928 · Howmedica, Inc. · Nov 1997
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
K972792 · Howmedica Corp. · Oct 1997