Cleared Traditional

K973453 - TORNIER CEMENT RESTRICTOR

K973453 is the FDA 510(k) clearance for TORNIER CEMENT RESTRICTOR by Tornier. It is a Class 2 General & Plastic Surgery device (product code JDI) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K973453 · Tornier · General & Plastic Surgery device
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Dec 1997
Decision
89d
Days
Class 2
Risk

K973453 is an FDA 510(k) clearance for the TORNIER CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Tornier (Concord, US). The FDA issued a Cleared decision on December 9, 1997 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 888.3350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tornier devices

Submission Details

510(k) Number K973453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1997
Decision Date December 09, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 433
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K973453.
ENCORE LINEAR HIP
K972791 · Encore Orthopedics, Inc. · Jan 1998
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K973809 · Encore Orthopedics, Inc. · Jan 1998
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K974054 · Howmedica, Inc. · Dec 1997
EXTEND HIP STEM
K973296 · Wrightmedicaltechnologyinc · Nov 1997
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
K972995 · Corin USA · Nov 1997
STELKAST BIPOLAR SYSTEM
K972961 · Stelkast Company · Nov 1997