Cleared Traditional

GAS PLASMA STERILIZATION (K972774) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972774 · Zimmer, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
650d
Days
Class 2
Risk

K972774 is an FDA 510(k) clearance for the GAS PLASMA STERILIZATION. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 5, 1999 after a review of 650 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 888.3560 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K972774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date May 05, 1999
Days to Decision 650 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
521d slower than avg
Panel avg: 129d · This submission: 650d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 Hospital devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 910
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K972774.
NovoKnee (SteriKnee)
K261032 · NovoSource · Apr 2026
Materialise TKA Guide System
K253793 · Materialise NV · Jan 2026
EMPOWR Knee
K252974 · Encore Medical, L.P. · Dec 2025
ATTUNE™ Total Knee System
K253197 · Depuy Ireland UC · Nov 2025
Freedom Infinia™ Total Knee System
K253314 · Maxx Orthopedics, Inc. · Oct 2025
Freedom® Total Knee System – Titan PCK Components
K253144 · Maxx Orthopedics, Inc. · Oct 2025